Factors influencing the time to ethics and governance approvals for clinical trials

Abstract Background Clinical trials are at the heart of medical research, enabling the development and implementation of new treatments. The time it takes to commence clinical trials at sites can be long, and ethics and governance approvals are key steps on the pathway to site activation. Methods This paper explores factors influencing the times to ethics approval, governance approval and site activation. Broadly, these comprised trial characteristics (disease area and trial phase), site characteristics (public or private ownership, country) and characteristics of the ethics and governance processes (scope guidelines, mutual acceptance requirements and triage of projects by risk). Median times were compared between site initiations that were and were not exposed to each characteristic using non-parametric tests in univariable and multivariable regressions. Results There were data from 150 site activations done across 91sites, 16 trials and 5 countries. The overall median time to activation was 234 days (range 74 to 657), with ethics approval taking a median of 48 days (0 to 369) and governance approval a median of 34 days (0 to 489). Both the univariable and multivariable analyses identified associations of disease area, particularly oncology (p univariable = 0.012, p multivariable = 0.044), use of scope guidelines (p < 0.001, p = 0.020) and use of a triage process (p < 0.001, 0.043) with shorter median times for governance approval. These characteristics (all p < 0.001) plus early trial phase (p = 0.028) were also predictive of shorter median times for ethics approval in univariable analyses, but none remained predictive in multivariable models (all p > 0.054). The only factors associated with reduced overall time to site activation in both univariable and multivariable analyses were early trial phase (p < 0.001, p = 0.013) and mutual acceptance of ethics approvals (p = 0.031, p = 0.030). Interpretation Times to ethics and governance approvals were only one third of total trial start-up time. Factors influencing times to approval and activation were somewhat inconsistent across analyses, but it seems likely that the introduction of selected governance and ethics processes can reduce approval times.