Nov 15 -- The National Library of Medicine (NLM), National Institutes of Health (NIH), HHS invites comments by January 17, 2023 regarding the Information Program on Clinical Trials: Maintaining a Registry and Results Databank.
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 submit results information voluntarily, 42 CFR part 11 requires the registration of certain applicable clinical trials of drug, biological, and device products and the submission of results information for completed 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.
ClinicalTrials.gov does not contain information about all the clinical studies conducted in the United States because not all studies are required by law to be registered (for example, observational studies and trials that do not study a drug, biologic, or device). See FDAAA 801 and the Final Rule for more information. However, the rate of study registration has increased over time as more policies and laws requiring registration have been enacted and as more sponsors and investigators have voluntarily registered their studies.
Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following:
Disease or condition
Intervention (for example, the medical product, behavior, or procedure being studied)
Title, description, and design of the study
Requirements for participation (eligibility criteria)
Locations where the study is being conducted
Contact information for the study locations
Links to relevant information on other health Web sites, such as NLM's MedlinePlus® for patient health information and PubMed® for citations and abstracts of scholarly articles in the field of medicine
Some records also include information on the results of the study, such as:
Description of study participants (the number of participants starting and completing the study and their demographic data)
Outcomes of the study
Summary of adverse events experienced by study participants
ClinicalTrials.gov was made available to the public on February 29, 2000, and the results database was released in September 2008. Once a study is registered on the site, it is not removed. The full history of the changes made to a record can be accessed by clicking on the History of Changes link near the bottom of the full text view of each record.
ClinicalTrials.gov:
https://clinicaltrials.gov/
Draft data collection instruments and technical documentation:
https://www.dropbox.com/scl/fo/75dctpe4pssaw9mcwg8o3/h?dl=0&rlkey=mo635bao065ptiq6m0s0drl5r
FRN:
https://www.federalregister.gov/d/2022-24859