Three little words, “applicable clinical trial.” How have they become so difficult to understand when it comes to registering trials on ClinicalTrials.gov?
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) ClinicalTrials.gov 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:
Spread the word throughout your organization. Make particularly sure to notify the following key staff:
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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