The recently enacted U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007), Title VIII- Section 801 now has mandates that effect the NIH-maintained data bank of all clinical trials which qualify for registration at ClinicalTrials.gov. Previously, the data bank only required registration of trials of drugs for serious or life-threatening diseases, and those which were to be considered for publication by the International Committee of Medical Journal Editors (ICMJE).
Steps for registering your clinical trial through UTHSC-Houston:
Browse the Main Menu page. Follow the instructions for changing the temporary password. Refer to the “User’s Guide” for additional information.
Go to Main Menu> Protocol Records> Create, then follow the prompts for creating your registration. As the PI or designee, you are responsible for entering your trial information, ensuring that it is correct, and updating the registry in a timely manner and as required by this law.
Submit the completed registration. The registration will be reviewed and approved by the PRS administrator, then released to the ClinicalTrials.gov databank. Records are made available to the public through the ClinicalTrials.gov web site within 2 to 5 days of release, following system validation and quality assurance review. New records may take up to 30 days to appear in the databank.
Who is responsible for registering trials on ClinicalTrials.gov?
The entity responsible for registering is the “responsible party.” The statute defines the responsible party as:
(1) the sponsor of the clinical trial (as defined in 21 C.F.R. 50.3)
-or-
(2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator 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 under this subsection for the submission of clinical trial information.” See PL 110-85, Section 801(a), (adding new 42 U.S.C. 282(j)(1)(A)(ix)).
Since responsibility for registering trials lies with the lead sponsor of the clinical study, most “industry sponsored” trials will be registered by the sponsor, which can be a pharmaceutical company or CRO. Local sponsor-investigator studies (also known as “investigator initiated studies”), or those who hold an IND or IDE that meet the eligibility criteria, will all need to be registered by the investigator prior to study enrollment, where applicable. If the sponsor of a clinical trial is someone other than the PI, investigators should personally check the registry to ensure that all of the required registration elements are included.
NOTE: Per the Act, sponsors must now also include study results in the registry. The results submissions should include lay language summaries of subject demographics and characteristics, primary and secondary outcomes, and disclosures of any privacy agreements. Timelines for this information are set forth (see related links below).
Which clinical investigations or trials must be registered?
Trials that must be registered under the Act are called “applicable clinical trials.” Under the statute, these trials generally include:
Trials of Drugs and Biologics: Controlled, *clinical investigations, other than Phase 1 investigations, of a product subject to FDA regulation; and
Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.
*The FDA defines a clinical investigation as any experiment in which a drug is administered or dispensed to, or used, involving one or more human subjects. An experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. Purely observational studies are exempt from registration requirements.
ICMJE guidelines define a clinical trial as, “Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome.”
An intervention is any action or ministration that produces an effect or that is intended to alter the course of a pathologic condition or disease process.
How will an investigator know if their trial should be registered?
Investigators should review the statutory definition of applicable clinical trial to identify if any of their trials must be registered to comply with the law. NIH encourages registration of ALL trials whether required under the law or not, and ICMJE advises that those who are uncertain whether their trial meets the ICMJE definition of eligible trials should err on the side of registering if they wish to seek publication in an ICMJE journal.
What if my trial started 4 years ago and I only have one subject left to see?
Trials initiated after 9/27/2007 or trials that are ongoing as of 12/26/2007 must be registered in full by the later of 12/26/2007 or 21 days after the first patient is enrolled.
Trials that were “ongoing” as of as of 9/27/2007 and do not involve a “serious or life threatening disease or condition,” must be registered by 9/27/2008.
Trials that were “ongoing” as of 9/27/2007, and do involve a “serious or life threatening disease or condition,” and are completed (meaning, not “ongoing”) by 12/26/2007 are not subject to these requirements, though they may be subject to pre-existing registering requirements.
How else does the FDA Amendments Act of 2007 affect UTHSC-H Investigators?
The FDA has the authority to enforce compliance to these clinical trial registry requirements put forth by the Act. If a sponsor fails to register any trial which meets the eligibility criteria, fails to submit trial results, or submits false data or information, the NIH will post a notice describing the infractions on the registry data bank. The FDA is also authorized to impose monetary penalties for failure to comply with the requirements of the Act. Any person who violates the provisions of the Act will be subject to penalties up to $10,000. After 30 days of notification, uncorrected violations could incur additional $10,000 daily penalties until the violation is corrected.
