Medical and scientific research and conducting clinical trials Forms for Pima
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FAQ
A study that tests the safety and how well a new treatment works compared with a standard treatment. For example, phase III clinical trials may compare which group of patients has better survival rates or fewer side effects.
While there are a lot of similarities, the key difference is that medical treatment is intended to benefit and help you while using accepted procedures and products, whereas clinical research is intended to learn about a medication to potentially help patients in the future.
Types of clinical trialsPilot studies and feasibility studies.Prevention trials.Screening trials.Treatment trials.Multi-arm multi-stage (MAMS) trials.Cohort studies.Case control studies.Cross sectional studies.More items...?
Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy's safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
In accordance with the provisions of the 2019-CTRules, the Drugs Controller General of India (DCGI) heads CDSCO, and is responsible for granting permission for clinical trials to be conducted and for regulating the sale and importation of drugs for use in clinical trials.
Each stage of a clinical trial has its own purpose in ensuring that a treatment is safe and effective for use by the public.Phase 1 Clinical Trial.Phase 2 Clinical Trial.Phase 3 Clinical Trial.Monitoring Post-FDA Approval.