Monday, 7 April 2025

The Role of Academic Societies in Journal Publishing

 

The Role of Academic Societies in Journal Publishing

The Role of Academic Societies in Journal Publishing

Academic societies have long been integral to the advancement of research, education, and professional development in various fields. In the journal publishing, their influence is particularly notable. These organizations are often at the forefront of disseminating new scientific discoveries, setting rigorous standards for academic integrity, and fostering the growth of researchers through peer-reviewed publications. For medical writers, understanding the contributions of academic societies to journal publishing is essential, as it informs their work and ensures that the content they produce aligns with their highest academic and ethical standards.

  1. Setting and Maintaining Publishing Standards

One of the primary contributions of academic societies to journal publishing is their role in setting and maintaining high standards of scientific and academic content. These standards ensure that the research published in their journals is credible, rigorous, and adheres to the ethical guidelines.

  • Peer Review Process

The peer review process is a key mechanism by which academic societies maintain their publishing standards. Most academic journals, especially those affiliated with societies, require manuscripts to undergo rigorous peer review before publication. This process involved expert reviewers who evaluated the quality, originality, and validity of the research. By providing an independent assessment, peer review helps maintain the integrity of published research and prevents the dissemination of flawed or misleading findings.

For medical writers, the peer review process is both a guide and safeguard. When preparing manuscripts, regulatory documents, or clinical trial summaries, medical writers must ensure that their content meets the criteria set by the reviewers. This implies paying close attention to data accuracy, clarity of communication, and adherence to ethical standards.

  • Ethical Guidelines and Reporting Standards

Academic societies are instrumental in developing ethical guidelines and reporting standards for research publications. These include principles such as transparency in data reporting, disclosure of conflicts of interest, and adherence to ethical guidelines in human and animal research. For example, organizations like the International Committee of Medical Journal Editors (ICMJE) and Committee on Publication Ethics (COPE) have established widely accepted standards for manuscript preparation and publication ethics.

Medical writers working in the field of journal publishing must be familiar with these guidelines to ensure that their work complies with the industry norms. By adhering to the standards set by academic societies, medical writers contribute to the credibility and ethical standing of their research.

  1. Supporting Researchers: Providing a Platform for Scientific Dialogue

Another critical role that academic societies play in journal publishing is to provide a platform for researchers to share their findings, exchange ideas, and collaborate with their peers. By publishing journals, academic societies facilitate the dissemination of knowledge, ensuring that discoveries are accessible to the scientific community.

  • Encouraging Collaboration and Networking

Many academic societies organize conferences, workshops, and symposiums in addition to publishing journals. These events serve as valuable networking opportunities for researchers, where they can discuss their work with other professionals, receive feedback, and collaborate. For early career researchers, academic societies offer mentorship and support, helping them navigate the often-complex publishing process in high-impact journals.

Medical writers, particularly those involved in preparing research for publication, benefit from resources and networking opportunities provided by academic societies. Attending society-sponsored events or engaging with the latest journal articles allows medical writers to stay updated on emerging research trends, new methodologies, and shifts in the regulatory field.

  • Advancing Careers Through Recognition

Academic societies often have awards or recognition programs that honor outstanding research contributions. This recognition not only advances the careers of researchers, but also brings attention to important scientific discoveries. Many societies also offer travel grants, fellowships, and scholarships, to further support researchers in their professional development.

Medical writers, who often collaborate with researchers in preparing manuscripts and grant proposals, can help their clients or employers navigate these opportunities for recognition. By aligning their work with the high standards and expectations of academic societies, medical writers play a role in helping researchers advance their careers and secure the recognition of their contributions.

  1. Ensuring Accessibility and Credibility in Scientific Publishing

In recent years, the open-access movement has gained significant momentum, with the aim of making research freely available to a wider audience. Academic societies have been key players in this movement, with many offerings open-access options for their journals or participating in initiatives like Plan S, which promotes the unrestricted availability of scientific publications. By supporting open access, academic societies can help bridge the gap between researchers, clinicians, policymakers, and the public.

Read More: The Evolution of Academic Publishing: From Print to Digital

  • Enhancing Accessibility Through Open Access

The open-access model offers unique opportunities and challenges for medical writers. On one hand, open-access publications allow medical writers to access a wealth of research data and articles without barriers to paywalls. This is particularly useful when preparing literature reviews or drafting content that requires a comprehensive understanding of current research. However, open-access journals often require authors or their institutions to cover publication costs, which can be a financial burden for some researchers.

  • Upholding Journal Reputation and Impact

The reputation of a journal is often linked to the academic society that supports it. Journals affiliated with respected societies typically have higher impact factors, attract submissions from leading researchers, and maintain strict editorial standards. For medical writers, publishing in a high-impact journal can significantly enhance the visibility and credibility of the research they are helping communicate.

When preparing manuscripts, medical writers should consider the impact and reach of the journals they are targeting. Submitting work to society-affiliated journals that maintain high editorial standards can improve the likelihood of publication and ensure that research reaches the intended audience.

  1. Supporting Medical Writers: Collaboration Between Writers and Academic Societies

Academic societies are not only beneficial to researchers; they also play a crucial role in supporting medical writers. Many societies offer specialized resources to writers, including style guides, ethical guidelines, and access to professional networks. For example, organizations such as the American Medical Writers Association (AMWA) and European Medical Writers Association (EMWA) provide valuable training opportunities and certifications for medical writers.

  • Continuing Education and Professional Development

By collaborating with academic societies, medical writers can access continuing education opportunities that will help them stay current in their fields. Many societies offer workshops, webinars, and online courses that cover topics, like manuscript preparation, ethical writing practices, and advancements in medical research.

These educational opportunities not only enhance the skills of medical writers, but also contribute to the overall quality of the research publications they help produce. By being informed about the latest trends in medical writing and journal publishing, writers can improve the accuracy, clarity, and ethical standards of their work.

  • Bridging the Gap Between Researchers and Publishers

Medical writers often serve as intermediaries for researchers and publishers. By understanding the standards and requirements of academic societies, medical writers can help researchers navigate the publication process smoothly. This includes preparing manuscripts that meet society-specific guidelines, ensuring compliance with ethical standards, and facilitating clear communication between the authors and journal editors. Through this collaboration, medical writers contribute to the successful dissemination of research, ensuring that it reaches the right audience and has a lasting effect on the scientific community. The role of academic societies in journal publishing is essential to maintaining the integrity, accessibility, and credibility of scientific research.

At Turacoz, we understand the pivotal role academic societies play in setting rigorous standards for ethical and credible scientific communication. Our expert medical writers are dedicated to producing content that not only meets these high standards but also contributes to advancing scientific knowledge. Leveraging the resources and guidelines provided by academic societies, we ensure the accuracy, credibility, and impact of the research we help communicate. We stay updated on emerging trends and innovations in publishing, such as open-access platforms and transparent peer review processes, guiding researchers through the complexities of today’s academic landscape. By partnering with Turacoz, you gain a dedicated ally who is equipped to elevate your research, ensuring it meets the highest academic standards while reaching the widest possible audience. Visit www.turacoz.com or contact us at info@turacoz.com to learn how we can support your publishing journey

Thursday, 3 April 2025

Are Real-World Studies Reliable? Addressing Bias & Data Quality Issues

 

Are Real-World Studies Reliable? Addressing Bias & Data Quality Issues

In an era where healthcare decisions are increasingly driven by data, real-world evidence (RWE) has become a crucial tool for assessing treatment effectiveness beyond controlled medical trials. Real-world data (RWD) provides insights into how medical interventions perform across diverse patient populations in routine practice. However, concerns regarding bias, data integrity, and regulatory compliance raise an important question: How reliable are real-world studies?

The Growing Importance of RWE

Unlike traditional clinical trials, which follow strict protocols and eligibility criteria, real-world studies rely on data from electronic health records (EHRs), insurance claims, patient registries, and even wearable devices. This shift allows researchers, policymakers, and healthcare professionals to evaluate the long-term safety, cost-effectiveness, and impact of treatments in real-world settings.

Medical affairs teams use RWE to support health economics research, inform market access strategies, and guide regulatory decision-making. However, ensuring the credibility of findings requires a proactive approach to addressing biases and enhancing data quality.

Common Biases in Real-world Studies

Real-world studies are vulnerable to multiple forms of bias, which can compromise their reliability:

Selection bias: Since real-world studies do not employ randomized patient selection, certain demographic or clinical groups may be overrepresented or underrepresented, leading to skewed results.

Confounding variables: Unlike randomized controlled trials (RCTs), real-world studies often lack mechanisms to isolate variables, making it difficult to establish causality.

Reporting bias: Incomplete or inconsistent data entry in electronic health records and insurance claims databases can introduce errors that affect study conclusions.

Publication bias: Studies with favorable outcomes are more likely to be published, creating an incomplete picture of a treatment’s true effectiveness.

Mitigating Bias in RWE

Several methodologies can help mitigate bias in RWE studies:

Propensity score matching (PSM): This statistical technique matches patients with similar baseline characteristics to reduce confounding.

Inverse probability weighting (IPW): A weighting method that adjusts for imbalances in patient characteristics, improving comparability.

Sensitivity analyses: Conducting multiple analyses with different assumptions helps assess the robustness of findings.

Use of linked datasets: Combining multiple data sources (e.g., EHRs, registries, and claims data) can improve data completeness and reduce missingness-related biases1.

Ensuring Data Quality in Real-world Studies

Improving the reliability of RWE requires stringent methodologies and advanced analytical tools. Strategies to enhance data quality include:

Systematic literature reviews: Conducting thorough literature reviews ensures that RWE studies incorporate all relevant data, reducing the risk of biased conclusions2.

Artificial intelligence in healthcare: AI-driven analytics can identify patterns, clean datasets, and account for missing variables, leading to more reliable insights3.

Standardized data collection: Implementing structured reporting systems across healthcare institutions ensures greater consistency and completeness in real-world data4.

Regulatory compliance: Adhering to guidelines set by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) ensures that real-world studies meet rigorous scientific and ethical standards5.

The Role of Regulatory Compliance in RWE Reliability

To incorporate RWE into clinical decision-making, regulatory bodies have introduced stringent data governance frameworks. Ensuring compliance with Good Clinical Practice (GCP) and other regulations mitigates the risks associated with incomplete or biased data.

The FDA’s Real-World Evidence Framework establishes standards for assessing RWD quality, study design, and applicability in regulatory submissions6.

The EMA emphasizes transparency and reproducibility in RWE submissions, ensuring that studies meet the highest scientific standards7.

For example, the FDA approved Palbociclib (Ibrance) for male breast cancer based on RWE from claims and EHR data rather than traditional clinical trials8. This case highlights how high-quality RWE can inform regulatory decisions when RCTs are impractical.

Future Outlook: Combining RWE with Clinical Trials

While RCTs remain the gold standard for evaluating treatment efficacy, RWE plays a complementary role by providing insights into long-term safety, patient adherence, and economic impact. Integrating real-world data with traditional research methodologies can create a more comprehensive understanding of healthcare interventions.

Advancements in AI-driven analytics, real-time data integration, and digital health monitoring are improving the accuracy of RWE studies. Organizations are increasingly leveraging these technologies to refine data accuracy and eliminate bias9. By embracing the best practices in systematic literature review, regulatory compliance, and data validation, real-world studies can offer valuable insights that drive evidence-based healthcare decisions.

The Path Forward

RWE is a powerful tool in modern healthcare, but its reliability depends on addressing biases and ensuring data integrity. Implementing standardized methodologies, leveraging artificial intelligence, and adhering to regulatory standards can help unlock the full potential of real-world studies and effectively disseminate findings across the healthcare ecosystem.

References

Schneeweiss S. Learning from big health care data. N Engl J Med. 2014;370(23):2161-3.

Wang SV, Pinheiro S, Hua W, et al. STaRT-RWE: structured template for planning and reporting on the implementation of real-world evidence studies. BMJ 2021;372:m4856.

Rajkomar A, Dean J, Kohane I. Machine learning in medicine. N Engl J Med. 2019;380(14):1347-58.

FDA. Real-world evidence: what is it and what can it tell us? [Internet]. 2023 [cited Feb 27, 2025]. Available from: Real-World Evidence

European Medicines Agency. Real-world evidence in regulatory decision-making [Internet]. 2022 [cited Feb 27, 2025]. Available from: https://www.ema.europa.eu/en/human-regulatory/post-authorisation/real-world-evidence

US FDA. Framework for FDA’s real-world evidence program [Internet]. 2018 [cited Feb 27, 2025]. Available from: https://www.fda.gov/media/120060/download

European Medicines Agency. Guideline on good pharmacovigilance practices (GVP) [Internet]. 2021 [cited Feb 27, 2025]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-good-pharmacovigilance-practices_en.pdf

US FDA. FDA approves Ibrance for male breast cancer based on real-world evidence [Internet]. 2019 [cited Feb 27, 2025]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-ibrance-male-breast-cancer-based-real-world-evidence

Corrigan-Curay J, Sacks L, Woodcock J. Real-world evidence and regulatory decision making: where are we now? Clin Pharmacol Ther. 2018;104(5):822-9.

Contact Us – info@turacoz.com

Visit Us at – Turacoz Healthcare Solutions: Medical Communications Company

What’s Next for Medical Writing? Top Trends Shaping the Industry

What’s Next for Medical Writing? Top Trends Shaping the Industry

Our recent poll revealed that Artificial intelligence (AI) integration is anticipated to have the most significant impact on the future of medical writing. With a rapidly evolving healthcare industry, medical writers are expected to adapt to a dynamic environment shaped by technological advancements, patient-centered approaches, and globalization. This article delves into the trends that will shape medical writing in the coming years and what they mean for professionals in the field.

  1. AI Integration: Shaping the Future of Medical Writing

The poll results indicate that a significant 60% of respondents believe AI integration will play a pivotal role in medical writing. This trend is expected given the growing impact AI is already having on the field. From automating literature searches to drafting clinical study reports, AI is improving efficiency, accuracy, and productivity.

Key Contributions of AI to Medical Writing

  • Automated Content Generation: AI-powered tools like ChatGPT can draft sections of manuscripts, abstracts, and summaries. This reduces the time required for first drafts, enabling writers to focus on refining content and ensuring compliance with regulatory standards.
  • Data Analysis and Interpretation: Tools equipped with natural language processing (NLP) can extract and analyze data from clinical trials, research papers, and regulatory documents. AI simplifies complex data sets, helping writers present findings clearly and concisely.
  • Grammar Check and Translation: AI tools are increasingly being used for grammar and style checks, ensuring documents adhere to linguistic and stylistic standards. Additionally, advanced translation technologies enable seamless multilingual content creation, breaking language barriers, and facilitating global communication.

AI’s role in medical writing extends beyond automation. It enables predictive analytics and personalized content creation, offering tailored solutions for diverse audiences, including healthcare professionals, regulatory bodies, and patients.

Challenges and Opportunities

While AI offers immense benefits, it also raises concerns about data security, ethical considerations, and the potential loss of human oversight in sensitive medical communications. However, these challenges present opportunities for medical writers to upskill and collaborate with AI, enhancing their roles as content strategists and quality controllers.

  1. Evidence-based Writing: The Foundation of Credible Communication

Coming in as the second most influential trend, with 19% of the votes, evidence-based writing underscores the importance of accuracy and scientific rigor in medical communication. As healthcare decisions increasingly rely on data-driven insights, medical writers must ensure their content is rooted in robust evidence.

The Role of Evidence-based Writing

Transparency and Accountability: Evidence-based writing involves citing credible sources, ensuring transparency, and providing a clear trail of evidence supporting medical claims. This is crucial in regulatory documents, clinical trial reports, and healthcare guidelines.

Strengthening Healthcare Decisions: By presenting data from systematic reviews, meta-analyses, and clinical trials, medical writers help healthcare professionals make informed decisions. This approach supports the development of effective treatments and interventions.

Adapting to New Data Standards

The demand for evidence-based writing is expected to grow as data-sharing initiatives and open-access publishing increase. Medical writers must stay updated on evolving guidelines and best practices for integrating and presenting evidence in various formats.

  1. Patient Centricity: Putting Patients at the Center of Communication

With 17% of respondents highlighting patient-centricity as a key trend, it’s clear that the focus on patients is becoming more central in medical writing. This shift reflects a broader movement in healthcare toward empowering patients and ensuring they are active participants in their care journey.

What is Patient-centric Medical Writing?

Patient-centric medical writing involves tailoring content to meet the needs of patients, ensuring information is accessible, understandable, and relevant. This includes:

  • Simplifying Medical Jargon: Translating complex medical terminology into lay language, so patients can understand their diagnoses, treatments, and clinical trial participation.
  • Focusing on Patient Experiences: Including patient-reported outcomes and experiences in clinical trial reports and other medical documents.
  • Developing Patient Education Materials: Creating leaflets, brochures, and digital content that inform and empower patients.

The Rise of Plain Language Summaries (PLSs)

One of the most notable developments in patient-centric medical writing is the increasing use of PLS. These summaries provide a clear and concise overview of complex medical research, making it accessible to non-specialist audiences. As regulatory bodies like the European Medicines Agency (EMA) emphasize the importance of PLS, medical writers are expected to play a pivotal role in their development.

  1. Multilingual Content: Breaking Language Barriers

Though only 4% of respondents identified multilingual content as a top trend, its importance cannot be overstated. As healthcare becomes more globalized, the ability to communicate effectively across different languages and cultures is critical.

Why Multilingual Content Matters

  • Global Clinical Trials: With clinical trials conducted across multiple countries, medical writers must produce documents that cater to diverse regulatory requirements and linguistic needs.
  • Health Campaigns and Education: Multilingual content ensures that vital health information reaches diverse populations, promoting inclusivity and equity in healthcare.
  • Regulatory Submissions: In regions like the European Union, regulatory submissions often require documentation in multiple languages.

Tools and Techniques for Multilingual Medical Writing

Advancements in translation technologies, including AI-driven tools, are making multilingual medical writing more efficient. However, human oversight remains crucial to ensure cultural nuances and context are accurately conveyed.

How AI Can Support Every Trend

AI plays a pivotal role in each of these emerging trends. In evidence-based writing, AI tools can swiftly analyze vast amounts of clinical data, enabling writers to identify and cite the most relevant evidence. For patient-centricity, AI can personalize content by analyzing patient feedback and tailoring educational materials to specific needs. In the realm of multilingual content, AI-driven translation tools ensure timely and accurate communication across languages, fostering inclusivity. AI is not only a driving force in its dedicated trend but also a supportive tool that enhances the effectiveness of every other emerging aspect of medical writing.

Implications for Medical Writers

The trends identified in our poll reflect a dynamic and rapidly evolving field. To stay ahead, medical writers must adapt and expand their skill sets:

  • Technical Proficiency: Familiarity with AI tools and data analysis software will be essential as automation becomes more prevalent.
  • Continuous Learning: Keeping up-to-date with evolving guidelines, best practices, and new trends like patient-centric and evidence-based writing.
  • Cultural Competence: Understanding and respecting cultural differences will enhance the effectiveness of multilingual content.
  • Interdisciplinary Collaboration: Working closely with healthcare professionals, regulatory bodies, and patient advocacy groups to create impactful medical communications.

The Road Ahead

As we look to the future, it’s clear that medical writing will play an even more critical role in shaping healthcare communication. The integration of AI, the emphasis on evidence-based and patient-centric approaches, and the need for multilingual content will redefine the profession, offering both challenges and opportunities.

At Turacoz, we are committed to embracing these trends and equipping our team with the skills and tools to lead in this evolving field. Whether it’s leveraging AI for efficiency, adopting evidence-based methodologies, or focusing on patient-first communication, we are ready to meet the challenges of the future head-on.

For more information, reach out to us at info@turacoz.com

Wednesday, 2 April 2025

Importance of Professional Medical Writing Services in Healthcare

 

Importance of Professional Medical Writing Services in Healthcare

Medical writing involves the expertise to craft the healthcare content keeping in mind the audience you are catering to. This includes creating information for general readers seeking healthcare treatments who may not be familiar with medical terminology. For example, they might recognize terms like ‘high blood pressure’ instead of ‘hypertension’ or ‘high blood sugar level’ instead of ‘hyperglycaemia.’ Skilled medical writers transform complex medical terminology and clinical research data into accessible and easy-to-understand information for through a process known as medical communication.

Importance of Professional Medical Writing in Healthcare Content Creation

In today’s era of information and technology, professional medical writers play a crucial role in bridging the gap between complex medical information and diverse audiences. They create clear, accurate, and engaging healthcare content that enhances public awareness and education, ultimately fostering trust and engagement with healthcare organizations. Additionally, medical writers are pivotal in developing well-structured documentation to support regulatory approval processes for new treatments, ensuring adherence to strict guidelines and standards. Their expertise improves communication and drives advancements in healthcare and patient outcomes.

How Medical Communication Facilitates Regulatory Approvals?
A medical writer serves as a liaison between researchers, pharmaceutical companies, and the broader medical community. Different skill sets are required when you’re writing for a layman compared to a healthcare professional to make them understand some technical terms. The differences are mentioned below in the table.

On the other hand, when we craft professional documents for the stakeholders or regulatory agencies, we first prepare the templates having a certain style guide, and professional tone. The same document undergoes multiple quality check approvals so that not a single misplaced comma or ambiguous phrases can lead to any misunderstanding, that could compromise patient safety.

Some forms of professional medical writing include Clinical Report Writing, Regulatory writing, Scientific writing, Medical Education Writing, Health Economics and Outcomes Research (HEOR) Writing, Grant Writing, Medico-Marketing Writing, Technical Writing for Medical Devices, Editorial Services for journal publications, conference materials, poster presentations and so on.

Why Mastering Medical Writing is Crucial for Pharma Industry Success?

Failure to effectively communicate in above mentioned high-stakes documents can delay regulatory approvals, potentially leading to financial losses, wasted time, and reputational damage of the involved parties in the healthcare industry. Mastering medical writing is, therefore, an indispensable skill for anyone working in the pharma industry or about to enter the healthcare documentation writing services to ensure that no document gets stalled between agencies and research organizations.

Tuesday, 1 April 2025

**The Role of Medical Science Liaisons in Educating Physicians on Colorectal Cancer Advances**

 


Colorectal cancer (CRC) is the third most commonly diagnosed form of cancer globally and is the second most common cancer-related cause of death worldwide.1,2 This makes CRC a major public health issue due to the great economic burden it places on countries. There is significant progress in screening, diagnosis, and therapy for CRC at present; however, prognosis is poor, and there are challenges.2 With rapid advancements in treatment, staying updated on new therapeutic developments is crucial. Medical Science Liaisons (MSLs) play a vital role in bridging the gap between pharmaceutical companies and healthcare professionals (HCPs) by providing scientific expertise, facilitating medical education, and ensuring the exchange of accurate, up-to-date clinical data and therapeutic guidelines.3

The growing importance of MSLs in oncology

MSLs are highly trained scientific professionals, often with advanced degrees in medicine, pharmacy, or life sciences, and are key members of the medical Affairs teams of pharmaceutical companies.3 They serve as a critical link between the pharmaceutical industry and the medical community, aiding in informed decision-making, fostering collaborations, and enhancing patient care.4

In oncology, where the treatment landscape evolves rapidly, MSLs play a key role in equipping physicians with the knowledge necessary to optimize patient care.

How MSLs keep physicians updated on CRC research

Colorectal cancer treatment has witnessed major advancements in recent years, including targeted therapies, immunotherapies, precision medicine and biomarker-based treatment, antibody-drug conjugate therapy, and novel chemotherapy.5 MSLs ensure that physicians stay informed on these innovations in the following ways:

  1. Providing clinical insights

MSLs interpret and communicate complex clinical trial data, helping physicians understand the latest scientific breakthroughs and how new therapies compare with existing treatments in terms of efficacy, safety, and patient outcomes.6 Thus, MSLs serve as a bridge between the industry and HCPs or key opinion leaders (KOLs), facilitating a two-way exchange of scientific and clinical information. By keeping KOLs informed about the latest industry developments, MSLs help save their valuable time.4

  1. Explaining mechanisms of action

With the rise of precision medicine, understanding the molecular mechanisms of novel drugs is crucial. MSLs educate physicians on how therapies, such as immune checkpoint inhibitors, monoclonal antibodies, and combination regimen, work at a molecular level.

  1. Navigating treatment guidelines

Organizations like the National Comprehensive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO) frequently update treatment guidelines. MSLs assist physicians in integrating these changes into clinical practice, ensuring adherence to the most recent guidelines.

  1. Facilitating real-world data insights

Beyond clinical trials, real-world evidence plays a crucial role in assessing long-term treatment effectiveness and improving medical treatment.7 MSLs provide valuable insights into patient responses, adverse event management, and emerging real-world trends.

How MSLs bridge research and clinical practice

One of the major challenges in oncology is translating scientific research into practical, patient-centered care. MSLs address this challenge by:

  1. Conducting peer-to-peer educational programs

MSLs organize advisory boards, roundtable discussions, and one-on-one meetings with KOLs to discuss recent advancements in the therapeutic area and their implications for clinical practice. MSLs gather insights from KOLs and help in guiding research and product development for pharmaceutical and biotechnology companies.

  1. Facilitating clinical trials

Oncologists often collaborate with pharmaceutical companies to enroll patients in clinical trials. MSLs help identify suitable studies, clarify eligibility criteria, and provide trial-related updates to oncologists.

  1. Providing medical education resources

From whitepapers to webinars, MSLs curate educational content tailored to the needs of oncologists, ensuring they have access to reliable and relevant information.

  1. Fostering multidisciplinary collaboration in CRC treatment

Colorectal cancer management requires a multidisciplinary approach, involving medical specialists such as medical oncologists, surgical oncologists, radiologists, gastroenterologists, radiation oncologists, and pathologists.8 MSLs play a crucial role in fostering collaboration among these specialties by:

  • Encouraging interdisciplinary discussions on treatment sequencing and combination strategies.
  • Addressing concerns related to emerging therapies, such as side effect management and patient selection criteria.
  • Ensuring consistent communication between pharmaceutical companies and medical institutions to align treatment advancements with real-world patient needs.

Call to action: Recognizing the impact of MSLs in oncology

The Colorectal Cancer Awareness Month serves as a timely reminder to recognize and appreciate the invaluable contributions of MSLs in the fight against CRC. Turacoz proudly acknowledges and values the critical role MSLs play in advancing care and driving impact in the battle against CRC. Their expertise not only advances physician education but also enhances patient outcomes by ensuring that the latest medical innovations are seamlessly integrated into clinical practice.

By championing the role of MSLs, we can bridge the gap between research and real-world care, ensuring every patient with CRC receives the best treatment possible.

References

  1. Klimeck L, Heisser T, Hoffmeister M, et al. Colorectal cancer: A health and economic problem. Best Practice & Research Clinical Gastroenterology. 2023 Oct 1;66:101839.
  2. Fadlallah H, El Masri J, Fakhereddine H, et al. Colorectal cancer: Recent advances in management and treatment. World journal of clinical oncology. 2024 Sep 24;15(9):1136.
  3. Chen J, Burns G, Kelly C, Vanderhoef D, Johnson J. Medical Science Liaisons: A Guide for Advanced Practice Registered Nurses. The Journal for Nurse Practitioners. 2024 Nov 1;20(10):105211.
  4. García García C, Riosalido Montero M, Sastre V, González del Castillo A, Matesanz Marín A. The medical science liaison role in Spain: Opinion of the commercial department personnel. Therapeutic Innovation & Regulatory Science. 2023 Sep;57(5):1030-9.
  5. Alese OB, Wu C, Chapin WJ, et al. Update on emerging therapies for advanced colorectal cancer. American Society of Clinical Oncology Educational Book. 2023 May;43:e389574.
  6. Theron P, Britland M, Holder D, Ikeda Y, Rewers RF, Tiku A. Promoting best practices for medical science liaisons position statement from the APPA, IFAPP, MAPS and MSLS. Therapeutic Innovation & Regulatory Science. 2021 Nov;55:1139-44.
  7. Moss B, Goodall EA, Maravic Z, et al. Real-world evidence research in metastatic colorectal cancer: raising awareness of the need for patient contributions. Future Oncology. 2023 Aug 1;19(26):1811-23.
  8. Sievers CK, Kratz JD, Zurbriggen LD, et al. The multidisciplinary management of colorectal cancer: present and future paradigms. Clinics in colon and rectal surgery. 2016 Sep;29(03):232-8.

Thursday, 23 January 2020

Advisory Board: Option or Compulsion



The privilege of having access to top-notch advice can increase the odds of success for an already established business and even for a startup. To achieve this, increased attention is being paid to advisory boards (1). Advisory board is a committee or group of business executives who are appointed by the owner or the management of an organization to provide leadership, support, and constructive feedback as well as providing recommendations on specific areas (2).

Selection of members of the advisory board is based on the expertise needed or voids needed to be filled within an organization. For example, an organization can hire a lawyer for legal matters, a public relation executive for branding and marketing purposes, an industry specialist for in depth business knowledge, and/or an investor for fundraising advice (3). Unlike the traditional board of directors, members of the advisory boards have no powers and obligations (4). The President or CEO of an organization typically reports to the board of directors, whereas, the instituted advisory board serves as an advocate, supporter, and resource for the president and/or CEO (5).

Although their influence on the management cannot be sidelined but they are never really involved in the decision making process and are not entitled to impose any obligations on the management of the organization (4).

Advisory board members are appointed under the following criteria (4):
  • Do not represent owners and shareholders 
  • Typically appointed by the managing director of the company 
  • Functions independently without any obligations 
  • Provide advice and assistance to the managing director 
  • Possess versatility in the composition 
  • Do not represent replacement to an official statutory board
  • Never takes part in decision making process 
  • A reservoir of business intelligence and insight due to experience.  


Depending upon the requirements of an organization, advisory board can be categorized as (5):  
  • Informal advisory board: Organizations with limited budget usually have this type of an advisory board. These boards typically involve a group of volunteers with a very ad‑hoc style of discussion. Having such advisory boards can produce positive outcomes specially for the businesses that are in their germinal stage.
  • Formalized advisory board:  It is recognized by having a presence of an independent chair, a charter, minutes and annual impact measurement. Primarily, this type of advisory board consists of two internal directors, a Certified Chair, and two external advisors chosen specifically to fulfill the priorities included in the charter. Meetings are held on a quarterly basis, whereas the chair and directors meet more frequently. 
  • Formal project advisory boardThis type of advisory board is instituted with some specific purpose and for a fixed period of time which could range from 3 to 18 months.
  • Formal corporatized advisory board: This type of advisory board is somewhat similar to the formal project advisory board, in an organization where governance board is already in place. The charter in this type of board usually expresses the reporting mechanisms and where it stands in relation to the already established governance board. Multinational operations, commercialization, and innovation typically uses this corporatized board.
Although advisory boards are flexible in their composition, it is of great importance to provide a good infrastructure to the advisory boards, so as to make them work effectively. Some of the considerations while establishing an advisory board might include (6):
  • First is to determine the mandate of the board. 
  • Mandate should explicitly state the roles, responsibilities, and target the areas to be advised.
  • Develop policies on how deliberations of the board would take place. 
  • To have minutes of the meeting in order to confirm compliance of the advisory board with the mandate. 
  • Organizations should have it on their websites the relationship that exist between the involved parties.
  • There should be a formal agreement between the advisory board members and the organization.  
An advisory board could prove beneficial to a business or even to a startup, especially in situations where the owners do not possess much experience or intent to expand their knowledge base surrounding the business (7). In addition to this, an advisory board could provide an organization with the following advantages (8): 
  • Increased credibilityWith the help of an advisory board, a business/business owner can help increase legitimacy in the marketplace.
  • A bigger networkWith members from varied disciplines and with vast experience, advisory boards help organizations in expanding their network. For example, suggesting a vendor or selecting a new employee. 
  • Focus on the futureWhile the organization is dealing with day-to-day operations, advisory board remain focused on future prospects for the organization.

Despite many advantages that an advisory board has to offer, it does have some concerns associated with it. One of the most important one is that it has no legal responsibility which might result in generating an advice which may prove to be unsafe for the business (7).  Instituting an advisory board may demand personnel and organizational investment (9). The members of the advisory board are usually required to work at little or no compensation which would result in indifference and/or lack of commitment towards the organization by the members of advisory board (7). It is quite common for an individual to be on a board with a different organization at the same time which can create a conflict of interest (7). 

While an advisory board does poses potential to provide a path for a superior corporate governance (1), it is of great importance to get the purpose fulfilled by instituting an effective and productive advisory board for an organization. Realizing the needs and having a target set is what makes an organization look for members to be on the board of an advisory panel. Only if managed efficiently, advisory boards can do wonders, if not, it can hamper the growth and reputation of the organization in the market.

We at Turacoz Healthcare Solution are equipped with expert level professionals for advisory boards and conference coverage. To read more about the services we provide, click here.

If you have any queries, email us at hello@turacoz.in 

Tuesday, 3 December 2019

Diabetes: Types, Symptoms and Treatment




According to statistics by the WHO, “The number of people with diabetes has risen from 108 million in 1980 to 422 million in 2014.” Also, “In 2016, an estimated 1.6 million deaths were directly caused by diabetes. Another 2.2 million deaths were attributable to high blood glucose in 2012.”

Diabetes is a chronic, metabolic disease in which the body does not properly process glucose in blood for use as energy. This causes increased sugar level in the blood, eventually resulting in heart disease, blindness, kidney failure, and lower-extremity amputations. In 2019, Approximately 463 million adults (20-79 years) are presently living with diabetes and is expected to touch 700 million by 2045. In India, about 73 million people suffer from diabetes, and this figure is likely to go up to 80 million by 2025, making it the 'Diabetes Capital' of the world. Presently, diabetes is the seventh leading cause of death worldwide.

Diabetes can be classified into: type 1 diabetes caused due to autoimmune β-cell destruction of insulin producing pancreas, leading to absolute insulin deficiency), type 2 diabetes manifested by insulin resistance followed by relative deficiency in insulin secretion, Gestational diabetes mellitus diagnosed in the second or third trimester of pregnancy, specific types of such as neonatal diabetes and maturity-onset diabetes of the young [MODY]), disease of pancreas such as cystic fibrosis and pancreatitis, and drug- or chemical-induced diabetes. In addition, over secretion insulin antagonistic hormones (cortisol, glucagon, etc.) and certain viral infection (rubella, coxsackievirus B, cytomegalovirus, adenovirus, and mumps) also causes diabetes.

Diagnostic criteria for Diabetes

  • Fasting blood glucose (FPG, no calorific intake for 8 hours) ≥126 mg/dL/7.0 mmol/L) or,
  • Plasma glucose ≥200 mg/dL/11.1 mmol/L) after 2h of oral glucose load containing the equivalent of 75-g anhydrous glucose dissolved in water or,
  • Glycated hemoglobin (HbA1C) ≥6.5%/48 mmol/mol or,
  • A random plasma glucose ≥200 mg/Dl/11.1 mmol/L).

Symptoms of diabetes:

  • Urinating often
  • The feeling of constant thirsty
  • Extreme fatigue
  • Blurry vision 
  • Cuts/bruises that heal slowly 
  • Weight loss—even though you are eating constantly (type 1) 
  • Tingling, pain, or numbness in the hands/feet (type 2)

Risk of diabetes 

Prediabetics are usually referred to individuals whose glucose levels are towards upper limit of the normal range. Prediabetes is usually associated with obesity, dyslipidemia, cardiovascular diseases and hypertension. The ranges for the prediabetes are: 
  • HbA1C level: ≥5.7% but <6.4%/39–47 mmol/mol 
  • Fasting Plasma Glucose: 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) 
  • 2-h plasma glucose (OGTT): 140 mg/dL (7.8 mmol/L) to 199 mg/Dl

At least annual monitoring for the development of type 2 diabetes in those with prediabetes is suggested
Metformin therapy for prevention of type 2 diabetes should be considered in those with prediabetes, especially for those with BMI ≥35 kg/m2, those aged <60 years, and women with prior gestational diabetes mellitus

Treatment

People with type 1 diabetes should be treated with:  
  • Multiple daily injections of prandial and basal insulin, or continuous subcutaneous insulin infusion (CSII).
  • Knowledge of patients on matching prandial insulin doses to carbohydrate intake, premeal blood glucose levels, and anticipated physical activity. 

Pharmacologic Therapy for Type 2 Diabetes: 

  • Metformin is the preferred initial pharmacologic agent for the treatment of type 2 diabetes and continued unless it shows any intolerable side effect. Other agents, including insulin can be added if needed.
  • Periodic measurement of vitamin B12 levels should be considered in metformin-treated patients, especially in those with anemia or peripheral neuropathy. 
  • A choice of pharmacologic agents should be based associated comorbidities (atherosclerotic cardiovascular disease, heart failure, chronic kidney disease), hypoglycemia risk, impact on weight, cost, etc.
  • Glucagon-like peptide 1 receptor are preferable to patients over insulin, requiring a greater glucose-lowering effect.
  • The medication regimen should be reevaluated at regular intervals (every 3–6 months).

Recent challenges and developments

About 65 million people with type 2 diabetes need insulin, but only half of them can afford it. Insulin is required to all type 1 diabetics. Data from 24 countries showed that access to human insulin and analogue insulin at health center is only 61% and 5% respectively. In high income countries people often ration insulin which can be deadly for people who do not get the right quantity of the medicine 

The World Health Organization (WHO) on 13 November 2019,  announced the start of a pilot program to prequalify human insulin to increase treatment for diabetes in low- and middle-income countries.

FDA on September 20, 2019, approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise.

Lifestyle Interventions

Diabetes Prevention Program (DPP) recommends patients to achieve and maintain 7% loss of initial body weight and increase moderate-intensity physical activity (such as brisk walking) to at least 150 min/week. IDF recommends physical activity at least between three to five days a week, for a minimum of 30-45 minutes. 

  • Choosing water, coffee or tea instead of fruit juice, soda, or other sugar sweetened beverages.
  • Eating at least three servings of vegetable every day, including green leafy vegetables.
  • Eating up to three servings of fresh fruit every day.
  • Choosing nuts, a piece of fresh fruit, or unsweetened yoghurt for a snack.
  • Limiting alcohol intake to a maximum of two standard drinks per day.
  • Choosing lean cuts of white meat, poultry or seafood instead of red or processed meat.
  • Choosing peanut butter instead of chocolate spread or jam.
  • Choosing whole-grain bread, rice, or pasta instead of white bread, rice, or pasta.
  • Choosing unsaturated fats (olive oil, canola oil, corn oil, or sunflower oil) instead of saturated fats (butter, ghee, animal fat, coconut oil or palm oil.

Diabetes in smart phone applications

Few popular mobile applications available in android and iPhone, that support diabetes management are:


Figure 1: Natural remedies that can make some difference 

The herbs and plant derivatives listed below are used by native people in the treatment of diabetes, in the regions in which they grow: 

  • Allium 
  • Bauhinia forficata and Myrcia uniflora found in south America 
  • Coccinia Indica found in Indian subcontinent 
  • Ficus carica found in Spain and south-western Europe
  • American GINSENG
  • Gymnema sylvestre found in southern and central India, used in Ayurveda
  • Momordica charantia, some areas of Asia, India, Africa and South America
  • Ocimum sanctum is used in Ayurveda
  • Opuntia streptacantha used by people of Mexican desert
  • Silibum marianum

However, all these herbs and home remedies have limited evidence for diabetes control. It should be used as a complementary along with the mainstream treatment and under licensed medical practitioner.

Future hope on diabetes treatment 

Type 1 diabetes: 

Replacing missing cells with cell therapy 

Diabetes Research Institute in the US is developing a bioengineered mini-organ where insulin-producing cells are encapsulated within a protective barrier. In 2016, the institute announced that the first patient in Europe treated with this approach in an ongoing phase I/II trial no longer requires insulin therapy. A similar device is made by US based company Viacyte and this is also under clinical trial.
The Belgian company, Orgenesis and UK based Islexa is working on transforming patient’s liver/pancreas respectively into insulin-producing cells to avoid the issues of sourcing cells from donors.
Sanofi, also a big name in diabetes, is working with the German Evotec in a beta cell replacement therapy for diabetics.

Attacking the origin with immunotherapy

Imcyse, a Belgian company is running a clinical trial with an immunotherapy designed to stop type 1 diabetes by specifically killing the immune cells that destroy the pancreas.

ActoBio Therapeutics is now running a phase I/II trial with to stop the progression of type 1 diabetes by cheese-producing bacteria to deliver two drugs that stimulate regulatory T cells to instruct the immune system not to attack insulin-producing cells.

Type 2 diabetes:
  • Stimulating insulin production 
  • Development of glucagon-like peptide (GLP)-1 receptor agonists to stop glucagon production
  • Targeting the microbiome 

An unbalanced and less microbiome composition has been found in patients with diabetes. Fecal transplants, used to transfer the microbiome of a healthy person to the gut of one with diabetes, can result in a short-term improvement of insulin resistance in obese patients with type 2 diabetes.

The needle-free revolution

Devices like GlucoTrack, GlucoSense, MediWise can measure glucose using electromagnetic waves, laser like and radio wave respectively
Researchers are already anticipating about microchips that can diagnose diabetes type 1 before the symptoms appear or nanorobots traveling in the bloodstream while they measure glucose and deliver insulin.

Turacoz Healthcare Solution is committed to raise awareness about diabetes managementprevention and educating people so as to make them aware of this chronic disease. We urge the people to eat healthy and exercise daily. #FightDiabetes

If you have any queries, email us at hello@turacoz.in