Importance of Real-World Evidence (RWE) in Clinical Trial Solutions

Understanding the Importance of Real-World Evidence (RWE) in Clinical Trial Solutions

Introduction

The process of obtaining data on a treatment’s actual effectiveness from medical records and other sources is known as real-world evidence or RWE. RWE can help researchers make more informed decisions about which therapies to make available by helping them comprehend practical results that go beyond what they see in clinical studies. Moreover, RWE is used by the FDA to help with decision-making about approval of drugs or label modifications.

What is real world evidence (RWE)?

Under Section 505F(b) of the FD&C Act (21 U.S.C. 355g(b)), real world evidence (RWE) is defined as “data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than traditional clinical trials.

This can help in clinical development, lower medical risks, enhance patient satisfaction, and satisfy payer and regulatory obligations. RWE refers to clinical evidence about the application and possible advantages or disadvantages of a medical procedure or product.

Real-world data (RWD) is transformed, analysed, and interpreted before being used as a basis for RWE, which can then be applied to payer, policy, clinical, or other choices.

Difference between real world evidence and real-world data in clinical studies

	Real world data (RWD)	Real world evidence (RWE)
Definition	Data gathered from a variety of sources about the health of patients and/or the provision of healthcare.	Clinical data regarding the application and possible advantages or disadvantages of a medicinal product.
Source	Registries, collections of electronic health records (EHRs), administrative and medical claims databases can be used for data collection.	Obtained from an analysis of real-world data.

Is real world evidence in clinical trials necessary?

RWE supports inclusion/exclusion criteria early in the clinical trial planning phase by assisting in the identification of suitable patient populations and by using RWD sources.

RWE fosters creative experimentation. Phase II/III hybrid trials can be carried out through the integration of site-based data with registry and electronic health record data. RWE also uses historical or external controls to improve results from single-arm experiments. It also makes it possible to establish external control arms for a more accurate comparison with patients receiving active treatment. Thus, RWE can be a real game-changer in clinical studies.

Importance of real-world evidence in Clinical Trial Solutions

Real world evidence refers to clinical evidence about the application and possible advantages or disadvantages of a medical procedure or product. Value is differentiated by RWE from the industry standard of care, similar items already on the market, and new competitors.

The main importance of real-world evidence in clinical trial solutions include:

Robust technology: The real-world evidence is obtained from an analysis of real-world data (Registries, collections of electronic health records (EHRs), administrative and medical claims databases are used for data collection)
Helps in drug approval: The US Food and Drug Administration (FDA) is willing to use real-world evidence (RWE) for drug approval. RWE helps companies satisfy regulatory standards by facilitating timely and informed decision-making, which is beneficial for drug approval. RWD improves the process from integrated product development planning to regulatory submission, health authority involvement, and regulatory approval. Additionally, evidence-based outcomes research and health economic evaluation are used to show its usefulness.
Supports research in larger populations: We can gain a better understanding of illness situations, patient experiences, and the effects of medicines in larger populations by looking at how pharmaceuticals function in these settings.

Applications of Real-World Evidence

Fig : Applications of Real-World Evidence

Summary

CliniExperts is a well-established, 360-degree, regulatory consultants’ agency who have many years of industry expertise for clinical trials in India.

Real-world evidence can provide important insights and advance knowledge of patient experiences and results.
Real-world evidence has been utilised to support regulatory choices, influence designs of clinical studies, enhance clinical guidelines and disease understanding, aid financial conversations and reimbursement decisions, and encourage new applications for already-marketed medicines.
Real-world evidence can supplement and improve knowledge obtained from clinical trials.

Conclusion

In India, CliniExperts is a decade long established regulatory expert offering full-service, 360-degree clinical trial solutions. It can be difficult to navigate the complicated path from the conception to the approval of a product, particularly when faced with strict rules surrounding a clinical trial of a medical device or therapy. We provide an affordable way to expedite this procedure. We give you a strategic edge because of our extensive knowledge of the complexities involved in development, testing, approval, manufacturing, commercialization, and post-marketing surveillance. Count on us to streamline your clinical research services in India to triumph.

Numerous benefits of RWE studies include enhanced external validity, higher generalizability, better comprehension of the treatments’ long-term effects, lower costs associated with drug approval, in-depth examination of the product/treatment in specific patient subgroups, such as those with comorbidities, and faster research findings and knowledge. RWE studies and randomised controlled trials (RCTs) should therefore ideally work together to further explore and offer deeper insights into product effectiveness and safety in particular patient subgroups.

References

FRAMEWORK FOR FDA’S REAL WORLD EVIDENCE PROGRAM [Internet]. www.fda.gov. 2018. Available from: https://www.fda.gov/media/120060/download?attachment
Real-World Evidence [Internet]. U.S. Food and Drug Administration. 2019.
Available from: https://www.fda.gov/science-research/science-and-research-special-topics/real-world-evidence
Dang A. Real-World Evidence: A Primer. Pharmaceutical Medicine. 2023 Jan;37(1):25–36.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9815890/
Purpura CA, Garry EM, Honig N, Case A, Rassen JA. The Role of Real‐World Evidence in FDA‐Approved New Drug and Biologics License Applications. Clinical Pharmacology and Therapeutics [Internet]. 2022 Jan 1;111(1):135–44.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9299054/
Pharma Regulatory Consultants, Regulatory Affairs Services in India -CliniExperts [Internet]. cliniexperts.com.
Available from: https://cliniexperts.com/

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