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The analogy is that the Janus data repository would enable the FDA and the pharmaceutical industry to both look retrospectively into past clinical trials, and also relative to one or more current clinical trials (or even future clinical trials thru better enablement of clinical trial design). The Janus data model is a relational database model ...
As a result of pressure from HIV-infected men in the gay community, [citation needed] who demanded better access to clinical trials, the U.S. Congress passed the Health Omnibus Programs Extension Act of 1988 (Public Law 100-607) [2] which mandated the development of a database of AIDS Clinical Trials Information Services (ACTIS). [3]
FDA: Guidance for Sponsors, Clinical Investigators, and IRBs Data Retention When Subjects Withdraw from FDA Regulated Clinical Trials. This guidance describes the FDA policy that already-accrued data, relating to individuals who cease participating in a study, are to be maintained as part of the study data.
The DRKS is an open access, free of charge online register for clinical trials and is available both in English and German. DRKS is part of the WHO's ICTRP. The DRKS works with two partner registries in Germany, DeReG (German Registry for Somatic Gene-Transfer Trials) and Clinical Trial Registry of the University Medical Center Freiburg. [4]
Aggregating safety data across clinical trials during drug development is important because trials are generally designed to focus on determining how well the drug works. The safety data collected and aggregated across multiple trials as the drug is developed allows the sponsor, investigators and regulatory agencies to monitor the aggregate ...
(Reuters) -The U.S. Food and Drug Administration on Wednesday recommended steps for drugmakers and medical device makers to improve racial, ethnic and other diversity in their clinical trials.
The new drug, amycretin, similar to the company's blockbuster weight-loss and diabetes drugs Wegovy and Ozempic, provided weight loss of up to 22% in early-stage clinical trials.
SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).