Tools and Strategies to Address Underperforming Studies at Your Institution

Ryan Monte
Senior Product Marketing Manager, Forte
October 8th, 2019

If you follow our educational resources, you likely know we recently wrapped up another fantastic Onsemble Conference, with around 200 Forte customers gathering to learn from industry leaders, share best practices with colleagues and move clinical research forward.

This was my ninth Onsemble Conference, and while each one provides a wealth of new sessions and presenters, there are some topics consistently remaining top-of-mind for clinical research professionals. One of those is the impact of low- or non-accruing studies and how to address them (or ideally prevent them altogether) at your institution. The 2019 Fall Onsemble featured several sessions on this topic. These included the University of Florida’s Katie Eddleton presenting her session Strategic Approaches to Identify Recruitment Issues and Interventions, Forte’s Wendy Tate sharing insights on accrual prediction through machine learning and more.

Below are a few tips from those presentations and previous Onsemble Conference sessions focusing on low- and non-accruing trials.

Create Processes for Communication and Trial Evaluation

One of the most difficult aspects of a low- or non-accruing trial is the conversation with the principal investigator (PI). Because investigators have such an enormous stake in the success of their trials, and because there is often a power imbalance between the PI and the research operations team, these conversations are challenging.

Onsemble Community members have shared that, in order to make these conversations easier, it’s important to have a consistent, transparent line of communication between the PI and research operations teams. Not only will this foster a relationship and build trust, it provides a channel to identify and address problem protocols earlier in the timeline. A PI will never be happy to hear his or her trial is in danger of being closed, but a clear understanding of the institutional policies driving these decisions (e.g. a study is closed if zero accrual after first 6 months), as well as real-time view into the status of their trial, can help avoid the PI feeling blindsided by the discussion.

Another benefit of these discussions is the ability to communicate the value of the research operations team. Your team likely provides guidance and services related to feasibility, budgeting, protocol development, compliance and more. You also likely provide services and payment processes, improving the overall experience for participants. Ensuring your team has the messaging and materials to communicate this to your PIs helps frame your team as a partner in the success of trials, and less as an adversary. It will also help establish you as the operational experts, while not threatening the PI’s position as the clinical expert.

Quantify the Impact of a Non-accruing Study

At Onsemble, another key question is how institutions quantify the financial impact of a non-enrolling study. In her presentation at the 2019 Fall Conference, Beth Kettenring, Director, Office of Sponsored Programs​ at Ochsner Health System, shared a years-long analysis on the cost of non-enrolling trials.

While her session was focused on non-accruing industry trials (not IITs), much of the cost and effort remains the same. She found non-accruing trials cost the organization almost $1.8 million over a five-year span.

Based on this data, Kettenring made several recommendations to offset the costs of these trials. First, she recommends that centers review startup fees on an annual basis to make sure these costs are recovered. Next, she suggests creating a feasibility review committee to analyze new trials, as well as a protocol review and monitoring committee (PRMC) to evaluate ongoing feasibility.​ And last, Kettenring suggests centers develop an assessment tool to evaluate workload capacity for CRCs, ensuring successful studies are properly staffed while avoiding low-accruing trials.

Utilize Analytics to Identify and Avoid Underperforming Studies

Recently, new technological and statistical advancements have enabled research operations teams to more accurately and effectively evaluate protocols. Tools like Forte Insights helps identify at-risk studies, allowing PIs to get an up-to-the-minute look at the performance of their protocols. Many centers have done their own research into how they can better conduct protocol feasibility prior to taking on new studies. For example, a group analyzing UT Health Cancer Center San Antonio trials over a 16-year span was able to develop a model to predict low-accruing trials based on factors such as sponsor type, trial phase, disease category, type of trial and disease state.

In her recent Onsemble presentation, Wendy Tate, Director of Data Analytics at Forte, presented a summary of her work utilizing machine learning to develop an accrual prediction algorithm. She shared how data-driven decisions can assist in determining whether a protocol is feasibility to conduct​, how Forte is partnering with the customer community to test this concept in practice​, and what types of metrics, performance data and methods can be used to maximize the feasibility review process at an organization.

To learn more about how Forte can help your organization identify your “problem” protocols, evaluate your program performance over time and use actionable data to improve your operational decision, reach out to schedule a Forte Insights demo for your team.