Registering “Applicable Trial” Data on Managing Disclosure of Negative or Non-significant Results

Held Jan. 24, 2012

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

With reports of industry “cherry picking” on the rise — and new rules currently in development — now’s the time to get expert guidance.

While the Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that sponsors and clinical investigators register all applicable clinical trials and report the results of these trials on the National Institutes of Health’s (NIH) website, many are accused of cherry-picking and only reporting positive trial outcomes.

Yet, is it cherry picking or confusion on what constitutes an applicable clinical trial?

Regardless of your answer, the NIH, FDA and OIG are ramping up enforcement of the requirements and are increasing pressure on firms to report all applicable clinical trials. In 2010, three firms were mandated to comply with registration and reporting requirements through OIG corporate integrity agreements.

It’s a looming crisis for the clinical trials community. Fortunately, help is at hand.

In this audio CD/transcript Scott Cunningham focuses on the new essentials of reporting. In 90 fast-paced minutes, you’ll discover:

  • What the FDAAA says, and how its provisions impact your clinical trials;
  • Current status of the proposed FDAAA 801 rulemaking;
  • Best practices to manage disclosure of negative or non-significant results;
  • Avoiding mistakes when applying the regulatory exemptions;
  • Strategies to assure compliance with the potentially conflicting requirements of, state and international agencies;
  • Untangling FDAAA clinical trials disclosure requirements;
  • How to avoid overstepping the 12-month deadline for applicable clinical trials;
  • Reassessing audit and monitoring processes for results posting;
  • 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

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

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. Mr. Cunningham graduated cum laude from the University of Pennsylvania Law School.

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