Patient recruitment and retention are some of the most significant challenges to the successful completion of a clinical trial. As many as 80% of all clinical trials experience delays, the vast majority due to recruitment challenges. Beyond initial recruitment struggles, it can also be a challenge to retain patients: as many as 20-30% of patients who elect to participate in a clinical trial will ultimately drop out due to the burden of participation, including frequent visits, invasive procedures and complex protocols.
Despite widespread awareness of these issues, and corresponding commitments by clinical trial sponsors to patient-centricity in clinical trial design, it continues to be a challenge to find and take concrete steps to mitigate patient burden.
At Faro, we believe one of the biggest hurdles to reducing patient burden is being able to quantify it. Using Faro’s Study Designer, clinical development teams can get real-time insights into the impact of their specific protocol on patient burden during the protocol planning process itself.
How it Works
Faro Health’s Study Designer empowers clinical development teams with data and tools to optimize studies more easily than ever. The power to quantify, and reduce, patient burden lies in Faro’s digital schedule of activities (SoA) and richly detailed biomedical concept library.
For each assessment or measurement the study requires the patient to undergo, Faro maintains associated industry standard estimates of time, cost, and blood volume for the patient, in addition to capturing estimates of time, cost, and schedule complexity from the perspective of other stakeholders such as sites and sponsors.
As clinical teams design the protocol, they can quickly and easily evaluate the sources of patient burden, and determine whether or not there are ways to mitigate the burden while still meeting study objectives and regulatory requirements.
Insights in Action
In early 2024, Faro partnered with study teams at Merck to leverage Faro’s Study Designer to measure trial complexity, including patient burden, across trials in six therapeutic areas. The teams ultimately found over 160,000 in potential patient-hours that could be saved, and $130 million in potential cost reductions, by making specific changes to the protocols. Ultimately, they adopted changes that saved over $65 million and over 72,000 hours of patients’ collective time, which would not have been possible without a way to quantify the complexity of these studies.
To learn more about how Faro’s Study Designer could help your organization reduce patient burden in clinical trials, please contact us!