Primer: establishing a clinical trial unit—obtaining studies and patients

Abstract

Rheumatologists with clinical expertise should perform clinical investigations of new molecules in an effort to discover therapies that could be of greater benefit or safety than those currently available for patients with chronic rheumatic diseases. Over the past few years, many studies have been conducted outside the United States and Europe because of the dearth of investigative sites in these countries. A clinician, whether in private practice or academia, who has the resources and desire to conduct clinical investigations, should be able to become involved in the process. The task of starting a new investigative unit is daunting, as it involves acquiring studies, hiring staff and obtaining space prior to any cash flow. If done properly, however, clinical investigation can be rewarding—both intellectually and financially.

Key Points

• The physician–investigator needs to pursue the acquisition of appropriate studies for the clinical trial unit aggressively

• The protocol must be carefully analyzed by the investigator to be certain the trial has a benefit for patients that outweighs the risk, that patients who will agree to enroll in the study and meet inclusion/exclusion criteria are available, and that the required procedures can be performed

• A fair and equitable contract with a reasonable indemnification and confidentiality clause, and which provides for a fair budget that is paid fairly, must be negotiated

• Methods to recruit suitable patients in an expeditious manner, preferably before the start of the study at the investigative site, need to be developed

• Performing the study well, adhering to good clinical practice, and enrolling at least the contracted number of patients all increase the chances of obtaining further studies from the sponsor