The Food and Drug Administration just issued new guidance for industry sponsors, investigators, and Institutional Review Boards/Independent Ethics Committees to address modifications of drug, biological, and medical device clinical trials that may be required to ensure human subject safety during the COVID-19 pandemic. The European Medicines Agency and the national Heads of Medicines Agencies also issued guidance specific to drug and biological clinical trials. Notably, none of the regulators announced that they are suspending or exercising enforcement discretion regarding legal obligations for clinical trial conduct. They do, however, anticipate that critical decisions and actions may be required.
In a separate matter important to clinical trial sponsors, the U.S. District Court for the Southern District of New York recently decided in Seife v. HHS that the Department of Health and Human Services has been erroneously limiting the disclosure requirements for the ClinicalTrials.gov data bank. If sustained on appeal, the court’s decision could require companies to publicly disclose the basic results – as well as adverse events – for a decade’s worth of clinical trials, going back to September 27, 2007, when Section 801 of the FDA Amendments Act of 2007 took effect.
In this webinar, panelists from King & Spalding’s FDA & Life Science and Appellate teams will discuss the most important issues and far-reaching implications of the new guidance regarding the conduct of ongoing clinical trials, as well as the court’s decision regarding public disclosure of clinical trial results. See the King & Spalding Life Sciences team’s alert about the FDA and EU Guidance here and an alert about the SDNY Decision here. Topics to be addressed include:
- Whether participant safety in a sponsor’s clinical trials is best served by halting or continuing recruitment, test product administration, or the trial itself;
- What to consider regarding challenges in monitoring and test product accountability;
- How to address protocol deviations and changes, including those to minimize immediate hazards from participant or investigational staff exposure to COVID-19;
- How the new European and FDA guidances differ;
- Key issues for companies to understand about the basis of the court’s decision about “pre-rule, pre-approval” applicable clinical trials in Seife v. HHS;
- Act now or wait? – implications for companies considering retroactive submission of basic results to ClinicalTrials.gov.
Friday, April 3
1:00 P.M. – 2:30 P.M. ET
King & Spalding is an accredited provider of CLE credit in California, Georgia, Illinois, New York and Texas. We can issue reciprocal credit for attorneys licensed in Connecticut, Florida, and New Jersey. We will apply for credit in Colorado, North Carolina, Tennessee and Virginia (subject to MCLE Board approval). For jurisdictions not listed, attendees are provided with a Universal Certificate of Attendance. New York licensed attorneys: Transitional/Appropriate for newly-admitted and experienced attorneys. The live, interactive webinar is approved for both Experienced and Newly Admitted attorneys. Financial aid is available for qualifying lawyers. For CLE-related questions, please contact Gisel Arias, email@example.com. King & Spalding, 1180 Peachtree Street NE, Atlanta, GA 30309. CA Provider #10947.
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