Pivotal study or Pivotal trial Definition & Meaning | Health Care Term | CSIMarket
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Glossary

Pivotal study or Pivotal trial

Health Care Term

A Pivotal study or Pivotal trial is a clinical trial conducted by pharmaceutical companies to obtain regulatory approval for a new drug or medical device. These studies are designed to demonstrate the safety and efficacy of the drug or device and to provide sufficient evidence for regulatory agencies such as the U.S. Food and Drug Administration (FDA) to approve the product for sale in the market.

Pivotal studies are usually performed after preliminary studies, and are often larger and more expensive. They typically involve a larger number of patients and are conducted over a longer period of time to obtain more robust data on the drug or device being tested. The primary endpoint of a pivotal trial is the measurable clinical result that the drug or device is intended to achieve, such as curing a disease or improving patient outcomes.

The results of pivotal studies are critical to pharmaceutical companies as they determine whether a product can be approved for marketing. Positive results from a pivotal trial can lead to regulatory approval, providing a considerable financial return on the investment made in developing the drug or device. On the other hand, negative results can mean significant losses for the pharmaceutical company, and may result in the product being rejected by regulatory agencies.

In summary, Pivotal studies or Pivotal trials are key to the development and approval of new drugs and medical devices. They demonstrate the safety and efficacy of a product and provide the necessary evidence to regulatory agencies for approval. Pivotal studies are critical to the pharmaceutical industry, as regulatory approval allows the company to market and sell their product, which can result in significant financial gains.


More Glossary Terms Beginning with P
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    Health Care Term Letter: P
  • Paid Development Method
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    Manufacturing Term Letter: P
  • Partial Remission PR
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    Health Care Term Letter: P
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    Manufacturing Term Letter: P
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    Manufacturing Term Letter: P
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    Transportation Term Letter: P
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    Transportation Term Letter: P
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    Transportation Term Letter: P
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    Immunologically active material transferred into the patient as a passive recipient. Monoclonal antibodies are considered Passive Immunotherapy since antibodies are generated outside the body and given to the patient
    Health Care Term Letter: P
  • Patent Term Extension
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    Health Care Term Letter: P
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