Screen failures—potential participants who go through the screening process but do not enroll—are costly to both sites & sponsors, but a better approach to eConsent can help reduce the risk of screen failures & increase overall clinical trial success.
Screen failures and non-enrollment cost time and money
Sponsors and sites have a certain cost responsibility per participant, representing the time and resources required, and therefore screen failure rates are a key success metric. But high screen failure rates plague the industry: multiple studies have found screen failure rates averaging between 20 and 30%, creating financial loss as no usable data can be collected from the unenrolled participant. In fact, screen failures are estimated to cost the study approximately $2000 per unenrolled subject.
In addition to the resource burden created by screen failures, there are ethical and regulatory considerations necessary to stay ahead of the evolving landscape of FDA and other entities. For example, current FDA standards for screenings and patient consent include a visit with a medical professional to discuss consent and gather screening data. This is potentially a costly and time-consuming process for both the patient and investigator, emphasizing the importance of leveraging technology (like digital patient screening and eConsent) to help reduce burden and cost while increasing patient access and, ultimately, improving the enrollment process.
Optimizing patient recruitment
Reduction of screen failures benefits both sponsors and sites. Optimizing clinical trial recruitment is of high priority during trial development and the patient recruitment period.
Sponsors must ensure the protocol design is patient-centric and feasible—for example, ensuring the inclusion and exclusion criteria are reasonable for the patient population available at the site. Sponsors should also engage patient recruitment companies, connect with patient advocates, and deploy digital advertising techniques to help reach recruitment goals on time.
Clinical trial sites may also play a role in reducing screen failures by using a variety of outreach methods and patient recruitment strategies from the beginning of the recruitment period. This includes keeping the process simple and easily accessible on available digital platforms and using a unified enrollment system to ensure consistent eConsent review across all sites. All direction, design, and data capture also needs to be clear and easy to understand for potential participants. Finally, sites can capture screening information on screening logs and analyze this data to help inform future recruitment efforts about the effectiveness of their techniques.
The Right Approach to eConsent
Decentralized clinical trial (DCT) technology, such as eConsent with embedded videos and learning checks, allows for more thorough patient education to help ensure participants understand what is involved in the trial. When participants are better aware of what their participation involves, this greater understanding can lead to a reduction in screen failures, reducing cost for both sponsors and sites. Patient-facing technologies like eConsent can also help by focusing on patients who meet eligibility criteria earlier, by allowing patients within a greater geographic area to be considered, and by contributing to faster overall enrollment. An NIH study found the use of eConsent resulted in improved comprehension and participation, and also revealed a participant preference for eConsent over other delivery options. A 2018 study of HIV patients found eConsent facilitated usability and informed decision-making for participants.
Digital patient screening can also be used to collect data more easily and pivot quickly in the process. Additionally, this lets study staff include a wider geographic area and bring more patients into the screening process, increasing chances for enrollment success.
Why Choose Medable
The multimodal flexibility of Medable’s digital patient screening and eConsent allows patient screenings and consent to take place anywhere, on any device (BYOD or provisioned), which speeds the screening process and identifies eligible patients more quickly. Our platform decreases trial deployment time while providing patients with more choice. DCT and digital screenings make it possible to collect a wide range of screening assessments to help create protocol-fit patient workflows.