Drivers of Start-Up Delays in Global Randomized Clinical Trials

Abstract

Background Global, randomized clinical trials are extremely complex. Trial start-up is a critical phase and has many opportunities for delay which adversely impact the study timelines and budget. Understanding factors that contribute to delay may help clinical trial managers and other stakeholders to work more efficiently, hastening patient access to potential new therapies. Methods We reviewed the available literature related to start-up of global, Phase III clinical trials and then created a fishbone diagram detailing drivers contributing to start-up delays. The issues identified were used to craft a checklist to assist clinical trial managers in more efficient trial start-up. Results We identified key drivers for start-up delays in the following categories: regulatory, contracts and budgets, insurance, clinical supplies, site identification and selection, site activation, and inefficient processes/pitfalls. Conclusion Initiating global randomized clinical trials is a complex endeavor, and reasons for delay are well documented in the literature. By using a checklist, clinical trial managers may mitigate some delays and get clinical studies initiated as soon as possible.

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 ].…”

Value drivers of development stage biopharma companies

“…Arguably, US Biopharma clusters in San Francisco, Cambridge (US), and San Diego provide start-ups with better access to human, technological, financial, and social capital to foster scientific innovation than their European counterparts in Zurich, Cambridge (UK), and Munich [ 25 ]. Moreover, stricter legal barriers for conducting laboratory research and clinical trials in European countries could ultimately impact Biopharma’s operating costs, and thereby company valuations [ 43 ].…”

Moving Beyond the Momentum: Innovative Approaches to Clinical Trial Implementation

“…Prolonged trial activation times, reduced patient participation, duplication of efforts, and subsequent costs are long-standing barriers associated with the successful conduct of clinical trials. [68][69][70][71] As a consequence of the COVID-19 pandemic, many clinicians were forced to provide temporary innovative solutions to maintain the continuum of care for their patients. We propose expanding these temporary measures into enduring options to dismantle barriers to trial accrual while maintaining data integrity and preserving patient safety.…”