Pilot experiments are conducted to gain insights for design of the clinical trial to follow.
Other clinical trials pertain to people with specific health conditions who are willing to try an experimental treatment. Some clinical trials involve healthy subjects with no pre-existing medical conditions.
Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Clinical study design aims to ensure the scientific validity and reproducibility of the results.Ĭosts for clinical trials can range into the billions of dollars per approved drug. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. These authorities are responsible for vetting the risk/benefit ratio of the trial-their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.ĭepending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. Clinical trials generate data on dosage, safety and efficacy. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. A clinical trial participant receives an injectionĬlinical trials are experiments or observations done in clinical research.
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