By Wendy Tate, PhD, GStat, Director of Research Operations at Advarra
Site study activation for clinical trials requires a delicate balance of speed and due diligence; sites need to open for enrollment quickly but also verify the site can meet the logistical requirements of the study. To remain financially viable, it is imperative that sites use their limited resources in the most efficient manner. In late 2020 Advarra surveyed 839 clinical research site professionals about the current state of study activation in the industry and identify the processes and resource constraints impacted. The findings of this survey have been reported out in “The State of Clinical Trial Activations at Sites.”
This report identifies ways to streamline study activation and maximize operational efficiency in four key areas: determining financial viability, optimizing non-participant-facing research staffing, shortening activation timelines, and accurately predicting accruals.
These four actions are key factors in determining whether a protocol is feasible to conduct at a specific site.
Financial viability can be secured through successful negotiation of budgets that cover infrastructure, staff, and procedural costs. The Advarra survey found that many sites did not ask for funds to cover costs associated with necessary infrastructure, such as site technologies and start-up activities like budget negotiation and coverage analysis. However, of the sites that did ask, an overwhelming amount (75% or more) received funds to cover some cost. To ensure proper compensation for study-related work, sites must include the time and effort required for study activation activities during sponsor negotiations. Approximately 50% of organizations responding to the survey, particularly academic medical centers, and universities, noted that the number of staff was the most frequently identified pain point for both budget negotiation and MCA processes.
Optimizing staffing and shortening activation timelines
Having too few staff limits your research capacity and puts your site at risk for errors. Sites must understand each component of study activation to identify and implement improvements. To do this effectively, sites must have knowledge of current activation processes and how long each component takes. A specific time goal for each process is also required to demonstrate measurable improvement. While almost all (99%) of respondents reported the overall timeline to complete the study activation process, fewer respondents were able to report the time it took to complete specific sub-processes, such as IRB, IBC, and budget negotiation. Even fewer indicated that there was a goal to meet for these processes. Without data measuring the overall study activation time and the current time for each sub-process, it is difficult or impossible for sites to implement changes to reduce the time it takes to activate a study in a compliant and financially feasible manner.
Accurately predicting accruals
Sites must be able to accurately predict accrual for a potential study as one component of overall protocol feasibility. When estimating accrual, it is important to evaluate the patient population but also review how previous studies performed. Prior performance is a strong indicator of how a similar study will perform, unless corrective actions are taken to improve timelines, enrollment, or financial viability. While the majority of survey respondents (92%) stated that the pool of potential participants is evaluated during study activation, almost one-third (32%) did not look at past study success/failure to determine if accrual goals were actually met. Past performance can identify successful recruitment strategies, illuminate screen failure rates, and estimate staff and investigator effort required to meet enrollment goals. This analysis maximizes the chance that future studies will meet contracted enrollment goals.
The current reality is that trials fail to meet financial and accrual goals on a regular basis. This makes it hard to run an effective and efficient research program. Completing a thorough feasibility assessment early during the activation process minimizes time and resources spent on studies that ultimately fail to meet their targets. If the study is likely to succeed at your site, an early feasibility assessment can also identify potential challenges and corrective actions — such as resource allocation or outsourcing — that will maximize your chance for success.
Advarra advances clinical research by making it safer, smarter, and faster. For more insights illustrating the key factors affecting study activation, and suggestions and solutions to improve the study activation process, download “The State of Clinical Trial Activation at Sites” report. To learn more about how protocol and site-level characteristics can be used to create models that predict accrual, download Advarra’s white paper: Case Studies in Accrual Prediction.