Optimizing Research Productivity Using Data-Driven Protocol Feasibility

Wendy Tate, PhD, MS, Product Strategy Senior Director, Advarra

As many as 20% to 50% of clinical trials do not accrue participants at the site level, leading to wasted time and financial resources. This waste can be minimized by early selection of trials most likely to succeed. The protocol feasibility review process informs this selection by offering a way to evaluate logistical elements of a clinical trial before the activation process is started.

“No matter how much technology we have, study success comes down to people and processes,” says Wendy Tate, PhD, MS, Product Strategy Senior Director at Advarra. “Decision-making on whether to start or continue a particular study should depend on business-driven reasoning based on data, not emotion. Clinical research is a business that should focus on viable studies.”

Decisions can be supported using data already collected as part of the clinical research enterprise. “We should look at data to determine whether we have the patient population the study requires,” notes Tate. “Doctors often overestimate the number of relevant patients at their institution, so a better way to evaluate this can be by looking at historical data. Another factor is whether a particular physician met enrollment goals in the past, and how recruitment is trending in studies that are underway.”

Financial factors are also important. “We must consider whether we can afford to run a particular study, based on which costs will be reimbursed by the sponsor, what big-budget items are needed, and overall financial feasibility,” states Tate. “Operationally, we have to take account of the equipment and staffing needs for study procedures.”

If the study looks promising based on the available patient population plus financial and operational factors, a stage-gate process can be applied to support go/no-go decisions. This structured approach—where stages refer to steps in the study and gates are decision points—aims to ensure that approved trials receive appropriate resources.

“The decisions from stage-gate analysis are not necessarily just ‘go’ or ‘no-go,’” explains Tate. “Other options may involve delaying study start-up or finishing other studies first. Facilities not available in-house may be supplemented by partner facilities. Financial shortfalls might be filled by institutional funds or a supplemental grant. Decision-making should involve a conversation with the investigator. Topics should include how worthwhile the study is and whether additional resources may be available now or later.”

Data-Driven Protocol Feasibility to Improve Research Productivity

Join Wendy at ACRP 2025 [April 24-27; New Orleans, La.], where she will discuss the stage-gate framework, provide tips on processes that can be used to implement a feasibility process, and offer metrics and data organizations can use to drive the analysis empirically. View complete schedule.

Benchmarks are also applied to decision-making, although these can vary depending on the condition of interest. The bar is typically lowered for rare or pediatric diseases, or for serious conditions with no treatment options.

“Finally, decision makers should know that a new study does not necessarily require a dedicated, formal committee,” concludes Tate. “Early decisions can be handled informally by key people involved in the start-up process. These upfront contributions can help determine whether a study appears generally feasible, and if not, it can be killed quickly to open up space for a project that can be successful.”

Edited by Jill Dawson