An integrated approach to improve clinical trial efficiency: Linking a clinical trial management system into the Research Integrated Network of Systems.

Low-accruing clinical trials delay translation of research breakthroughs into the clinic, expose participants to risk without providing meaningful clinical insight, increase the cost of therapies, and waste limited resources. By tracking patient accrual, Clinical and Translational Science Awards hubs can identify at-risk studies and provide them the support needed to reach recruitment goals and maintain financial solvency. However, tracking accrual has proved challenging because relevant patient- and protocol-level data often reside in siloed systems.

Drivers of Start-Up Delays in Global Randomized Clinical Trials.

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.