Falsified Data in Clinical Trials How to Determine What to Report to the FDA

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Is the FDA about to name you their fraud police? A proposed new rule will require sponsors to report data falsifications … without any proof … without a possible motive … and even if there’s only a suspicion of fraud.

The FDA sent shockwaves through the industry on Feb. 19 when it announced a proposed rule called “Reporting Information Regarding Falsification of Data.”

The rule will require sponsors to report any information that indicates that a person has, or may have, engaged in the falsification of data involving clinical investigations, nonclinical laboratory studies and clinical studies in animals. Specifically, it says:

  • You must report a data falsification within 45 calendar days from the time you become aware of it
  • Mere “suspicion” of non-compliance will be enough ammunition for a sponsor to pull the trigger
  • You won’t be required to provide any proof of falsification, or even a possible motive
  • The FDA can decide at any time if the provided information warrants further investigation
  • Any information you provide to the FDA can become the foundation for excluding clinical trials from consideration, placing a clinical trial on hold, initiating disqualification of investigators or conducting criminal proceedings

What exactly is going on here? Is the FDA trying to turn sponsors into detective, judge and jury?

To learn more about this controversial proposal, sign up today for the FDAnews Encore presentation, Falsified Data in Clinical Trials: How to Determine What to Report to the FDA.

We’ve engaged two top experts with who have the unique backgrounds needed to thoroughly discuss the proposal. David Clissold has conducted clinical and pre-clinical research at Nova Pharmaceuticals and Johns Hopkins School of Medicine; Nisha Shah is an analyst who has developed economic models of cost-effectiveness and cost benefits of pharma products. Both Clissold and Shah are attorneys, currently practicing at the law firm of Hyman, Phelps & McNamara. Their combined experience provides them with a unique perspective — one that’s sure to be invaluable to attendees of this session. (See their complete bios below.)

Their information-packed 90-minute session will help you make sense of the dramatic changes that will be set in motion when this proposed rule is added to 10 different regulations within 21 CFR. You’ll also get answers to your toughest questions, including:

  • Key definitions — how will the rule define terms like sponsor, and falsification of data?
  • What information must you, as a sponsor, give the FDA when possible falsification is reported?
  • How will the agency know if you’re taking the appropriate steps in reporting the errors? Is this just a good faith-type measure?
  • What is the gray area separating what the FDA calls errors and possible falsification?
  • When would a sponsor be required to report information about the falsification of data?
  • What potential penalties could sponsors incur if they do not report confirmed or possible falsification?
  • What is the FDA’s timeline, to enforce if this proposed rule becomes a final rule?

Plus, if you’re planning to comment by May 20, Clissold and Shah will analyze and discuss current comments in the public docket to help you craft your own comment.

Attending is easy and cost-effective: simply make sure you're in front of a screen at the appointed time, whether in your office or your office-in-home, and get ready to learn. And one low registration fee per facility means you can sign up one — or 100 — of your colleagues, and never pay a penny more.

Be ready with your own questions, too; you can submit them via email for answers by the time the session ends.

Don’t spin your wheels on this difficult proposal. Turn to the experts; register today for Falsified Data in Clinical Trials.

  • Regulatory affairs
  • Clinical quality assurance managers and auditors
  • Clinical research associates
  • Clinical site director

David Clissold is a director at Hyman, Phelps & McNamara. He advises pharmaceutical, biotechnology, medical device and food/dietary supplement industry clients on regulatory and legislative matters. He has also advised health care professionals, major universities and medical schools on regulatory compliance, as well as provided pro bono counsel to state health care agencies and patient groups. Before joining the firm in 1996, Mr. Clissold conducted clinical and preclinical research at Nova Pharmaceutical and the Johns Hopkins University School of Medicine. He has a B.S. in psychobiology from the University of California at Los Angeles and a M.A. in experimental psychology from Indiana University. Mr. Clissold is admitted to practice law in the District of Columbia and Maryland, and is registered to practice before the U.S. Patent and Trademark Office.

Nisha Shah is an associate at Hyman, Phelps & McNamara. She earned a law degree from The George Washington University Law School in 2007, graduated with merit honors from London School of Economics with a master’s of science in international health policy in 2000, and from Cornell University with a B.A. in economics in 1998. Before entering law school, Ms. Shah worked for a contract research organization where she developed health economic models to determine the cost-effectiveness and cost benefits of pharmaceutical products. In this role, she also managed and analyzed patient registries to determine patient-reported outcomes, quality of life, and long-term costs of pharmaceutical products. Prior to that, Ms. Shah worked as an analyst for the European generic pharmaceutical trade association in Brussels. She is admitted to practice in the District of Columbia and Maryland.

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Date: May 25 – June 11, 2010
Location: Your office or conference room (no need to travel!)
Time: Anytime

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