Sites and Sponsors: How to Split the Risk and Reduce Screen Failures
Clinical trial screen failures happen when potential participants consent to join a trial but are subsequently determined to be ineligible in the screening process or decide to withdraw consent. As this process is costly and time-consuming for sites and sponsors, both stakeholders are highly motivated to mitigate screen failure rates to reduce the overall risk for the clinical trial. This article explores ways stakeholders can work together to reduce the risk of screen failures and increase clinical trial success.
Screen failure costs to sponsors and sites
Although it’s widely understood that screen failures and non-enrollment are costly to sponsors and sites, actual rates are generally not published and can differ widely by therapeutic area. For example, one review of clinical trials for genitourinary cancer placed the mean screen failure rate at approximately 20 to 30 percent, while some studies for Alzheimer’s have posted screen failure rates of 70 to 80 percent.
For both sites and sponsors, enrolling an adequate number of participants can prove extremely challenging. Researchers estimate that 40% of sites in a multi-center study will under-enroll despite doubling the enrollment period, and up to 10% of sites will fail to enroll a single patient. Screen failures are one of the key factors contributing to challenges in enrollment that sites face.
In addition, financial arrangements between sponsor and sites often use screen failures as a success metric, making it even more critical to refine the recruitment process.
Reducing screen failure risk
Ensuring an optimal patient recruitment process is the best way to reduce screen failures, with sponsors and sites having separate but complementary roles to play.
- Ensure that protocol design is both patient-centric and feasible: When creating the inclusion and exclusion criteria, carefully consider the criteria to avoid being overly restrictive and creating downstream difficulties with enrollment.
- Collaborate to reach your audience with the right message: By partnering with patient recruitment companies, connecting with patient advocates, and deploying digital advertising, you’ll be better equipped to recruit suitable participants.
- Use every tool you can: Leverage recruitment and enrollment strategies with demonstrated success reaching the desired participants based on historical enrollment metrics, local community needs, health and medical trends, and multi-media effectiveness.
- Track and analyze: Capture screening information on screening logs and conduct analysis to inform future recruitment efforts.
Joint efforts between sponsors and sites
A macro shift in the industry toward new technologies has created even more opportunities to lower the risk of screening failures. Highly flexible and patient-centric decentralized clinical trial (DCT) technologies now exist, such as digital patient screening and eConsent, that can help pre-identify patients even earlier in the process.
Through digital patient screening that doesn’t require potential participants to travel onsite, the burden on patients is reduced. This may allow you to expand your reach geographically and find more eligible patients through the screening process, ultimately increasing chances for enrollment success.
By utilizing patient-centric, engaging technologies, such as eConsent, to educate the patient throughout the consenting process, you can mitigate the potential for confusion and frustration often associated with pencil-and-paper screenings that patients feel intimidated and overwhelmed by. When patients truly understand the protocols and what’s required of them, they’re less inclined to withdraw their consent later on.
Medable has created a flexible, modular, and extensible decentralized clinical trial (DCT) platform that provides a number of benefits:
- Patient screening from any device, including Bring Your Own Device (BYOD) or provisioned
- Decreased deployment time, with more choice for patients
- Collection of a range of screening assessments across multiple TAs
- The creation of protocol-fit patient workflows.
Ready to get started? Contact Medable for a demo today.