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What is a Clinical Research Trial?

Clinical research trials are monitored research studies of new medications or treatments to assess their efficacy and safety for use in humans. Each clinical trial is intended to answer precise scientific questions in order to discover innovative and improved manners to help patients suffering from various medical conditions. A clinical trial may:

  • Determine the first effective treatment
  • Identify a more effective treatment
  • Discover a better tolerated treatment
  • Confirm a new use for an existing treatment

Four Phases of Clinical Trials

The four types of clinical trials are Phase I, Phase II, Phase III and Phase IV. Phase I clinical trials test new drugs on healthy volunteers to determine safety, dosing, efficacy and tolerability of certain medications or treatments. Participants in Phase I trials are required to be in-patients for varying lengths of time.

Following the Phase I trial, provided the new drug has been proven safe, Phase II trials are initiated. Phase II clinical trials require a larger group of volunteers of patients who are afflicted with the targeted condition. Phase II trials test for efficacy, toxicity and safety. If the treatment makes it to Phase III, large groups of participants are tested across numerous trial centers to confirm the treatment’s efficacy and to identify any side effects, whether positive or negative. Phase IV trials are conducted after the drug has been marketed to further determine any benefits and/or risks.

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 FAQ’s on Clinical Trials:

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