Life Science Compliance Update

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September 19, 2016

New Rule and Guidance Issued on Clinical Trials

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Clinical trials are one of the most visible components of the biomedical research field, in part due to the way they directly engage human participants. Clinical trials have done a lot of good, providing advances in diagnosis, treatment, and prevention, but there are still large challenges. As such, changes are always needed to reflect science and society’s movement to increase efficiency, accountability, and transparency in clinical research.

Health and Human Services Final Rule

In an effort to make information about clinical trials more widely available to the public, the United States Department of Health and Human Services (HHS) issued a final rule that specifies requirements for registering certain clinical trials and submitting results information to ClinicalTrials.gov. The final rule expands the legal requirements for submitting registration and results information for clinical trials that involve drug, biological, and device products regulated by the Food and Drug Administration (FDA).

The requirements found within the rule generally apply to the “responsible party,” typically the sponsor of the clinical trial or designated principal investigator. The rule lays out a process for determining who the rule applies to, and which studies are considered “applicable clinical trials.”

Requirements under the final rule apply to most interventional studies of drug, biological and device products that are regulated by the FDA. The requirements do not apply to phase 1 trials of drug and biological products, or small feasibility studies of device products. The final rule also specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov. It does not, however, dictate how clinical trials should be designed or conducted, or what data must be collected.

Responsible parties must register their trial within twenty-one days of enrolling the first participant. The rule includes specific data elements that are to be submitted upon registration. Additionally, if the product studied is available via expanded access (when a product is used outside of a clinical trial, before it is FDA approved), the responsible party shall submit information about how patients can get access to that product.

Results information from applicable clinical trials shall generally be submitted within one year after the trial’s primary completion date. Submission of results information may be delayed, in certain circumstances, for up to two additional years for trials of products regulated by the FDA that are unapproved, unlicensed, or uncleared.

The type of information submitted will consist of “tables of information summarizing: 1) participant flow information, 2) demographics and baseline characteristics of the enrolled participants, 3) primary and secondary outcomes, including results of any scientifically appropriate statistical tests, and 4) adverse events.” As part of adverse events information there will be a table for all-cause mortality. The information will be submitted in aggregate, with no personally identifiable information. The rule requires responsible parties to update the information annually.

The final rule will be effective January 18, 2017. As of that date, ClinicalTrials.gov will allow responsible parties to comply with the rule; there is a ninety-day grace period for responsible parties to come into compliance with the requirements of the rule.

National Institutes of Health Policy Guidance

The National Institutes of Health (NIH) is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is the largest public funder of clinical trials in the United States. With such investment comes great responsibility. As such, NIH must work to ensure supported trials: investigate a mission-relevant question of high priority, do not duplicate previously conducted trials that do not need replication, and have the highest likelihood to advance knowledge and improve health.

NIH has launched a new effort to improve the quality and efficiency of clinical trials. These initiatives will reengineer the process by which clinical investigators develop ideas for new trials, how NIH reviews and selects clinical trials for support and oversees the progress of the research, and how results and aggregate data are shared broadly and rapidly.  

As part of the aforementioned initiatives, NIH issued a policy on the same day as the HHS final rule, in an attempt to promote broad and responsible dissemination of information from NIH-funded clinical trials through ClinicalTrials.gov. The policy establishes the expectation that investigators that conduct clinical trials funded at all by NIH will ensure that the trials are properly registered and that results information of the trials are submitted to ClinicalTrials.gov.

The policy, similar to the rule, requires applicable clinical trials to be registered in ClinicalTrials.gov no later than twenty-one calendar days after the enrollment of the first participant.

Applicants and offerors seeking NIH funding will be required to submit a plan for the dissemination of NIH-funded clinical trial information that will address how expectations contained within the policy will be met.

The new NIH policy applies to all NIH-funded trials, including phase 1 clinical trials of FDA-regulated products and small feasibility device trials, as well as products that are not regulated by the FDA, such as behavioral interventions.

The policy will take effect January 18, 2017. Failure to comply with the terms and conditions of the policy may result in enforcement actions, including termination.

FDA and NIH Comments

“When people participate in clinical trials, they are volunteering to create generalizable knowledge to help others in the future and we want their participation honored by ensuring that the existence of trials and their results are available to all patients and their healthcare providers, as well as researchers,” said FDA Commissioner Robert M. Califf, M.D. “The FDA will help ensure compliance with these new requirements so that patients and providers can have confidence in and access to significantly more clinical trial information, and researchers can improve clinical trial focus and design.”

“Access to more information about clinical trials is good for patients, the public and science,” said NIH Director Francis S. Collins, M.D., Ph.D. “The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health.”

A summary table of both the final rule and new guidelines can be found here.

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