Registering Applicable Trial Data on ClinicalTrials.gov

Registering “Applicable Trial” Data on ClinicalTrials.gov - Webinar CD/Transcript

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Registering “Applicable Trial” Data on ClinicalTrials.gov: What Strategic Decisions Do You Need to Consider?

Three little words, “applicable clinical trial.” Why have they become so difficult to understand when it comes to registering trials on ClinicalTrials.gov?

That’s just the tip of the iceberg. The EU has now finalized requirements for submitting trial data into a publically accessible database. Are you confident in your global clinical trial disclosure strategy?

While the FDA requires that sponsors and clinical investigators register all applicable clinical trials and report the results of these trials on the ClinicalTrials.gov website, are you sure you’re submitting everything necessary and complying with the required timelines?

Still not sure about your strategy for submitting trials to ClinicalTrials.gov? Well, you’ll also need to get ready to submit your trials to the EU as well.

After considerable politically wrangling, the EU has finalized the obligation for sponsors to submit a results summary, regardless of the study outcome, to a publicly accessible database within one year of the trial ending, as well as an additional summary understandable to lay people.

Scott Cunningham — a partner at Covington & Burling — focuses on the new reality of US and EU reporting. In the webinar CD and transcript, you’ll discover:

  • Best practices in managing and compiling with clinical trial disclosure requirements in the United States — what success and failures have occurred in the short life of ClinicalTrials.gov submissions
  • The four elements of an “applicable drug clinical trial” and what does the FDA interpret these words to really mean
  • Who must submit clinical trials results to ClinicalTrials.gov and when should trial data be submitted
  • The enforcement landscape for ClinicalTrials.gov — what can the FDA do regarding non-compliance and when could enforcement start
  • How to decipher the ClinicalTrials.gov “voluntary submissions” provisions
  • How patent considerations surrounding the ClinicalTrials.gov database could impact your submission strategies
  • How to navigate the provisions for “delayed submission” of results to ClinicalTrials.gov
  • How to plan controversial “expanded” results reporting requirements
  • The current status of FDA proposals for release of de-identified data
  • And much more…

Why risk fines, penalties or worse, when preparing for these new reporting rules could be so painless? Don’t wait another minute. Order now.

Spread the word throughout your organization. Make particularly sure to notify the following key staff:

  • 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 is a partner within Covington & Burling’s Food and Drug practice group. He represents pharmaceutical, biotechnology, and medical device companies as well as trade associations in matters before the FDA, Congress, state and federal courts, and other regulatory and enforcement agencies. 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. Scott received his B.A. from the University of Pennsylvania and his J.D. cum laude from the University of Pennsylvania Law School.