The Development of a Successful Pre-Award Infrastructure within a Climate Where Clinical Trials Sponsored by Pharmaceutical Industry Have Decreased since 2001-A Large Multi-Specialty Academic Medical Center Case Study

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Introduction: The Shape of Research

The landscape of research is constantly changing, and by its very nature is characterized by changing systems, procedures, and new technology (Murray, McAdam, Burke 2004). Investigative sites and investigators must have foresight and flexibility to participate competitively. Industry-funded research is a multi-billion dollar business. Pharmaceutical and device companies are extending boundaries into peri- and post-approval activities. More companies are going abroad for clinical trial sites as financial considerations make decreasing pre-clinical costs imperative. By going abroad, pharmaceutical companies find sites that will accept lower payment for research in order to secure a study. Fewer regulations, because of the absence of regulatory oversight agencies such as the Food and Drug Administration (FDA), simplify conduct of the research. Sites abroad also have larger potential subject pools (Shah, 2003).

In a business where, according to industry estimates, a single day's delay in bringing a drug to market can cost as much as $1.3 million, finding a ready source of trial subjects is an advantage (Rowland, 2004). This atmosphere demands that research sites develop and showcase their increased success rates in subject recruitment and retention; accurate, timely data; diverse subject population, and institutional resources, thus ensuring their identity as a niche provider among their competitors. Sites in the United States (U.S.) defend their subject costs by providing quality centered on the Iron Triangle of research. The Iron Triangle (Figure 1) is composed of three points: Good, Fast, and Cheap. When conducting research one can achieve any two of these, but never all three. (Chasse, 2004) In the U.S., one can get data Good and Fast, but not Cheap. Abroad, one can get data that are Fast and Cheap, but not Good, or Good and Cheap, but not Fast. Data obtained in this manner jeopardize the integrity of study results, as information could be inaccurate or not provided expeditiously.

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To become successful niche providers, sites must think "outside the box" of historical site management infrastructures. This case study highlights a successful model for pre-award within a large, multi-specialty academic medical center involved in multi-partite research activities ranging from bench research and animal studies to human trials. The model allows for abbreviated timelines on contract and budget negotiation and execution, enabling viability within a highly competitive marketplace. A Circle of Support (Figure 2) is a strategic plan focusing on customer service and satisfaction, which provides resources necessary for expeditious pre-award processes. Beginning with an entry portal, this dynamic schema illustrates a fluid representation of resources such as feasibility, biostatistics, information systems, budget development and negotiation, and legal review. Additional institutional resources can be pulled into the circle as necessary. Outside of pre-award, examples of institutional resources utilized are regulatory review board (Institutional Review Board) and post-award. With increased scrutiny (Congressional and otherwise) of research ethics, financial management, and conflict of interest, the centralization of the pre-award infrastructure allows for establishment of controls to address these issues. In an industry fraught with opportunities for improvement, geometric consideration of available resource allocation is an exciting concept application (Figure 3).

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According to the May 4, 2005, Kaiser Daily Health Policy Report, the number of clinical trials sponsored by the pharmaceutical industry has decreased "significantly" since 2001, and the number of principal investigators for trials in the U.S. has "declined even more steeply." These results are reflected in a study conducted by the Tufts Center for the Study of Drug Development and reported in the Washington Post (Kaiser Daily Health Policy Report, 2005). …