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Clinical trials are prospective biomedical or behavioral studies on human participants designed to answer specific questions about new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that further confirm the biomedical or behavioral intervention. Study. Studies and comparisons. Clinical trials generate data about dosage, safety, and efficacy. They are administered only after obtaining approval from the health authority/ethics committee in the country where approval of the therapy is sought. These authorities are responsible for verifying the risk/benefit ratio of the trial—their approval does not mean that the therapy is ‘safe’ or effective, only that the trial can be conducted.
Depending on the product type and stage of development, investigators initially enroll volunteers or patients in small pilot studies and then gradually conduct large-scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or multiple countries. Clinical study design aims to ensure scientific validity and reproducibility of results.
Clinical trial costs can be in the billions of dollars per drug approved. The sponsor can be a government agency or a pharmaceutical, biotechnology or medical device company. Some functions required for the trial, such as monitoring and lab work, may be performed by an outsourced partner, such as a contract research firm or a central laboratory. Only 10 percent of all drugs that start in human clinical trials become approved drugs.
