RWD Vs RCT?
COMPLEMENTARY NOT CONTRADICTORY
Authors: Genpro RWE/RWD consultation group.
EMA EMPHASISES IN A PRESS-RELEASE DATED 26 MAY 2020 THAT REAL WORLD DATA CAN COME TO RESCUE TO FILL VOIDS IN COVID-19 UNDERSTANDING.
“For observational studies of real world data in COVID-19, EMA calls for transparency for protocols and results, and collaboration between researchers, to ensure high-quality, powerful studies. High-quality observational research of real world data collected during the pandemic can be an important complement to the results of randomised clinical trials in providing evidence on the safety and effectiveness of vaccines and treatments for COVID-19. Such research is also critical to understand how exposure to certain medicines can affect the risk or the severity of infection with the virus.”
There have been recent criticisms about poorly designed COVID-19 clinical and the limitations thereof. But researchers and pharma companies face challenges on multiple fronts. The disease conditions and the pathophysiology around COVID-19 is not fully understood. In a JAMA editorial published in early May 2020, the experts reiterated the need for better COVID-19 RCT designs. These designs should substantiate the findings and avoid ambiguous results due to design or trial population size limitations1.
Earlier on 19th May 2020, FDA released COVID-19 RWD Data Harmonization Project to harmonize a list of COVID-19 data elements with several Common Data Models (CDMs) and open standards. This was a bold step to harmonize and facilitate the use of RWD to harness the power of data for enhancing research and regulatory outcomes.
Prior to that in early April 2020, EFPIA, one of the leading organisations of pharmaceutical industry, shared a view that COVID-19 has provided thrust to the Regulatory Road for adopting Innovation3. Due to the acute need of disruptive methods in patient enrolment, study designs and study operation, the regulatory systems need to be flexible and open to innovative ideas. According to EFPIA, data collected in medical practice would not only inform health systems and their resources, but also inform development of medicines. One of the key viewpoints shared was to
“Allow greater use of data from real world use of treatment”
Another important limitation around current pandemic due to SARS-CoV-2 infections is limited understanding of the disease profile per se and changing hypothesis around why certain populations are at higher risks or why mortality rates are different amongst various geographies or ethnicities. Epidemiology of COVID-19 is not fully understood which is limiting a lot of further decisions at regulatory or health care delivery fronts.
One of the solutions to fill such gaps is to run well-designed and adequately powered observational studies, says EMA’s press release4. The investigators in observational studies just observe individuals (patients or healthy population) without manipulation or intervention and hence they are thought to have unique advantages of avoiding bias or have more balanced hypotheses.
Recently Genpro Research’s RWE group designed a solution using retrospective study on large patient databases for a major pharmaceutical company to fill the ‘gaps’ they identified, and the solution ultimately helped in decision making at a very high level.
Reach out to firstname.lastname@example.org to know about RWE/RWD solutions integrated with sophisticated analytics to solve any questions you may have or see how our proactive solutions can help you to design better regulatory and development strategy.
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- Bauchner H, Fontanarosa PB. Randomized Clinical Trials and COVID-19: Managing Expectations. JAMA. Published online May 04, 2020. doi:10.1001/jama.2020.8115
- FDA RWD harmonization project: https://www.fda.gov/drugs/coronavirus-covid-19-drugs/covid-19-real-world-data-rwd-data-elements-harmonization-project Last Accessed on 27 May 2020.
- EFPIA view on innovations in the era of pandemic: https://www.efpia.eu/news-events/the-efpia-view/blog-articles/the-covid-19-regulatory-road-to-innovation/ Last Accessed on 27 May 2020.
- EMA calls for high-quality observational research in context of COVID-19: https://www.ema.europa.eu/en/news/ema-calls-high-quality-observational-research-context-covid-19 Last Accessed on 27 May 2020.
Tags: #GenproRsearch #RWE #RWD #StrategicSolution #ObservationalStudies #EMA #USFDA #COVID19