Solving clinical trial delays: innovative solutions

Abstract

Our objective was to provide broad perspective on causes and consequences of clinical trial delays and suggest process-oriented and technology-enabled pragmatic solutions to minimize trial delays, in particular context of doing trials in India. The main challenges for successful completion of clinical trials stem from regulatory and ethics review, investigator selection, site initiations, participant recruitment and retention, monitoring and data management issues. Careful planning, sorting out ownership issues in the initial steps and a partnership based on shared issues among all the stakeholders will help reduce the trial delays. Such a shared vision will enable adherence to regulatory requirements, enhance the quality of trial conduct and ultimately enable improved access to new treatments and its benefits to the Indian population.