Advances in IT combined with business model transformation could combine to form a critical step in achieving transformation of the CTE through lower cost, faster, and better data quality of clinical trials according to a background paper prepared by Judith Kramer, Associate Professor of Medicine, Duke University Medical Center, and Executive Director, Clinical Trials Transformation Initiative (CTTI), Duke Translational Medicine Institute; and Kevin Schulman, Professor of Medicine, Duke University Medical Center, and Gregory and Jeremy Mario Professor of Business Administration, Fuqua School of Business. (See “Transforming the Economics of Clinical Trials” in Appendix F.) The entities involved in the conduct of clinical trials have not followed the cost-reduction trajectory of other technology-intensive industries and thus have not attained a business transformation sufficient to reap the economic benefits of technologic change. Instead, rapidly rising costs of U.S. clinical trials contribute to cost increases in developing innovative health products. For example, the estimated cost of developing one new drug has been suggested to range from $500 million to $2 billion (Adams and Brantner, 2006). The resulting high cost of conducting clinical trials constricts the pipeline for new drug development, limits the accretion of knowledge about drugs that are produced, deters a focus on innovation and improvements in trial design and conduct, and impedes the investigation of important public health inquiries.

Increasing costs stem in part from obstacles that exist within regulatory pathways or stem from administrative inefficiencies, including increasingly complex clinical trial protocols, abundant requirements issued by various levels of government and different governments and not harmonized to ensure consistency, and excessively risk-averse interpretations of regulations by trial sponsors. An example of the last is 100 percent source documentation of all clinical trial data even though regulators—both FDA and the European Medicines Agency (EMA)—do not require it. Some new structures, such as CROs, have arisen to help trial sponsors operate in the complex research environment. CROs are focused on efficiently conducting clinical trials according to current standards and client expectations and do not have as their mandate a goal of advancing innovation in clinical trial design and performance. According to some observers, CROs may improve efficiency for trial sponsors, but their business practices may also contribute to the current cost structure of clinical research.

According to the authors, new information technologies conceivably could alter the conduct of clinical trials. For instance, electronic data capture (EDC)—using a computerized system to gather clinical data in a clinical trial—has the potential to reduce total costs, prevent errors, and conserve the time expended by physicians, nurses, and data coordinators by replacing multiple paper entries on patients’ clinical progress with

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