Pilot studies for drug or device development are typically performed as a priori at the beginning of the process. They can be conducted when little or no clinical experience is available with the device or drug. Pilot studies refer to clinical trials that gather specific essential information about a device or drug before starting the pivotal trial. These trials will be used to make precise claims about safety and efficacy.
A pivotal study is a clinical test that attempts to show the efficacy of a new drug, and it can be used to gain marketing approval from the regulatory authority. A pivotal clinical study aims to demonstrate that a novel experimental drug is more efficient than an existing standard-of-care drug.