Registering Clinical Trials
New clinical trial registration requirements may apply to you
The FDA Amendments Act of 2007 contains new trial registration requirements at ClinicalTrials.gov (including an expanded scope of trials that must be registered, more data elements, rules regarding when it is the PI’s responsibility to register a trial) which in some cases apply to already ongoing and registered trials. The earliest of several deadlines you may need to meet is December 26, 2007. Consequences of not registering include monetary and civil penalties. Some highlights and guidance regarding the law (and particularly about when it is the PI’s responsibility) appear below. PIs are responsible for determining whether or not they are obligated to register in accordance with the law.
Even if you and/or your trial are not covered by this law, it makes sense to register your trial for a variety of other reasons, the most important of which may be to allow its publication in the peer-reviewed medical literature. The ICMJE (International Committee of Medical Journal Editors, including JAMA, NEJM, Annals of Internal Medicine, Lancet, etc) continues to require, as a condition of publication, registration in a public trials registry.
Note that even though it is often the PI’s responsibility to make sure the trial is registered, PIs who work at an institution or lead an NIH grant generally register the trial via the NIH (e.g. the awarding institute or center) or the grantee institution (with access granted through the grantee organization (e.g. BU, BMC)) ClinicalTrials.gov. Less commonly, the PI establishes an individual account and does the registration themselves (e.g. a PI leading a trial through their own separate private company). If you require access to register a trial, contact grants administration (ellen.jamieson@bmc.org ) for BMC studies or the Office of Clinical Research (kkhattar@bu.edu ) for BU studies for a username and password.
The following links provide detail:
The new law:
[http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf]
NIH Guidance:
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-014.html
ClinicalTrials.gov info and FDA law fact sheet :
http://prsinfo.clinicaltrials.gov
http://prsinfo.clinicaltrials.gov/fdaaa.html
ICMJE statements:
http://www.icmje.org/clin_trialup.htm
http://www.icmje.org/#clin_trials
Further detail regarding the new law:
What does the new law mean: Trials that must be registered generally include Phase 2-4 trials of drugs and biologics as well as devices. NIH, which manages ClinicalTrials.gov, encourages the registration of all clinical trials.
Who is responsible: The registration responsibilities fall on the sponsors and PIs of the clinical trials.
- The individual/entity defined by the FDA as the “sponsor” (e.g., the IND/IDE holder) is responsible to register “applicable clinical trials.”
- A PI is responsible for registering clinical trial information “when the PI is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements for submitting information under the law.” [http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=110_cong_public_laws&docid=f:publ085.110.pdf]
The guidance provides three categories under which the PI is or may be required to register a clinical trial with clinicaltrials.gov:
- For investigator- initiated trials, where the PI is the sponsor (PI holds the IND/IDE): PI is responsible
- When the PI is not the sponsor (does not hold the IND/IDE), but is delegated registration duties by the sponsor: PI is responsible
- For extramural clinical trials funded by NIH where there is no IND/IDE holder: PI may be responsible depending on the circumstances of the trial (consult with NIH)
When must a trial be registered: Key deadlines are December 26, 2007 and September 27, 2008.
- Trials initiated after 9/27/07 or ongoing as of 12/26/07 must be registered in full by the later of 12/26/07 or 21 days after the first patient is enrolled.
- Trials that were ongoing as of 9/27/07 and do not involve serious or life threatening diseases or conditions must be registered by 9/27/08.
- Trials that were “ongoing” as of as of 9/27/2007, do involve a serious or life threatening disease or condition, and are completed by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registering requirements.
Penalties for failing to register applicable trials are serious, and include civil monetary penalties and, for federally-funded trials, the withholding or recovery of grant funds.
