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Clinical Trials Overview

Core associates of MPA have extensive experience in the design and performance of clinical trials for novel medical devices at all stages. They understand that there are several keys to designing a clinical trial process for a device that will allow successful completion of the trial. This includes critical evaluation of the key outcome measures, intense scrutiny of inclusion/exclusion criteria and a sound statistical plan that will yield important clinical and safety results.

Currently, most companies developing the protocol for a clinical trial employ non-medical personnel to write the protocol followed by review by active clinicians in the field of study including the national principle investigator. Also, most companies employ a medical director at the company who is often involved in the study design. While the initial author of the study and the medical director at the company may be skilled in the format and requirements of clinical trial design, they generally have little clinically relevant experience in the area under study. The medical director may have performed clinical trials in other areas, but these experiences may be irrelevant to the enrollment and treatment of patients in the area under study.