A Novel Approach to Overcoming Barriers to Clinical Research

Summary and Conclusions The concept of protocol navigation has been previously reported in the literature; 12 yet, tothe best of our knowledge, the NIAID PDP is uniquely structured, making use of specializedgroups, such as protocol navigators and medical writers, in the context of additional supportprovided by clinical trials management, regulatory, and safety oversight teams. Collectively,these groups offer a multidisciplinary level of expertise, working together to address theadequacy of resources within NIAID.Different approaches have been explored on ways to identify, measure, and targetimpediments curtailing the success of clinical research. 5,6,9,12,13 Our program uses processmapping, milestones, key performance indicators, and a feedback tool to measure theperformance output, productivity, and quality of the services provided. By looking atparameters such as the volume of protocols supported and stipulations received during aspecific time period, and the average cycle times for the different metrics used, thecapabilities of the program will continue to be refined to achieve the best possible outcome.Since the process-mapping exercise was completed, the protocol development process hasbeen further streamlined to enhance efficiency. For instance, concurrent submissions to thescientific and pre-IRB reviews have shortened the timeline between the scientific reviewapproval and submission to the IRB. Responding to concerns earlier in the process hasproven beneficial and, in many cases, has eliminated the need for a second pre-IRB review.In contrast, studies not using the PDP could be delayed during the pre-IRB review due tounforeseen or unresolved issues.The PDP has facilitated the development of 30 new studies through 2011, spanning a widerange of clinical phases and laboratories within NIAID. Thirty percent of the studiesapproved by the NIAID IRB in 2010 and 38% approved in 2011 were supported by the PDP.Additionally, the PDP has provided assistance with amendments, which consist of extensiverevisions to the protocol and consent documents.Preliminary results from the feedback tool are encouraging, suggesting that the program hashad a positive effect on those using its services. The majority of the respondents were first-time users of PDP services who completed two to five studies as lead investigators, and hadfive years or less of experience in conducting clinical research at the NIH. The primaryreasons for using PDP services were to receive assistance with drafting the protocol andconsent documents, to hasten the approval process, and for support due to a lack ofresources.These results mirror the findings from the 2007 survey, which highlighted adequacy ofresources and the approval process as main barriers to clinical research at the NIH. The highoverall satisfaction scores and positive responses provided in the narrative portion of thefeedback tool support the idea that our program fulfills an unmet need for NIAID intramuralinvestigators.The PDP organizational structure and scope of services can be adapted to fit the individualneeds of other institutions. Seeking input from researchers throughout the process andensuring management support are essential to the successful implementation of a program.Undoubtedly, barriers to clinical research will ensue during a program’s implementationphase; however, clinical research professionals and institutions must evolve through theprocess by overcoming barriers with innovation and a commitment to getting research donein the most efficient manner possible.