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Just when you thought the list of COVID-19 symptoms couldn't get any longer, studies show hair loss and thinning hair should be added to the ever-growing list. One study followed 806 participants ...
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In medicine, a clinical study report (CSR) on a clinical trial is a document, typically very long, providing much detail about the methods and results of a trial. A CSR is a scientific document addressing efficacy and safety, not a sales or marketing tool; its content is similar to that of a peer-reviewed academic paper. [ 1 ]
PRP is derived from the patient's own blood and may contain growth factors that increase collagen production. [3] It can be applied topically to the entire treatment area during and after collagen induction therapy treatments or injected intradermally to scars. Efficacy of the combined treatments remains in question pending scientific studies ...
Case report forms contain data obtained during the patient's participation in the clinical trial. Before being sent to the sponsor, this data is usually de-identified (not traceable to the patient) by removing the patient's name, medical record number, etc., and giving the patient a unique study number.
Clinical trial registration is the practice of documenting clinical trials before they are performed in a clinical trials registry so as to combat publication bias and selective reporting. [25] Registration of clinical trials is required in some countries and is increasingly being standardized. [ 26 ]
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]
In Canada, a Clinical Trial Application (CTA) must be filed with the Health Products and Food Branch (HPFB) of Health Canada before starting a clinical trial. If the clinical trial results show that therapeutic effect of the drug outweighs negative side effects then the sponsor can then to file a New Drug Submission. [4]