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The increasing trend toward conducting clinical trials outside the United States is an important consideration in discussing ways to improve the efficiency of trials. The number of patients enrolled in clinical trials is decreasing in the United States and increasing abroad. According to Woodcock, when development programs are conducted entirely outside the United States, the FDA questions the extent to which the results can be translated to U.S. clinical practice. The applicability of foreign trials results depends on the disease being studied and the state of current clinical practice in that area. 

Clinical trial costs can vary widely depending on the number of patients being sought, the number and location of research sites, the complexity of the trial protocol, and the reimbursement provided to investigators. The total cost can reach $300—$600 million to implement, conduct, and monitor a large, multicenter trial to completion. A large, global clinical trial usually adds up to about $300 million.

The internal requirements of an academic institution, federal agency, or pharmaceutical company for reviewing multiple aspects of a clinical trial can significantly delay its initiation. In the case of an academic institution conducting a clinical trial for a pharmaceutical company, the internal review processes of both organizations are involved. In addition to such internal requirements, myriad federal and state regulatory requirements affect the conduct of clinical trials. Adhering to these many requirements is a significant challenge for investigators. Moreover, the delays incurred increase the time cost of a trial and decrease its overall efficiency. U.S. academic institutions typically take longer to navigate the approval process (i.e., from budget/contract to IRB approval) compared to private or academic institutions abroad. The protracted timeline to approve a clinical trial through U.S. institutions is one reason industry sponsors look outside the United States to initiate studies.

Administrative burdens are not always imposed on investigators by external laws and regulations. As Lane noted, many bottlenecks arise internally and are imposed by institutions that are home to the research workforce. In the government-sponsored Occluded Artery Trial (OAT), for instance, it took 3 years from the first NIH steering committee meeting to the start of the trial. Because clinical research relies on substantial human effort that incurs large labor costs, the timeline for a clinical trial affects overall cost. DiMasi and colleagues estimated that in 2000, the average cost to develop a new drug was $802 million, and time costs associated with the length of research and development accounted for half of this cost (DiMasi et al., 2003). For the pharmaceutical industry, protracted timelines increase cost and reduce revenue as medications typically have a finite life before losing patent protection and creating an opportunity for generic competitors. Moreover, when a trial addresses a question important for medical practice, increasing the time it takes to obtain an answer can reduce the impact of the results. Musa Mayer, breast cancer survivor, advocate, and author (, commented that if clinical trials are subject to significant delays, the standard of care can move on in the absence of phase III data. Thus, obstacles and delays in clinical trials move health care further away from evidence-based practice. Moreover, if the time lag is significant, the results of a lengthy, expensive trial may already have been rendered irrelevant by changes in clinical practice when they finally become available.

A core function of a successful clinical trial is finding patients who fit the predetermined eligibility criteria and getting them to participate. Each disease area addressed during the workshop (cardiovascular disease, depression, cancer, and diabetes) has a unique patient base for clinical trials, and the issues that affect patient enrollment in trials can vary according to features of the disease. In addition, workshop participants identified challenges to patient recruitment that transcend disease status.

According to Woodcock, sites for clinical trials are frequently selected on the basis of where the investigators are located, as opposed to where the patients are, creating difficulties in patient recruitment. When patient recruitment is impeded, the trial is delayed, sometimes by years, until the number of patients required by the study protocol can be enrolled. Once a trial protocol has been activated, the recruitment of patients requires a significant amount of time and money. Canetta reported that the ability to recruit patients into a trial successfully is similar for the pharmaceutical industry and NCI. Regardless of the trial sponsor, recruitment of patients who meet the requirements of the protocol is difficult: in one study of 14 cancer centers approximately 50 percent of study sites failed to recruit a single patient (Durivage et al., 2009). Thus, patient enrollment can directly affect the number of trials that are completed.