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.

Principal Investigators

The principle investigator(s) functions as the disease-specific reviewer of the protocol and is expected to provide key input into the study design as it relates to enrollment and treatment of patients in the study. MPAnalytics can provide virtual PI services for your clinical trial with expert assistance on design strategy (even considering reimbursement issues as part of the design), design review, and “hands-on” support as needed.

Critical Questions for Clinical Trial Design

Critical questions that must be answered include:

1. Is the study designed in a way that patients will be interested in participation and investigators will be interested in participation?
2. Are the inclusion/exclusion criteria properly designed to enroll patients that will provide a fair test of the device/product to achieve the study outcomes?
3. Based on the inclusion/exclusion criteria and the number of centers included, will patient enrollment allow study completion in a reasonable time frame?
4. Is the primary outcome measure the best one for this clinical area?
5. How will the potential outcomes of this study determine the next step in device development?

Unfortunately, many principle investigators selected on the basis of their national prominence in their field have little training in clinical trial methodology, design or statistics, and are poorly equipped to assist with many of these questions. In other cases, while experienced, they are too busy to devote the time required to review the protocol in the detail required to provide proper guidance in study development.