Preliminary findings from the goBalto 2015 Global Study Startup Survey uncovered significant gaps in the industry’s ability to efficiently manage document workflows and activities associated with starting clinical trials.
The survey found that industry leaders were continuing to adopt “best of breed” cloud-based eClinical solutions, such as clinical trial management systems (CTMS), electronic data capture (EDC) and electronic trial master file (eTMF); however, even the latest releases of those applications fell short in addressing one of the most inefficient and costly bottlenecks of clinical trial conduct: study startup (SSU).
The process of initiating clinical trials continues to remain cumbersome, challenging and often behind schedule, making SSU one of the poorest-performing aspects of clinical trials.
“Excel is still the mainstay in managing clinical trials and while a few have tried to use existing eClinical or document management systems for SSU, they have fallen short,” said goBalto CEO Sujay Jadhav. “Only a purpose-build SSU solution capable of handling complex regulatory/SOP workflows is able to tackle the complexities associated with starting clinical trials, providing true efficiencies via cycle time reductions.”
Unfortunately, the use of Microsoft Excel is still omnipresent. More than two-thirds of sponsors and CROs use Excel for site selection and evaluation, with the majority of sponsors (93%) and CROs (80%) using Excel for site feasibility. Moving further into the clinical study life cycle, activation, over 80% of sponsors and CROs still use Excel for tracking of SSU processes.
Ironically, three of the top sponsor/CRO pain points were directly related to the limitations of using Excel for SSU, namely; lack of operational oversight with no availability of real-time reporting on clinical trial status (or CRO performance); lack of project management standards, particularly activities impacting milestones along the critical path; and lack of integration of systems for site selection, feasibility, activation and document management.
Business intelligence initiatives continue to be top sponsor and CRO priorities, as executives demand greater visibility into trial data at a much faster pace. Manually prepared data often is too old to reliably represent status, and readily proving you’re on track is still an ongoing challenge. Instead of traditional, one-dimensional, static reports, sponsors and CROs desire interactive, real-time answers about study startup statuses.