Drivers of Start-Up Delays in Global Randomized Clinical Trials

Lai, Jennifer; Forney, Leila; Brinton, Daniel L.; Simpson, Kit N.

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.