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
Strakos, Theresa Ann, Riney, Felicia Ann, Journal of Research Administration
In today's research arena, protracted contract and budget negotiations lead pharmaceutical and device companies to seek sites and services abroad. The case study focuses on a successful pre-award infrastructure based on the Circle of Support model. A contract administration component is the central point of contact for activities relating to pharmaceutical and device studies. Implementation of this model allows for decreased timelines, increased productivity, improved customer satisfaction, and successful budget negotiation. Management without measurement is not quantitative; thus, institutional benchmarking is imperative. Utilizing a geometrically influenced pre-award model shows more dollars, more contracts, and higher indirect cost recovery establishing a decreased timeline for critical path resolution due to the centralized infrastructure. Implementation of the Circle of Support model and contracts administration component to decrease fragmentation among resources within an organization can achieve optimal results. Organizations tend to be either squares or circles. Squares limit the number and flow of resources, leading to fragmentation. Circles are all-inclusive, never-ending, and provide for unlimited flow of resources. Customers and stakeholders are thus surrounded by a fluid support system. The flexibility of this model allows for application to any organization involved in clinical research.
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.
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 multipartite 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. …