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.

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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

 

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.

**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.