Unlocking the Potential of Real-World Evidence (RWE) in Clinical Trials

Unlocking the Potential of Real-World Evidence (RWE) in Clinical Trials: A Guide for Sponsors

Introduction

RWE studies and randomised controlled trials (RCTs) should ideally work together to further explore and offer deeper insights into product effectiveness and safety in particular patient subgroups, such as those with comorbidities.

Overview of Real-World Evidence in Clinical Studies

Real world evidence 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 trials. Actually, RWE is used by the FDA to help with decision-making about approval of drugs or label modifications.

This is noteworthy because a growing number of medications are being licensed on the basis of RWE rather than the outcomes of clinical trials. A primary reason for this is that organisations struggle to carry out extensive, long-term research on actual patients with real diseases and subsequently publish their findings.

What is real-world evidence (RWE)?

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” under Section 505F(b) of the FD&C Act (21 U.S.C. 355g(b)).

Real-World Evidence

Fig : Real-World Evidence

Any pertinent patient-level data not gathered through a standard clinical trial, which is typically randomised, is referred to as real-world data and real-world evidence. The differences in the data obtained from randomised clinical trials, real-world data and real-world evidence is as follows:

	Clinical Trials	Real world data (RWD)	Real world evidence (RWE)
Overview	Clinical trials are investigations conducted to evaluate a medicinal, surgical, or behavioural intervention.	Regularly gathered from a range of sources about the state of health of patients and/or the provision of healthcare.	Clinical data regarding the application and possible advantages or disadvantages of a medicinal product.
Source	Results of trials conducted on humans.	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.

Benefits of Real-World Evidence for Sponsors

Understanding the true efficacy and safety profile of the product is made easier by utilising real world data and evidence to bridge the gap left by randomised clinical trials (RCTs) in current clinical understanding. Some of the benefits of clinical trials in the medical field using real world evidence include:

Exploring various facets of health and illness, including epidemiology, disease burden, treatment patterns, safety, treatment outcomes, long-term outcomes, and patient-reported outcomes like satisfaction, quality of life, medication adherence, and patient experience.
Obtaining deep insights into the financial aspects of a medical product.
Reduction of trial time and associated costs in early stages of drug development.
Enhancing regulatory and clinical decision making, such as the approval of medicinal items, are increasingly being supported by RWE.
Improving the way RCTs are conducted.

At each stage of clinical trials, real world evidence provides various advantages for sponsors. This includes:

Prior to product development	At or after marketing authorization	After launch of product
Prevalence, incidence, and unmet medical need of natural history of disease	Insights into early and/or long-term clinical experience	Health outcomes and comparative effectiveness & support for increasing the number of indications
Recognizing the existing service infrastructure and whether any modifications are necessary to provide the new medication	Prospective research on safety surveillance	Compliance with product labels or treatment guidelines
Generating hypotheses for prospective trials.	Evidence to show improved health outcomes, resource conservation, and patient acceptability	Recognizing inadequate dosage or course of treatment
	Identification of undiagnosed/untreated patients (or “unmet need”).	Monitoring safety, particularly unusual or rare adverse reactions.

How can CliniExperts help?

With more than ten years of experience in the industry, CliniExperts is a 360-degree comprehensive clinical studies solutions provider. It is a one stop solution service and ensures a simple, and hassle-free process to obtain the required permissions and supporting documentation for obtaining the best clinical research services in India.

Obtaining the required licences and approvals for your products is made simple by the highly skilled team and extensive industry networks. With the help of CliniExperts you are assured a smooth experience in receiving necessary licences and approvals for your products.

Summary

The FDA has a long history of monitoring and assessing the post market safety of authorised medications by using real-world data (RWD) and real-world evidence (RWE).
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.
Numerous benefits of RWE studies include enhanced external validity, higher generalizability, better comprehension of the long-term effects of treatment, in-depth examination of the product/treatment, and faster research findings and knowledge.

Conclusion

A valuable resource for helping doctors and patients make educated treatment decisions is real-world evidence. It is important to keep in mind that RWE can frequently complement and enhance clinical trials to further develop therapeutic understanding and research.

References

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
FRAMEWORK FOR FDA’S REAL WORLD EVIDENCE PROGRAM [Internet]. www.fda.gov. 2018.
Available from: https://www.fda.gov/media/120060/download?attachment
Clinical trials [Internet]. WHO. 2023.
Available from: https://www.who.int/health-topics/clinical-trials#tab=tab_1
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/
Bhatt A. Conducting real-world evidence studies in India. Perspectives in Clinical Research [Internet]. 2019 [cited 2019 May 12];10(2):51.
Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6463503/

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Unlocking the Potential of Real-World Evidence (RWE) in Clinical Trials: A Guide for Sponsors

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