UMDNJ's clinical research enterprise

Roy S. Chaleff, PhD,
Acting Vice President for Research and Editor

In recent years medical science has been transformed by the development of powerful new technologies that have raised our expectations for the discovery of ever more effective therapies. Yet the attention commanded by exciting breakthroughs in the early stages of medical discovery may cause us to overlook the equally important contributions of the later phases, which involve extensive testing on human subjects to ensure the safety and efficacy of new therapeutics and medical devices. Such tests, known as clinical trials, are based on a cooperative and trusting partnership between investigators, the community, and sponsors. This successful partnership, built up over many years, is but one of many exceptional features that distinguish the UMDNJ clinical research enterprise.

This issue of UMDNJ Research introduces you to several faculty investigators conducting clinical trials funded by biomedical companies. The individuals presented in this issue were selected to portray the breadth of research activity at UMDNJ and are only a sampling of the University's many clinicians engaged in industry-sponsored clinical research. A subsequent issue of UMDNJ Research will feature examples of university investigators whose clinical research is supported by government funding.

As New Jersey's health sciences university and the largest free-standing medical sciences university in the nation, UMDNJ supports a large and diverse clinical research enterprise that includes three medical schools, a dental school, five university hospitals, and affiliations with more than 70 New Jersey hospitals and/or health systems. UMDNJ investigators currently oversee nearly 900 active clinical trials, approximately 40% of which are funded by corporations, spanning an extremely wide range of therapeutic areas, including ophthalmology, oncology, cardiology, neurology, endocrinology, gastroenterology, urology, psychiatry, and infectious disease.

Recently UMDNJ introduced two innovations to enable the pharmaceutical and medical device industry to take fuller advantage of the University's extensive clinical research capabilities. First, to facilitate access to UMDNJ's clinical research programs and resources, the University developed a new website (clinicaltrials.umdnj.edu) that provides information about clinical trials tailored to an individual's interests or "viewpoint." By entering the website as a member of the public or as a healthcare provider, one may find open clinical trials and information for enrolling. A company representative interested in sponsoring a clinical trial can search for UMDNJ investigators with expertise in particular diseases or conditions and can review investigator profiles, credentials, and contact information. The website also enables potential sponsors to view pertinent University policies and sample agreements when working with UMDNJ. University investigators will find the website useful as a resource for policies and procedures governing human subjects research and to locate collaborators with similar or complementary research interests.

Second, UMDNJ has supplemented the resources of its own internal Institutional Review Boards (IRBs) by contracting with Western IRB, an accredited, independent IRB, for review of industry-sponsored protocols. Western is the largest and most experienced independent IRB in the U.S. and is engaged by other prestigious medical research institutions, such as Yale, Columbia, and Johns Hopkins universities. The addition of Western IRB's services is expected to reduce turnaround time for approval of research protocols, especially in cases where UMDNJ is a participant in a multi-site trial.

We believe that these measures, which were taken to improve the administrative efficiency and responsiveness of UMDNJ's clinical research enterprise, will increase opportunities for collaboration and enhance the University's ability to assist industry in translating promising new medical discoveries into approved therapies that benefit public health. §