After a concerted effort by our industry over the last several years, sponsors, clinical research organizations (CROs) and clinical trial suppliers have added “patient centricity” to our vocabulary and study planning.
The shift to not just think about the patient but think as the patient is a critical effort to advance clinical research for and with patients. Patient-focused strategies such as protocol design insights, focus groups, satisfaction surveys, indication-specific content and study results sharing continue to evolve as potential standard approaches in research studies. These strategies enable more patient-centric approaches and are important but are not the only solutions required to be patient centric.
Participants travel to specific research locations (sometimes an hour or more away) at specific times (which often means taking time off of work) to conduct assessments that in many cases can be conducted remotely. In between study visits, it can be challenging for patients to provide clinically relevant information and quickly connect with their sites to complete study activities. 15% to 40% of patients enrolled in clinical studies drop out before they are completed, delaying study timelines and new product launches. These delays can cost $600,000 per day in lost revenue opportunities for a niche drug and as much as $8 million for a blockbuster drug, underscoring the importance of patient retention in clinical trials.
Fortunately, there is an additional way to improve engagement, retention and timelines that has been brought to the forefront as a result of the Covid-19 pandemic. Telehealth virtual visits have been accelerating as an option available for sponsors throughout the global clinical research industry. Rather than requiring participants to go to sites for every check-in or visit, many clinical trial leaders have turned to telehealth, not only to keep operations steady during challenging times but also to adopt and offer an additional patient-centric approach to studies.
Bringing the study visits to patientsThe pandemic gave a new sense of urgency to patient-centric solutions that extended the site into a patient’s home safely. In the midst of the rampant spread of Covid-19 and fears about contracting it, many patients were reluctant to travel to a centralized location and some patients had concerns with home visits. As unemployment numbers increased due to the shutdown, participants (and their loved ones) were also more reluctant to take time off work and travel outside of their community. Yet it was critical that these life-changing, and in some cases life-saving, clinical trials continue.
Advances in telehealth offered an ideal solution. Rather than bringing patients to the clinic, sponsors and CROs could bring the study visits to patients. This approach enabled visits to continue (albeit remotely) to capture as many of the protocol-required assessments as possible without in-person interaction. Throughout the pandemic, our study stakeholders have been creating new habits around virtual meetings, video teleconferencing and conducting activities outside of brick-and-mortar locations.
This does not infer that in-person visits should be eliminated but does establish that patients, sites and sponsors are adopting virtual visits as an option to provide flexible approaches for study activities. This hybrid omni-channel approach that includes a mix of on-site, telehealth, phone, home health and mobile app creates a new level of convenience, flexibility and simplicity for patients, encouraging them to remain with the clinical trial.
Telehealth creates patient-centric benefitsIncorporating the use of telehealth offers many patient-centric benefits that can be used to mitigate dropout rates and help bring clinical trials to close on-time and on-budget:
Reducing travel requirements. Achieving enrollment timelines often requires the recruitment of patients who live an hour or more from the closest research site. As the clinical trial goes on, this time-and-distance factor can become a larger barrier to participation. By only requiring participants to travel every few months or to fewer overall visits, the burden of travel is eased. Those who depend on hourly wages don’t have to lose pay on a regular basis to meet their obligations, allowing studies to be more inclusive in recruitment. Reducing travel requirements enables studies to expand their candidate pools beyond their normal geographic base, improving the speed of recruitment while also testing the drug on a wider population.
Keeping trials top-of-mind. Many patients who agree to participate do so with enthusiasm and the desire to contribute to research. This enthusiasm can wane over the duration of the study due to the effort required to participate. Telehealth can enable more frequent, shorter duration check-ins and unscheduled sessions to support ongoing questions, provide encouragement and remind patients why they are participating.
Enhancing education. As patients contribute to studies, they can be overwhelmed by the sheer volume of information and complexity in clinical trials. Telehealth visits coupled with patient education sections of the study app and alerts/notifications enable patients to receive information in smaller, digestible forms via text, images and video. It also gives patients control of how much information they review at any one time, as well as the flexibility to choose when to consume the information, which further enhances the learning process.
More frequent data review with the patient. With in-person visits only, the data that researchers acquire and review with patients is typically limited to the day of the visit. For example, they may see elevated blood pressure readings, but those readings could be elevated from the stress of the visit itself or worries about family rather than a reaction to the drug. A telehealth approach that includes remote monitoring enables researchers to gather more frequent readings, conduct study activities during the telehealth session and engage patients in their natural environment. This data (including insights and trending derived from the data) can be reviewed with the participant during a brief telehealth visit to ensure education and any study actions can be taken.
Better relationships between researchers and patients. Trust-based relationships can take a long time to build, especially if contact is limited to a visit every month or more. Telehealth enables those visits to be replaced or supplemented by multiple short encounters, helping create a stronger personal relationship that enhances participation and retention.
Here to stayAs we continue to manage through the pandemic and plan for studies post-pandemic, it is clear that telehealth as a patient-centric approach has the ability to become a standard option for studies. By enabling a more hybrid approach to clinical trials with the added flexibility of telehealth, studies can improve patient-centricity, which will ultimately improve recruitment, engagement, and retention.
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