April 10, 2020

Webinar Recording: Modifying Clinical Trials: Regulatory, Liability & Insurance Considerations

As the second in a series of PropSci Virtual Meetings, Goodwin’s Life Sciences FDA, Healthcare, Products Litigation & Counseling, and Risk Management & Insurance and Healthcare Regulatory practice groups hosted a multidisciplinary webinar discussion on Tuesday, March 31, 2020 entitled “Modifying Clinical Trials: Regulatory, Liability & Insurance Considerations.” The webinar addressed regulatory, liability and insurance considerations regarding clinical trial modifications in light of the COVID-19 pandemic.

PropSci Co-Chair Andy Sucoff moderated a conversation with Julie Tibbets, Roger Cohen, Carl Metzger and Sarah Frederick focused on regulatory and legal issues that clinical trial sponsors must navigate in implementing modifications to ongoing or planned clinical trials due to COVID-19.

Topics included:

  • Clinical Trials Modifications, Delays, and Terminations: Deciding whether and how current trials can continue and whether planned studies should be redesigned
  • Informed Consent/Reconsent Impacts: Amending existing informed consents and factoring COVID-19 into future consents
  • Liability Implications: Reviewing informed consent clauses
  • What This Means for Insurance: Proceeding with studies and patient visits in current study environments and commencing/planning new studies

View the webinar recording below and please click here to view the slide presentation.