Feb 8 -- The National Institutes of Health (NIH) invites public comments to OMB by March 10, 2023 regarding the Information Program on Clinical Trials: Maintaining a Registry and Results Databank (National Library of Medicine).
The National Institutes of Health operates ClinicalTrials.gov, which was established as a clinical trial registry under section 113 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) and was expanded to include a results data bank by title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and by the Clinical Trials Registration and Results Information Submission regulations at 42 CFR part 11.
ClinicalTrials.gov collects registration and results information for clinical trials and other types of clinical studies (e.g., observational studies and patient registries) with the objectives of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical studies to the benefit of public health. It is widely used by patients, physicians, and medical researchers; in particular those involved in clinical research. While many clinical studies are registered and results information submitted voluntarily, 42 CFR part 11 requires the registration and submission of results information for certain applicable clinical trials of drug, biological, and device products whether or not they are approved, licensed, or cleared by the Food and Drug Administration.
ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH). Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted to the Web site (that is, registered) when they begin, and the information on the site is updated throughout the study. In some cases, results of the study are submitted after the study ends. This Web site and database of clinical studies is commonly referred to as a "registry and results database."
ClinicalTrials.gov contains information about medical studies in human volunteers. Most of the records on ClinicalTrials.gov describe clinical trials (also called interventional studies). A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes. ClinicalTrials.gov also contains records describing observational studies and programs providing access to investigational drugs outside of clinical trials (expanded access). Studies listed in the database are conducted in all 50 States and in 221 countries.
This information collection addresses an important public health need by providing patients, family members, clinicians, and researchers with timely access to up-to-date information about clinical trials as well as other types of clinical studies, and their results. The registration information enables patients and their family members to learn about relevant studies and facilitate possible enrollment. Alone or when combined with collected results information, it can also contribute to better-informed decisions about medical treatments. In addition, clinical trial information can reduce inadvertent and unnecessary duplication of clinical research studies, help reviewers detect incomplete reporting of the results of specific trials, allow comprehensive analysis and reporting of the results of many trials of specific therapies, and therefore provide regulators, scientists, health professionals, and the public a more accurate picture of the benefits and potential harms of specific therapies or products and a more solid foundation for decision-making. The NIH and the FDA have encouraged the registration of clinical trials in publicly accessible databanks; as such, information is not otherwise easily accessible to the general public.
ClinicalTrials.gov is a unique information resource, containing registration information on over 429,000 clinical studies in more than 200 countries as of September 30, 2022. No comparable public listing of clinical trials exists in the world. While some companies make some clinical trial information available through commercial databases, these efforts are not as comprehensive as ClinicalTrials.gov and contain limited information on only a select subset of trials. Similarly, the results information collected by ClinicalTrials.gov is unique. While a small number of pharmaceutical companies have created public websites containing results of their clinical studies, they are limited to the company’s trials and results are not structured to allow easy comparison among trials in different databases. The industry association PhRMA established a publicly accessible results database for member companies, but submission of information was voluntary and therefore limited. PhRMA decommissioned and removed this results database in 2012.
ClinicalTrials.gov:
https://clinicaltrials.gov/
Beta site:
https://beta.clinicaltrials.gov/
NIH submission to OMB:
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202302-0925-001 Click IC List for information collection instrument, View Supporting Statement for technical documentation. Submit comments through this webpage.
FRN:
https://www.federalregister.gov/d/2023-02381
For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at
https://www.aeaweb.org/content/file?id=5806