What are Phase 3 (III) Clinical Trials?

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Phase 3 Clinical trials are long term studies that involve a large volume of subjects from across the demographic strata

Phase iii (3 or III) clinical trials are probably the most commonly encountered type of clinical trials by patients (thats because they are large clinical trials). If you have always be puzzled by what the different are the various phases of a clinical trial, and how they differ, then hopefully this post will answer some of your questions.

Phase 3 clinical trials are usually multi-center clinical trials that may recruit hundreds to tens of thousands of patients. They are time-consuming, expensive and at times difficult to complete on time, but are critical for final approval of the drug or device. Though, not a mandate, the FDA usually requires at least 2 successful phase 3 clinical trials for considering a treatment or drug for approval.

The phase iii clinical trials are designed to fulfill several research goals including but not limited to:

Establish long term safety of the treatment, for this reason, most phase 3 trials are long term trials that may carry on for several years.
Establish the efficacy and safety of the treatment and its dosage across the demography, including the different sexes, ethnicities, age groups, etc. For this reason, these research studies include large numbers of participants.
Establish or rather compare the benefits and risks of the new treatment with those of the established and presently available treatment options, the prevailing ‘gold standard’ available to treat the given medical condition.

Phase 3 trials may also be conducted on approved drugs to verify the expanded usage of the study treatment, meaning, to evaluate whether the drug is effective in patients for who may not form the target group of the drug. For instance, an anti cancer drug might initially have been approved for use on stage 1 cancer patients only. However, if the drug manufacturers feel that it might be effective in stage 2 cancer patients or cancer patients with other complications, then the drug might be moved to phase 3 clinical trial to establish its efficacy in treating the new target group.

Phase 3 trials usually involve minimum health risks. Such trials may also provide participants some compensation for their time and for travel expenses. And they also serve as a good alternative for several patients to receive free health care (irrespective of medical insurance).

If you are interested in participating in one of the phase 3 clinical trials then get a complete trial listing by searching for phase 3 clinical trials. Here are a few useful links for phase 3 diabetes trials, phase 3 pancreatic cancer trials, and Multiple Myeloma Phase 3 clinical trials .