New Requirements for Registration

ClinicalTrials.gov

• Web-based open-access clinical trial database repository containing information about active and closed clinical trials
• NIH managed through the National Laboratory of Medicine
• Federal Modernization Act of 1997, P.L. 105 – 115, (FDAMA) established clinicaltrial.gov (active 2000); reporting of drug trials involving serious and life threatening diseases or conditions, Group C cancers, and expanded use required
• FDA Amendments Act of 2007, P.L. 110-85, (FDAA) established mandatory reporting of applicable clinical trials involving drugs, biologics, and devices plus (in the future) reporting of results  (possibly including serious and frequent adverse events)
  • Register on-going applicable Phase II-IV drugs, biologics, and device trials for all diseases and conditions (by later of 26 Dec 07 or 21 days after first subject is enrolled)
  • Applicable Drug/Biologic Trial: Controlled clinical investigation; Clinical investigation means any experiment in which a drug/biologic is administered or dispensed to, or used, involving one or more human subjects
  • Applicable Device Trial: Prospective clinical study of health outcomes comparing an intervention with a device [including 510(k) (substantially equivalent), 515 (Class III), and 520(m) (humanitarian device exemption)], against a control in human subjects (other than a small clinical trial to determine the feasibility of a device where the primary outcome measure relates to feasibility and not to health); Additionally, post-marketing pediatric device trials.