The SRA Symposium - College of Medicine

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Papers How to Develop a Centralized Pre-award Infrastructure Successfully Within a Climate Where the Number of Clinical Trials Sponsored by Pharmaceutical Industry Has Decreased Since 2001 – A Large Multi-Specialty Academic Medical Center Perspective Theresa Ann Strakos, BSHSc., CCRP, CRCPA Felicia Ann Riney, MBA, CRCPA Research & Education Division - Grants Administration Department Scott and White Memorial Hospital and Scott, Sherwood and Brindley Foundation 2401 South 31st Street Temple, Texas 76508 USA 254.724.5818 tstrakos@swmail.sw.org friney@swmail.sw.org Edited by: Julia Blackwell, BS; her efforts were tireless and her contributions immeasurable. ABSTRACT In today’s research arena, protracted contract and budget negotiations are leading to pharmaceutical and device companies seeking sites and services abroad. Our presentation 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. One cannot have management without measurement, thus institutional benchmarking is imperative. Utilizing the suggested 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 a square or a circle. Squares limit the number and flow of resources, which leads to fragmentation. Circular institutions 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 it to be applicable to any organization. What Shape Are You? INTRODUCTION 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 and more companies are going abroad for clinical trial sites because drug developers try to decrease costs by decreasing pre-clinical costs. By going abroad, pharmaceutical companies can look for sites that will accept lower payment for research in order to secure a study at their site. 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). 248 2005 Symposium Proceedings Book
Papers In a business where every day’s delay in bringing a drug to market can cost as much as $1.3 million, according to industry estimates, finding a ready source of trial patients is an advantage (Rowland, 2004). This atmosphere demands that research sites develop and showcase their increased success rates in patient recruitment and retention, accurate timely data, diverse patient population and institutional resources; thus ensuring their identity as a niche provider among competing research sites. Sites in the United States (U.S.) defend their patient costs by providing quality centered around what is referred to as the “Iron Triangle” of research. The “Iron Triangle” (Figure 1) of research is composed of three points: Good, Fast, and Cheap. When conducting research one can manage any two of these, but one can never get all three. In the U.S., one can get data “Good and Fast,” but not “Cheap.” Abroad, one can get data that is “Fast and Cheap,” but not “Good,” or “Good and Cheap,” but not “Fast.” Data obtained in this manner will jeopardize the integrity of the study results, because information would be inaccurate or not provided expeditiously. In order to become a successful niche provider, sites must think “outside the box” of historical site management infrastructures. The focus of our presentation is the sharing of 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. This 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 (Internal 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, “Don’t Try to Fit a Square Peg in a Round Hole!” (Figure 3) According to information provided in 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 United States 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). Using information collected by the FDA, researchers at Tufts found that after a major expansion during the 1990s, the number of drug industry-sponsored clinical trials leveled off in 2000 and began to drop after 2002. The number of principal investigators for trials in the Unites States decreased by 11% between 2001 and 2003, and the number of trials abroad increased by 8%. Discontinuation of trials before they reach their final phase has contributed greatly to the decrease. In addition, trials are becoming less lucrative for doctors and researchers, thus more trials are being conducted at cheaper sites abroad. Researchers interested in participating in research are frustrated by increased costs, poor communication and fragmented organizational infrastructures. The work of Kenneth Getz (2005) reflects that new clinical trials are increasingly being done abroad. Statistics show that the number of American sites where clinical trials were underway declined from about 51,000 in 2001 to 48,000 in 2003. During that same period, the number of FDA-approved investigational drug studies in all phases of research rose from about 3,900 to 4,500 but with less research being done at U.S. sites (Kaiser Daily Health Policy Report, 2005). Although ongoing clinical trials in the United States are generally not being moved overseas, the lower costs abroad and the often greater professional and public interest are leading many companies to set up new trials in Eastern Europe, South America and India. (Kaiser Daily Health Policy Report) 2005 Symposium Proceedings Book 249
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2005 Symposium Proceedings The SRA
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Dear Colleagues and Friends, Octobe
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Table of Contents Karen M. Wilson.
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Poster Abstracts
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Poster Abstracts Poster Abstract 20
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Poster Abstracts Contributed Poster
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Papers
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Papers The principles of respect fo
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Papers The narrative approach, on t
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Papers References Agre, P., Campbel
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Papers Potts, A., Grace, V., Gavey,
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Papers Introduction Day by day soci
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Papers Brent: Karl has been a great
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Papers Karl: During my time at the
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Papers Work Hard. Another very impo
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Papers External Resource Acquisitio
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Papers Generally speaking, fundrais
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Papers Organizations and websites t
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Papers Public HBCUs and smaller chu
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Papers There are key databases avai
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Papers 2. Basic Institutional Compo
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Papers The Utility of Gender, Race,
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Papers As a three hospital health c
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Papers References Amdur, R., Banker
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Papers • Dramatic Growth in Resea
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Papers • Cross Unit Collaboration
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Papers The Development, Implementat
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Papers Background: IRBs in AMCs hav
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Papers Institutional Quality Improv
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Papers Institutional Audit Findings
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Papers References: Burke, G.S. (200
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Papers Table 1 Total Number of Prot
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Papers Sunday, December 7, 2003. D
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Papers Similarly, the OGE audit ind
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Papers Changes to 5 C.F.R. §5501.1
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Papers * * * However, § 5501.106(c
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Papers 4. Conclusion The NIH Februa
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Papers Within the context of a mana
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Papers As illustrated (Figure 1) th
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Papers Figure 3. Recommendation lev
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Papers References Australian Vice-C
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Papers The Problem and Its Statemen
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Papers ated directly or indirectly
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Papers Table 1: Survey Respondents
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Papers Conclusions With the creatio
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Papers APPENDIX 2 I. Research Admin
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Papers facing patients being recrui
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Papers Even if prospective subjects
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Papers sponsors must have some idea
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Papers 4) Heuristics: Since the con
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Papers Hochhauser, M. Informed Cons
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Papers How “readable” are conse
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Papers of vowels per word, some on
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Papers followed by 39 side effect b
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Papers References Chall, J.S. & Dal
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Papers Coping involves the effort t
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Papers Conclusion Defense mechanism
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Papers of Pennsylvania in 2000. In
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Papers for board members, reviewing
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Papers Focusing on “Development
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Papers Figure 1: Total UB Internal
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Papers Figure 3: Academic staff vie
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Papers Respondents’ evaluations o
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Papers 140 2005 Symposium Proceedin
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Papers ing proposals, the greater t
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Papers Abstract “Best Practices
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Papers INSTITUTIONAL ERA PLANNING A
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Papers process than an end product;
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Papers realization of the benefits
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Papers State and private institutio
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Papers Institutions of higher educa
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Papers Typically, all interactions
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Papers Figure 2 There are nine pers
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Papers Questions that can be discus
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Papers Using the innovation success
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Papers students in non-science subj
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Papers For example, to address inno
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Papers The second is the Botswana T
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Papers manpower is not trained, and
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Papers European and Federal Funding
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Papers As the majority of US Univer
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Papers Integrated Project Duration
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Papers Collective responsibility -
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Papers • Revised implementation p
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Papers Conclusion SRA is an interna
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Papers and in which disciplines. Th
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Papers a historically black univers
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Papers Benefits of Working with Jun
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Papers Human Subjects Research and
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Papers observational and could do v
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