Digital clinical trials are dramatically boosting patient enrollment — now it’s time for sponsors and CROs to focus on retention.
With the potential to reduce costs for sponsors and increase convenience for patients, digital clinical trials have become a popular topic for researchers. Mobile technology has opened new doors in terms of recruitment, enabling patients to begin the enrollment process on their smartphones. However, despite their added convenience, digital clinical trials are experiencing exceedingly high rates of attrition — patients are dropping out of studies or simply not following through with participation requirements.
For instance, the Apple ResearchKit — which allows patients to take surveys and enroll in clinical trials on their phones — has helped recruit hundreds of thousands of patients, but only managed to retain a fraction of them. In fact, 90% of enrolled patients stop interacting with the app within three months.
Attrition is a real challenge for sponsors and CROs, but digital trials are continuously making strides when it comes to patient engagement. Digital technology has the potential to create connections with patients over new and unique channels, including automated emails, text messages, and social media groups. With a carefully executed strategy, clinical trials can take advantage of the benefits of these new approaches without being hamstrung by excessive attrition.
Potential for Digital Clinical Trials
Focusing on one trial in particular — the recent Apple Heart Study — is instructive in understanding why patients are dropping out of medical research. This study enrolled nearly 420,000 patients who were free from atrial fibrillation (AF) and atrial flutter at baseline. The researchers used a mobile app to measure heart rate and detect irregular blood flow. The app notified patients if they experienced warning signs of AF, and then prompted them to contact a telehealth physician. Depending on the results of their video consultation, at-risk patients were instructed to wear an ECG monitoring patch for seven days.
Of the 420,000 patients who enrolled in the study, 2,161 received an irregular pulse notification. Of these patients, 945 (44%) attended their subsequent telehealth consultation. An ECG patch was mailed to 658 patients, 450 (68%) of whom returned it for analysis. This means that just 20% of those who received an initial atrial fibrillation alert from their device followed through to the final step of the trial.
The Apple Heart Study saw higher than anticipated drop-off rates, but despite these setbacks, hope is not lost for digital trials. By lowering costs, increasing efficiency, and streamlining enrollment, telemedicine has the potential to revolutionize clinical research. Though sponsors and CROs are still experimenting with the most effective ways to conduct digital trials, technologies like wearables and mHealth apps are unlikely to go away. By taking a patient-focused approach, clinical trials can use digital technology to reach wider audiences and accelerate publishing timelines.
Keeping Patients Engaged
Digital technology makes consistent communication with patients simple and easy. Marketing management systems can be used to send patients regular automated emails or convenient reminders via SMS. Sponsors can also use multimedia content like videos of patient experiences to keep participants motivated and engaged.
Further, sponsors and CROs should invest in creating patient-centric websites or landing pages. Clinical trials can be highly technical and difficult to understand, but a dedicated microsite or landing page can help make the information more accessible. Patient-centric content like FAQs, personal stories, and suggested questions to ask doctors can improve participation by making the process less intimidating. The National Institutes of Health, for example, have created a clear and friendly section of their website dedicated to the patient experience.
Sponsors and CROs may also want to keep patients engaged by creating and moderating groups on social media. These groups can be public or private, and allow patients to ask questions and share experiences. Trials can use this forum to share relevant information and updates as well. Public groups can even be used as a way to recruit potential patients who may be interested in learning more about a trial before deciding to participate themselves.
Though a number of digital trials have made strategic missteps, their potential to advance patient care and improve research efficiency cannot be denied. By continuing to experiment with trial design and keeping patients engaged through digital technology, sponsors and CROs can build a sustainable solution to recruitment and retention challenges.