Subject: Clinical Trials Registration New Federal Requirements - Important Message from Gordon R. Bernard, Assistant Vice Chancellor for Research
Dear Fellow Investigators:
This e-mail is to inform you of the newly enacted law promulgated by Congress regarding the registration of clinical trials at the ClinicalTrials.gov. The law expands the scope of the clinical trials that must be registered, number of specified data elements required (several data elements that were previously optional will become required), imposes deadlines and penalties for failure to comply. I ask that you evaluate your clinical trials to determine whether registration is now required and if so, ensure they are registered by the deadlines specified below. Those who already have ClinicalTrials.gov accounts should log into the Protocol Registration System (PRS) for the latest information on the changes currently in progress. If it is the responsibility of an industry sponsor to register the trial, you should still ensure it has been properly registered prior to enrolling participants.
What are the “applicable clinical trials” that must be registered?
1. Trials of Drugs and Biologics: clinical investigations, other than a phase I investigations, of a product subject to FDA regulation
2. Trials of Devices:
a. a prospective clinical study of health outcomes of devices subject to FDA, other than small feasibility studies
b. a pediatric postmarket surveillance
Reminder: The members of the International Committee of Medical Journal Editors (ICMJE) will consider a trial for publication only if it has been registered publicly before enrollment of the first patient. http://www.icmje.org/clin_trialup.htm
Who is responsible for Registration?
The “Responsible Party” is defined as:
1. Commercial Sponsor of the clinical trial
2. Principal investigator
a. If so designated by a sponsor, grantee, contractor, or awardee so long as the PI is responsible for conducting the trial and has sufficient data rights (access to and control over the data from the clinical trial, the right to publish the results of the trial, and the ability to meet all of the requirements for submitting information under the law).
b. If you are the Investigational New Drug Application (IND) or Investigational Device Exemption (IDE) holder, you may be the “sponsor” as that term is defined in the FDA regulations (21 CFR 50.3).
c. If you are a Principal Investigator who has been delegated registration duties by the sponsor.
d. If you are the funding recipient you may be considered the “responsible party” as defined in the Act. For extramural trials, NIH is not the responsible party.
What are the deadlines for registration of clinical trials under the enacted law?
1. Trials that involve a “serious or life threatening disease or condition” ongoing or initiated after 12/26/07 must be registered in full by the later of 12/26/2007 or 21 days after the first patient is enrolled.
2. Trials that do not involve a “serious or life threatening disease or condition” that were ongoing on 9/27/2007, must be registered within 1 year after enactment (9/27/2008).
“Ongoing” is defined as a trial that had one or more patients enrolled, but had not examined the final subject or provided the final subject an intervention for the purposes of final collection of data for the primary outcome as of 9/27/2007.
3. Important Note: Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Pub. L. 110-85) mandates the establishment of a clinical trial results database. The inclusion of "basic results" information in the database is required by 9/27/2008.
‘‘(i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS OF PATIENT SAMPLE.—A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any.”
‘‘(ii) PRIMARY AND SECONDARY OUTCOMES.—The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures.”
‘‘(iii) POINT OF CONTACT.—A point of contact for scientific information about the clinical trial results.”
‘‘(iv) CERTAIN AGREEMENTS.—Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator)
that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial.”
Penalties for failing to register an “applicable clinical trial”:
Penalties for responsible parties who fail to register, or provide false or misleading information in connection with, applicable clinical trials are significantand may include civil monetary penalties and, for federally-funded trials, the withholding or recovery of grant funds. See PL 110-85, Sections 801(a), (b), (adding new 42 U.S.C. 282(j), and new 21 U.S.C. 331(jj)). http://prsinfo.clinicaltrials.gov/s801-fact-sheet.pdf
CAUTION: It is your responsibility to ensure that your registration meets the requirements of applicable laws and regulations. Acceptance by ClinicalTrials.gov in the Protocol Registration System (PRS) and assignment of a National Clinical Trial (NCT) number to a registration record does not ensure compliance with applicable laws.
Contact Research Support Services if you have questions regarding the law or need assistance registering a trial at (615) 322-7344 or . Additional information on the new registration requirements is available on the PRS Web site http://prsinfo.clinicaltrials.gov/.