University-Pharmaceutical Industry Cooperation: Creation of a New Administrative Position to Broker the Placement of Clinical Trials

Article excerpt

UNIVERSITY--PHARMACEUTICAL INDUSTRY COOPERATION: CREATION OF A NEW ADMINISTRATIVE POSITION TO BROKER THE PLACEMENT OF CLINICAL TRIALS

Abstract

A two-year pilot program was implemented by the Office of Research Administration (ORA) at the University of Missouri-Kansas City (UMKC) to increase receipt of sponsored industrial funds for clinical research conducted within various health science units and affiliated hospitals. This program entailed creation of a new, part-time administrative position (Assistant Director, Clinical Trials) within ORA to enhance UMKC--pharmaceutical industry cooperative ventures. The Assistant Director was specifically charged to broker placement of clinical/industrial trials among academic units with interdisciplinary research programs in the health sciences. Following a two-year period of continuous operation, this new endeavor has resulted in placement of five clinical/industrial studies worth $448,698. In addition, two protocols are pending; their combined budgets total $218,002. This new program has been successful in improving levels of sponsored funding in an institution with health science components.

Introduction

The current literature contains data addressing some of the institutional factors and components needed to improve prospects for acquisition of sponsored research funding.[1,2] In this regard, several reports have described methods to increase faculty participation in sponsored activities, eg., creation of grant development seminars,[3,4] means to disseminate relevant agency/program information,[4,5] improved and directed use of internal research grants[6,7] and development of institutional-based sponsored funding searches.[8,9] One institutional Research Administration Office developed a new sub-unit to concentrate on solicitation of sponsored funds from private foundations[10] The Office of Research Administration (ORA) at the University of Missouri-Kansas City (UMKC), has implemented a new program to solicit sponsored industrial funds for a specific and targeted area; namely, interdisciplinary research in the health sciences. Presently, UMKC has a large comprehensive health sciences component, including Schools of Basic Life Sciences, Dentistry, Medicine, Pharmacy and Nursing, in addition to several participating/affiliated hospitals (e.g., Children's Mercy Hospital, Truman Medical Center and Veterans Administration Medical Center). These health science units provide a suitable environment for cooperative ventures with the pharmaceutical industry.

Prior to initiating the present program, ORA played a somewhat passive role in acquiring sponsored funds on behalf of health science units, i.e., support activities associated with the pre-award, and post-award process(es). In 1986, ORA assumed a more active posture, by creating a new, part-time administrative position (Assistant Director, Clinical Trials) to `broker' placement of clinical/industrial trials among various health science units.

The results achieved, two-years following creation of this new position within ORA, are presented. The success of this new venture can be defined, not only by number of clinical/industrial studies placed and total sponsored funds received from industry, but also by a greater than 90% attempts-to-successful placements ratio.

Administrative Function and Position Description

The capacity to successfully broker the placement of clinical/industrial trials is highly dependent on construction of appropriate administrative functions to facilitate university--pharmaceutical industry cooperative ventures.[11] In this arena, ORA dealt with four such major administrative functions: (1) refining industrial contracting and budgeting processes; (2) improving institutional review board (IRB) mechanism to provide timely assessment and approval of clinical/industrial study protocols; (3) establishing new contractual relationships with participating/affiliated hospitals; and (4) instituting a clinical service fee (if appropriate) as a means to support salary and expenses associated with the new administrative position. …