Study Monitoring Starts with Consent: How to be a Star at Doing Both Remotely
Setting up a clinical trial for a successful conclusion requires a sound, well-designed beginning. Although there are many factors to that equation, it’s impossible to overstate the importance of enrolling—and then retaining—trial participants. One major challenge in this area has historically been the time and travel burden on trial participants to give their consent onsite, and then return several more times for screening and monitoring.
Read on to learn how decentralized clinical trials featuring technology-enabled communications through Telehealth, electronic consent (eConsent), remote patient monitoring, electronic clinical outcomes (eCOA), and more, are empowering researchers to create a more patient-centric clinical trial and transforming the clinical trial experience for patients.
The Patient Journey Begins with Informed Consent
Informed consent, which provides a potential participant with enough information about a study to allow for an informed decision about their participation, is a critical step for enrolling patients in clinical trials. While informed consent form (ICF) signatures have typically been handled on paper at a physical site, eConsent offers an enhanced experience through a technology-enabled digital approach.
The FDA has previously issued guidance on the use of eConsent, which has continued to grow exponentially in response to recent global health events. ICH E6 R3 draft guidance also asks sponsors to consider ‘the potential use of technology to inform participants and obtain informed consent’ further highlighting the growing appetite for eConsent. Electronic consent offers numerous benefits to everyone involved in the clinical trial process, including:
- Receive a more engaging, multimedia experience that guides them through the informed consent process, as well as a reduced travel burden with remote consent.
- Reduces the burden on staff, as many patient questions are answered via the more comprehensible eConsent process and time is saved with the removal of managing paper consent forms.
- Ethics committees/regulatory authorities
- Makes it easier to retrieve source data for inspections, audits, and monitoring in a paperless environment.
- Able to recruit and enroll a more diverse patient population, along with streamlined workflows, enhanced data quality, and compliance, in addition to increased transparency with real-time reporting and insight into study progress.
Patient screening and monitoring
Once informed consent is received, patients must be screened and then monitored throughout the trial. This is yet another area where technology-enabled communications are revolutionizing clinical trials, as remote patient monitoring is now readily available via wearables, direct data capture and telemedicine, freeing patients from the need to travel onsite, and allowing monitors, CROs, and Sponsors to review data virtually.
FDA guidance for conducting clinical trials during COVID-19 restrictions supports remote monitoring for oversight of clinical sites, and much of this guidance will likely continue even after the pandemic. As a result, clinical trials have the potential to become more patient-centric, more inclusive, and more flexible—ultimately reducing the burden on patients and sponsors.
How to be a Star: Consider the Patient!
When setting up a clinical trial, it’s critical to consider who the patients are and why they’re participating. Clinical trial participants are gaining access to new and potentially improved treatment, but they are also altruistically giving up their time and accepting unknown risks in the name of furthering scientific research. Not only do these patients deserve a trial based around their needs, but doing so can also increase patient engagement and retention, allowing for a more successful trial overall.
Here are three ways to make a trial more patient-centric:
- Use a simplified protocol design that’s easy for the patient to understand
- Deploy easy-to-use technology that puts less burden on patients, sites, and sponsors by providing flexibility, modularity, and ease of use
- Provide a hybrid clinical trial—meaning patients have the option to visit a site, or be remote, for all or some of the required visits
The role of remote technologies in patient-centric trials
As COVID-19 swept across the globe, the need for new, patient-centric technologies like remote consent (eConsent) and remote monitoring solutions (Televisits) became extremely urgent. Medable responded to this need by developing an integrated platform that provides the most efficient way to view trial data. For researchers, this means you can now connect your patients to their physician using a single 21 CFR Part 11 compliant solution that’s fully integrated with your clinical studies’ clinical workflows.
Ultimately, this is incredibly good news for patients around the world. Now that digital technologies can capture informed consent and monitor data—then electronically transmit the information to healthcare providers for assessment—it has lowered access barriers, providing more patients with access to potentially lifesaving treatments.
Learn more by contacting Medable today, your ideal clinical trial technology platform partner.