The U.S. Department of Health and Human Services (HHS) recently announced policy changes designed to make information about clinical trials of investigational drugs, biologics and products more widely available to the public, issuing amended rules that specify the requirements for registering clinical trials and for submitting summary results to its ClinicalTrials.gov website.
The new rules expand the legal requirements for registering trials and reporting results for trials into medications or products requiring U.S. Food and Drug Administration (FDA) approval, and which the agency regulates.
Clinical trials are an essential step in treatment discovery and in the evaluation of a potential therapy’s safety and efficacy, and in the understanding of disease causes and likely progression. They are particularly important in treating such chronic diseases as multiple sclerosis.
Taking effect on Jan. 18, 2017, the changes provide for the expansion of the clinical trial registry and of a results databank, in order to:
- help individuals find clinical trials for which they might be eligible
- enhance the design of clinical trials to prevent the duplication of unsuccessful or unsafe trials
- improve the evidence base that informs clinical care
- increase the efficiency of drug and device development processes
- improve clinical research practice
- enhance public trust in clinical research
Concurrently, The National Institutes of Health (NIH) has issued complementary policy amendments that clarify and expand the requirements for submission of clinical trial registration and results information to the ClinicalTrials.gov database. That database currently lists 225,647 studies being conducted at locations in all 50 states and in 192 countries.
The purpose of these NIH changes is to promote broad and responsible dissemination of information from all NIH-funded clinical trials through ClinicalTrials.gov. The amended policy establishes the expectation that trial investigators funded in whole or in part by the NIH will ensure that these trials are registered at ClinicalTrials.gov, and that results from these trials are made available.
“Access to more information about clinical trials is good for patients, the public and science,” said the NIH director, Francis S. Collins, MD, PhD, in a press release. “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.”
The new rule does not apply to Phase 1 trials of drug and biological products (often involving healthy participants), or to small feasibility studies of device products or therapies not regulated by the FDA, such as behavioral interventions. The rule specifies how and when information collected in a clinical trial must be submitted to ClinicalTrials.gov, but does not dictate how clinical trials should be designed or conducted, or which data must be collected.
Clinical trials are vital to medical advances, rigorously testing new and existing health-related interventions. Data derived help regulators and healthcare providers determine whether new discoveries and innovations are safe and therapeutically effective in humans when used as intended, as well as providing information about which medical treatments work best for certain illnesses or in certain groups of people.
Improving the registration information available on ClinicalTrials.gov is meant to make it easier for people to find clinical trials they may be able to participate in, gaining access to investigational therapies. More information about scientific findings, whether positive or negative, also helps inform healthcare providers and patients when making decisions, and sharpens researchers’ focus on areas where study designs can be improved, the NIH said.
ClinicalTrials.gov is a web-based resource created under the Food and Drug Administration Modernization Act of 1997. It requires HHS, through the NIH, to establish a registry of clinical trial information for both federally and privately funded trials, conducted under investigational new drug applications, to test the effectiveness of treatments for serious or life-threatening diseases or conditions. The web resource provides patients, healthcare professionals, researchers, and the public with easily accessible information on publicly and privately supported clinical studies pertaining to a wide range of diseases and conditions.
The ClinicalTrials.gov website is maintained by the National Library of Medicine (NLM) at the NIH, with information provided and updated throughout the study by the sponsor or trial principal investigator.
Its database also contains records describing observational studies and programs providing access to investigational drugs outside of clinical trials. Searching ClinicalTrials.gov does not require registration or personal identification, and because it is a government website, it does not display commercial content.
“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 Robert M. Califf, MD, FDA commissioner . “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.”
The National Institutes of Health (NIH)
The U.S. Department of Health and Human Services (HHS)