The Evolving Relationship Between Real World Data and Clinical Trials with Nancy Dreyer and C.K. Wang
In this episode of Real World Talk, host Zoe Li talks to Nancy Dreyer, Chief Scientific Officer of IQVIA, and COTA’s own Chief Medical Officer, Dr. C.K. Wang. They discuss the interactions between real world data and clinical trials, and how the two approaches can complement each other.
[00:29] Introductions — Zoe Li introduces Nancy Dreyer, Ph.D, Chief Scientific Officer of IQVIA, and COTA’s Chief Medical Officer Dr. CK Wang, and asks why the Lancet recently had to retract a study about the use of hydroxychloroquine in the treatment of COVID-19.
[02:03] Insufficient information — Nancy Dreyer explains that reviewers who are used to clinical trials struggle to assess the quality of real world data, and that the authors failed to provide enough information on the provenance of their data.
[7:20] Trials and errors — Clinicians tend to be skeptical of real world data, but errors like this — and even fraud — happen in clinical trial settings too.
[11:57] Clear information — Dr. Wang explains that more transparency around data would make it easier for different labs to work together. Nancy Dreyer says that clearly showing the provenance of data is key to proving that it’s high quality and trustworthy.
[15:38] COVID-19 situation — As our understanding of COVID-19 continues to evolve, it’s the perfect example of how real world data and clinical trials can be used in conjunction to achieve fast and targeted research.
[18:30] Cancer drugs — Dr. Wang says that combining real world data and clinical trials also makes sense in cancer treatment, as the FDA is rapidly approving new drugs.
[20:30] Teaser evidence — Real world data can give manufacturers a preview of areas of interest, and provide an economic incentive to fund further research.
[24:09] Context matters —- The impact of real world data depends on the context: the bigger the effect you can prove, the more likely it will lead to a trial or more funding.
[26:24] FDA guidelines — The FDA is working to draft guidelines for the use of real world evidence by the end of 2021, looking at factors including structure, provenance, curation and integration.
[27:53] Importance of curation — Nancy Dreyer works with big sports leagues to record injuries, and she’s found that curation is a key component to ensuring accurate, useful data.
[29:40] Patient welfare — As well as considering the clinical uses for real world data, Dr. Wang wants to use it to improve patient experiences.
Real world data provides fast insights into rapidly developing situations. Whether that’s around COVID-19 or new cancer treatments, looking at real world data can help manufacturers and clinical scientists make decisions about which research to fund and where to focus future investigations.
More transparency and clarity is needed when it comes to the provenance of real world data. Clinicians are right to be skeptical of data that doesn’t have a clear provenance, and of authors who don’t explain their collection methods and analytical approaches. Knowing where data has come from to a very specific degree makes it more trustworthy and easier to share.
Manufacturers are most interested in attention-grabbing results. Real world evidence that shows dramatic statistical significance makes more of an impact on manufacturers and clinicians. This explains why real world data studies into chronic conditions tend to make less headway.