Use of recruitment networks in randomized trials: North American versus global.

T here is growing recognition among investigators, funding agencies, and other constituencies that the clinical trial enterprise in the United States is not keeping pace with our health system's need for more and better information to guide clinical decision making. 1 The need for better information is largely driven by the rapid pace of discovery in biology, technology, and health services delivery, which has yielded new medical capabilities that require testing before rationale clinical dissemination. The need for better information is also driven by an alarming rise in the cost of health care. Better research can help policymakers select services on the basis of value. The randomized clinical trial is the best source for unbi-ased information about the effectiveness of new therapies, diagnostic strategies, and health delivery innovations. Trials, however, have become expensive and inefficient in the United States, resulting in fewer investigators, unan-swered questions, and more of the work shifting to other countries. 2 It is not uncommon, furthermore, for randomized clinical trials to fail after initiation, resulting in unanswered questions, loss of initial investment, and unnecessary risk to participants. The causes of this failed enterprise include regulatory burden, lack of infrastructure, and a clinical culture that does not uniformly view research as a core mission in patient care. 2 Funding agencies and investigators are keenly interested in strategies to revive the clinical trial enterprise. Established methods include pretrial planning with attention to feasibility, inclusion of patients and advocacy groups to vet the research question, funding mechanisms that direct funds to sites with better performances, and oversight that allows early redesign or termination. A relatively new method is the clinical research network. This method and its variations are still in development but may expand our capacity to conduct highly efficient clinical trials in many areas of biomedical science. In this article, I elaborate on a recent taxonomy of clinical research networks 4 to describe their cardinal features. Multicenter clinical trials by definition comprise networks of participating sites. Newer network models are distinguished by features that improve control over process and allow multiple trials to operate simultaneously and sequentially. The following taxonomy of networks includes the conventional system that defines most large commercial trials and 3 more novel networks established by various funding agencies. This is the network used in most large trials, particularly large commercial trials (Figure 1). The convenience network is constructed for a specific trial and disbands …