Study activation seems like a double-edged sword – before opening a new clinical trial, it is important to craft a detailed and thorough budget, negotiate with the sponsor, receive approvals and sign-offs, and determine feasibility of the protocol at your site. But all of these important processes take time, resources, and an upfront investment from your site. More time spent on study activation results in a lower chance of meeting financial and accrual targets. So how do sites balance the need to open a study quickly with their regulatory obligations and financial goals? Is it possible to both streamline study activation and remain operationally viable?
In late 2020, Advarra conducted a survey, asking clinical research site professionals to examine the current state of study activation in the industry and identify the processes and resource constraints impacted. This report (a) illustrates key factors affecting study activation, and (b) provides suggestions and solutions to sites who want to improve their study activation process.
Five notable success factors from sites who have improved study activation are described in more detail in this report:
- Financial viability requires comprehensive budget development and negotiation. Budgets must incorporate all aspects of study conduct, including staff and infrastructure costs.
- Understaffing limits research capacity and puts sites at risk for errors. Staff must be augmented to provide needed resources and expertise.
- Sites must understand each component of study activation in order to identify and implement process improvements. Knowledge of current activation processes is a necessary first step.
- Accrual must be evaluated by past performance and upcoming potential. Ignoring past performance leads to repeated misjudgments.
- Trials fail to meet financial goals on a regular basis, which makes it harder to run an effective and efficient research program. An early feasibility assessment increases the study’s chance for success at the site.