A B S T R A C T PurposeInconsistencies and errors resulting from nonstandard processes, together with redundancies, rework, and excess workload, lead to extended time frames for clinical trial protocol development. This results in dissatisfaction among sponsors, investigators, and staff and restricts the availability of novel treatment options for patients. MethodsA team of experts from Mayo Clinic formed, including Protocol Development Unit staff and management from the three Mayo Clinic campuses (Florida, Minnesota, and Arizona), a systems and procedures analyst, a quality office analyst, and two physician members to address the identified deficiencies. The current-state process was intensively reviewed, and improvement steps were taken to accelerate the development and approval of cancer-related clinical trials. The primary goal was to decrease the time from receipt of a new protocol through submission to an approving authority, such as the National Cancer Institute or institutional review board. ResultsUsing the Define, Measure, Analyze, Improve, Control (DMAIC) framework infused with Lean waste-reduction methodologies, areas were identified for improvement, including enhancing first-time quality and processing new studies on a first-in/first-out basis. The project was successful in improving the mean turnaround time for internally authored protocols (P Ͻ .001) from 25.00 weeks (n ϭ 41; range, 3.43 to 94.14 weeks) to 10.15 weeks (n ϭ 14; range, 4.00 to 22.14 weeks). The mean turnaround time for externally authored protocols was improved (P Ͻ .001) from 20.61 weeks (n ϭ 85; range, 3.29 to 108.57 weeks) to 7.79 weeks (n ϭ 50; range, 2.00 to 20.86 weeks). ConclusionDMAIC framework combined with Lean methodologies is an effective tool to structure the definition, planning, analysis, and implementation of significant process changes.

The Institute of Medicine and US Food and Drug Administration (FDA) recognize that activating clinical trials in the United States is lengthy and inefficient. Downstream consequences include increased expense, suboptimal accrual, move of clinical trials overseas, and delayed availability of treatments for patients. An in-tandem processing initiative is here highlighted that transformed the activation of clinical trials (TACT), reduced the activation time by 70%, and offers a paradigm for enhanced translational readiness. TRANSFORMING THE PROCESSNational academies and regulatory agencies have identified a major need in expediting the launch of clinical trials to ensure an optimized, competitive, and cost-effective translational process. 1,2 A plan-do-study-act (PDSA) process, 3 Design for Six Sigma, and Lean 3P methodologies were used to redesign the entire process (Table 1), which was tested in selected pilot trials, then implemented institution-wide (final phase) at Mayo Clinic sites in Rochester, Minnesota, Jacksonville, Florida, and Scottsdale, Arizona. The project was limited to industry-funded trials, where process flows, activation timelines, and funding are more predictable than federally sponsored trials.The fundamental change was a process in which the financial, contractual, and regulatory steps occur in parallel rather than in series (Figure 1). Other changes were the creation of integrated work teams, less complexity, improved quality, more effective communication among business units, and the elimination of redundant work, barriers, and waste while ensuring that protection of research participants remained the leading priority. Every trial had a facilitator, i.e., a project manager, who ensured, at the outset, that the sponsor and study teams were committed to the process and timeline. Most studies (accelerated clinical trial; ACT1 studies, 38 of 40 pilot and 71 of 105 final trials) adhered to a 65-day timeline. For the remaining (ACT2) studies, the actual timeline was negotiated on a case-by-case basis with study sponsors. Extensive face-to-face training and new electronic tools were provided to all participants. For all trials, the total time for all steps from submission of the funding proposal to account creation was measured in calendar days (Figure 1). During the pilot phase, the actual work time was also measured. EXPEDITED OUTCOMESBefore TACT, the median (interquartile range (IQR)) activation times were 189 (134-264) calendar days in 2013 (277 trials), 166 (126-251) days in 2014 (296 trials), and 168 (123-244) days in 2015 (333 trials). By comparison, 109 ACT1 trials were activated in 59 (43-63 days, P < 0.001). Of these 109 trials, 91 were drug trials, 17 included a device, and one evaluated a behavioral intervention. Among drug studies, 17 were phase I, 10 were phase I-II, 34 were phase II, one was phase II-III, 24 were phase III, and five were phase IV studies. The 34 ACT2 studies were activated in 63 (49-95) days. It took longer (P 5 0.002) for studies to be activated at two or three May...

Background The translation of biomedical research discoveries into clinical practice is marked by extended timelines (averaging 17 years) and multiple sequential process steps. However, even after a drug, device, diagnostic tool or unique therapeutic procedure successfully navigates through clinical testing to approval, real barriers remain in applying and scaling the innovation in practice. Methods Mayo Clinic initiated the Transform the Practice programme to facilitate multidisciplinary team and convergence science to continuously reinvent solutions to address unmet patient needs and accelerate the application of next-generation healthcare solutions. During a 5-year period, 24 programme teams received financial resources, barrier-removing engagement from clinical and research leadership, and enhanced administrative support, including dedicated project managers. Results The approach created value in facilitating consistent progress toward project objectives and resulted in multiple publications, new extramural funding sources, and implementation of new tests and services into the clinical practice. This report describes the concentrated institutional effort to accelerate the discovery–translation–application continuum in an academic medical centre and highlights successful applications and persistent obstacles. Conclusions The Transform the Practice approach is effective in moving high-potential research discoveries closer to implementation in the clinical practice. Its concepts, including the application of structured project management methodology, may be quickly integrated to shorten an organisation’s time to implementing its most important discoveries.