Preparing for Expanded Clinical Trial Data Transparency

Preparing for Expanded Clinical Trial Data Transparency - Webinar CD/Transcript

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Preparing for Expanded Clinical Trial Data Transparency: US and EU Initiatives on the Horizon

In just the last three months, a slew of different initiatives for expanded clinical trial data disclosure and transparency has been introduced in the US and EU. Big changes are on the horizon that could significantly disrupt sponsors’ disclosure policies and operational procedures.

In the US:

  • The Trial and Experimental Studies Act is aimed to close disclosure loopholes and make sure end results are posted.
  • The Clinical Trial Cancer Mission 2020 Act wants companies to disclose results, good and bad.
  • Under FDASIA Section 1124, the FDA is proposing to make available de-identified and masked data from medical product applications. Industry claims this is illegal.

In Europe, the EU’s parliament announced in June it intends to release clinical trial data on all newly-approved drugs to promote faster innovation and establish “trust and confidence in the system.”

Your clinical trial data could be a much more open book.  Are you prepared?

Full disclosure of clinical trial results is one of this year’s hot issues for pharmaceutical and medical device companies and U.S. and EU regulatory bodies are clear that changes are coming.

If you aren’t keeping tabs on all of what is on the horizon, you might be blindsided about what information you have to hand over.

FDAnews, along with one of the leading experts in clinical trial disclosure, Scott Cunningham, provide a roadmap detailing how the latest initiatives could radically impact your company’s trial design, data collection and reporting strategies.

  • Medical Affairs Officers
  • Director of Clinical Operations
  • Regulatory Affairs Professionals
  • Director of Publications
  • Director of Clinical Trial Regulatory Management
  • Clinical Trial Information Disclosure Directors
  • Global Clinical Safety and Pharmacovigilance Officers

Scott Cunningham, Esq is a partner at Covington & Burling LLP, where he is a member of the FDA practice group and both a frequent speaker and writer. Mr. Cunningham has significant experience in areas including new product development and clinical trials; IRBs; new product approvals; Hatch-Waxman exclusivities and product life-cycle management; advertising and promotion; False Claims Act and Anti-Kickback compliance issues and pharmaceutical investigations; Orphan Drug; pediatric exclusivity; manufacturing and cGMPs; import/export; controlled substances; SEC disclosure; and other aspects of federal and state regulation of pharmaceuticals, biologics, and medical devices.