Streamlining and cycle time reduction of the startup phase of clinical trials

Abstract

Objective: The startup phase of a clinical trial (CT) plays a vital role in the execution of new drug development. Hence, the aim of this study is to identify the factors responsible for delaying the CT startup phase. Further, it focuses on streamlining and reducing the cycle time of the startup phase of newly sponsored CTs. Methods: Thirteen sponsored CTs conducted between 2016 and 2017 at the Clinical Research Department of King Fahad Medical City, Riyadh, Saudi Arabia, were considered for this study. Eight trials were analyzed to identify the data specific to startup metrics using the FOCUS-PDCA cycle (Find an improvement area-Organize a team-Clarify current practices-Understand the source of variation/problem-Select a Strategy-Plan-Do-Check-Act). Six measures incorporated in the metrics were (1) date of initial contact with site to the signing of confidentiality agreement, (2) date of receiving questionnaire from sponsor to date of its completion, (4) time taken to review protocol and approve investigational drug service form, and (5) time taken to study protocol and approve pharmacy and pathology and clinical laboratory medicine form and date of receipt of institutional review board (IRB) submission package to final IRB approval. Fishbone analysis was used to understand the potential causes of process variation. Mean (SD) time was calculated for each metric before and after implementation of the intervention protocol to analyze and compare percentage reduction in the mean cycle time of CTs. Data were represented as mean (SD), and the P value was calculated for each metric. The significance level was set at P < 0.05. Results: Of the various potential factors of delay identified through fishbone analysis, the two major ones were lack of a well-defined timeline for approval and review of the study protocol and inconsistent IRB meetings. After introduction of the new intervention protocol, the entire CT life cycle was reduced by 45.6% (mean [SD], 24.8 [8.2] weeks vs. 13.5 [11.6] weeks before and after the intervention, respectively). Conclusion: Various factors are responsible for the delay of the startup phase of CTs, and understanding the impact of each element allows for optimization and faster execution of the startup phase of CTs.

Assessment of North American Clinical Research Site Performance During the Start-up of Large Cardiovascular Clinical Trials

“…Krafcik et al described a 319-day median start-up time in a review of 38 heterogenous studies ranging from 2004 to 2016 in Boston, Massachusetts. Similarly, a 174-day start-up time across 13 Saudi clinical trials was reported by Abu-Shaheen et al, with a significant portion of that time dedicated to obtaining local IRB approval. To limit loss of resources spent on the contractual process without regulatory approval and vice versa, many institutions complete the regulatory approval process and contract negotiations consecutively rather than concurrently.…”

Clinical trial facilitators: A novel approach to support the execution of clinical research at the study site level

“…Delays in study start-up and the inability of clinical research studies to meet their targeted enrollment metrics can negatively affect the validity of study results, reduce their generalizability to the broader population by impacting study completion timelines, and subsequently influence the quality of trials for these reasons [ [24] , [25] , [26] , [27] , [28] , [29] ]. The literature surrounding the use of trial facilitators to guide assigned study sites through clinical trial start-up and enrollment phases is limited, and the use of facilitators in research settings is exclusively related to clinical care positions and/or teams that either primarily focus on developing research capacity and building research culture within organizations, or supporting the implementation of findings from trials into medical practices using unique, tailored intervention strategies [ 30 , 31 ].…”

Landscape of Guillain–Barré Syndrome Interventional Clinical Trials

“…25 Streamlining the launch phase will result in a shorter mean trial phase and faster IRB approval, resulting in better recruitment of subjects in the future through better activation phase planning and execution. 26 Integrating several subtrials to maximize accrual numbers and minimize logistical hassles is a one-of-a-kind way for master protocols to expedite the development of therapies and decrease futility. 27 Among the 21 trials registered on Clinicaltrials.gov, only 5 produced publications retrievable on PubMed and referenced by the NTCID.…”