Industry-sponsored Clinical Research Research Articles

Ten Steps to Developing a National Agenda to Address Financial Conflicts of Interest in Industry Sponsored Clinical Research

Financial liaisons between clinical researchers, research institutions, and industrial sponsors have gained momentum in recent years. In the process, it has been argued by many that trust in the research infrastructure is being eroded by the financial conflicts of interest that emerge from these arrangements. Yet, the financial resources of industry are needed to continue technology transfer from the bench to the bedside. Policy makers and government regulators are currently struggling to determine how to best manage financial conflicts of interest that emerge from these liaisons. Various organizations and governmental entities have proposed different strategies. This paper explores the limitations of existing measures and recommends that a unified national agenda is needed. We propose 10 steps to develop an agenda to address financial conflicts of interest in industry-sponsored clinical research. Supported by National Institutes of Health/National Library of Medicine, Project number: 1G13LM07J12-01.

Budget negotiation for industry-sponsored clinical trials.

The specialty of anesthesia is well suited to attract industry-sponsored clinical trials and research revenues because of its fundamental contributions to surgery, critical care, and pain medicine. However, the performance and budgeting of industry-sponsored clinical research over the past decade has been significantly altered by the rapid growth of commercially oriented networks of contract-research organizations and site-management organizations. Further, the competitive nature of today's clinical research climate can make the planning and negotiating of study budgets and contracts stressful, time consuming, frustrating, and full of pitfalls. Because a clinical trial contract is a fixed-price agreement, investigators are obligated to perform the work described in the contract, even if the actual costs exceed the study contract. Successful budgeting for the performance of an industry-sponsored clinical trial thus requires a thorough understanding of the direct and indirect costs associated with performing clinical research. We reviewed budget and contractual considerations for the successful negotiation and performance of industry-sponsored clinical research.

Emergency medicine leadership in industry-sponsored clinical trials.

To identify and characterize emergency medicine (EM) researchers who, since 1990, have served on a steering committee (SC) or as overall principal investigator (PI) of an industry-sponsored, multicenter clinical trial involving a pharmaceutical or device. North American EM research directors (RDs) and other prominent EM investigators (for those hospitals without a RD) were identified from eight sources, including the Society for Academic Emergency Medicine RD Interest Group and the Multicenter Airway Research Collaboration (MARC) database. The identified investigators were sent a screening survey requesting information regarding industry-sponsored clinical research at their site. The individual EM investigators identified by this screening survey were then interviewed by telephone (validation survey) to further explore their leadership experience in industry-sponsored clinical trials. Of 153 identified RDs and prominent EM researchers, 138 responded to the screening survey (90% response rate). Eighty-five EM investigators reportedly had served on a SC or as overall PI for an industry-sponsored clinical trial. Of these 85 North American EM investigators, 77 were available for a structured telephone interview (91% response rate). Although 41 (53%) of the investigators confirmed their leadership role, 36 (47%) had not served in either role. Among the 41 confirmed investigators, 19 (25%) had served as a SC member, 10 (13%) had served as overall PI, and 12 (16%) had experience in both roles. Individual responses provided suggestions for pursuing such leadership positions. These data suggest the opportunity to expand EM leadership in industry-sponsored clinical trials and demonstrate the need for validation of reports obtained by a departmental research contact. The suggestions from EM researchers who have attained these leadership roles may provide strategies for investigators interested in pursuing these positions.

Establishment of a clinical trials office at a children's hospital.

To create a clinical trials office (CTO) at a children's hospital and assess its impact. Meetings with faculty and clinical trials groups were undertaken to develop a conceptual plan for an exclusively pediatric CTO designed to be a 1-stop office for sponsors, contract research organizations, and investigators. Guiding principles, eg, use of the CTO would be voluntary and paid for on a fee-for-service basis, were defined, and a business plan was developed. The CTO opened in October 1997, offering a broad menu of services. Initial marketing efforts have been followed by steadily increasing use of the CTO, measured in a number of studies and investigators who use CTO services. Commensurate growth in CTO staffing has been required. Since the CTO's opening, the number of and revenues from industry-sponsored clinical trials performed at the hospital have been significantly greater than the pre-CTO baseline and have exceeded business plan projections. In addition, the proportion of industry-sponsored clinical research at the hospital that is administered by the CTO has expanded (now >50%). The increase in hospital revenues from industry-sponsored clinical trials has exceeded the cost of running the CTO. Studies performed by the CTO have involved a mix of general pediatric clinic/private office patients, subspecialty clinic patients, and hospitalized children. A CTO dedicated to pediatric clinical research can enhance the ability of a children's hospital to participate in the growing number of pediatric clinical trials.

Maintaining integrity and credibility in industry-sponsored clinical research

There have been recent, heightened concerns about the integrity and credibility of industry-sponsored clinical research. While attributable to a variety of factors, the potential consequences are a decrease in the ability of the biomedical research enterprise to produce innovative methods for the diagnosis and treatment of disease, with possible adverse implications for the health and well-being of the public. A specific example of a recent industry-sponsored clinical trial is presented as an approach to attempt to avoid any suggestion of fraud, error, or biased interpretation, in a way in which the integrity of the process will not be called into question and the credibility of the results will be maximized.