Daubert v. Merrell Dow Pharmaceuticals, Inc. set legal precedent in the early 1990s regarding the admission of experts and set the standard for courts to weed out pseudoscience while still lifting the requirements of general acceptance imposed by Frye.
Stat finds that, as a result of a partnership with credit reporting company Experian, CRO IQVIA has linked health record data on up to 120 million American's to credit reports and is sharing "deidentified" data using tokens. However, as Stat notes, Iqvia "refuses to share a detailed accounting" with the parties with whom it is sharing information and that the data may be used for targeted advertising and is not protected by HIPAA.
CRO Parexel discusses the challenges a CRO faces including working of new therapies with a focus on oncology and cell therapies. Challenges including toxicity, handling and differences in working outside of the US and country-specific requirements. The video then discusses FDA regulations and Parexel talks about how the FDA dose optimization requirement is impacting trials. The video then focuses on the impact of the Inflation Reduction Act and how that is impacting Sponsor research priorities and what drugs to research along with how Parexel can meet FDA diversity guidance. Finally, Parexel discusses trial designs and how to use Accelerated Approval to speed up drug approval.
The University of Pennsylvania law school held a panel looking at the effects of the recent Dobbs v. Jackson Women's Health Organization decision on a range of topics impacting public health, but with a specific focus on clinical trials. Professor Patti Zettler of The Ohio State University Moritz College of Law discussed the "Ripple Effect" that Dobbs could have on everything from clinical trials involving pregnant people but also with factors that are important in decentralized clinical trials such as digital health devices and related privacy implications. Professor Zettler also specifically focused on the issue of Federal preemption and the Supremacy Clause, and how this might impact the FDA's regulation of Mifepristone access (and access to things such as IUDs e.g) as States criminalize abortion. Another panelist, Greer Donley Associate Professor of Law University of Pittsburgh School of Law, touched on some of the ways that Dobbs is shaping health law, such as the need for more lawyers familiar in postal law issues, which will also likely be of interest as virtual clinical trial vendors attempt to reach patients in remote communities.
PDUFA VII (Prescription Drug User Fee Act) was recently reauthorized as as part of the FDA User Fee Reauthorization Act of 2022 signed into law in September 2022. This video from the FDA looks at the impact of PDUFA VII on Complex Innovative Trial Designs (CID) including novel designs such as Master Protocol, simulations, the use of Bayesian methods and touches on how to "leverage data" for rare disease treatments. The video then looks at the CID and Master Protocol for the PREVAIL II Ebola clinical trial to evaluate multiple therapies under a Master Protocol.
Andrew Titman from Lancaster University discusses the The AGILE Clinical Trial; a Phase 1/Phase 2a adaptive clinical trial testing new drugs aimed at treating COVID-19 including (as of the time of the video) Molnupiravir (Legervrio) and Sotrovimab (marketed as Xevudy, from GlaxoSmithKline and Vir Biotechnology). The video looks at the difference between the AGILE trial (a platform clinical trial) and Master Protocol Clinical Trials and how both statistical methods help recruit patients into batches to test safety and increase "speeding up evaluations."
Wegovy is a drug from Nova Nordisk and was recently touted by Elon Musk on twitter for weight loss but this endorsement was not without controversy.
A company developing a COVID-19 vaccine in Taiwan called Medigen may have worked with a firm in China, which has caused controversy over the data collected on Taiwanese people during the Phase 2 Clinical Trial.
An executive at Pfizer and DWA Healthcare Communications Group offers a multi-part course exploring Data Analysis in Healthcare and more information can be found here.