Recruiting clinical trial participants, keeping them enrolled and capturing accurate information were growing and expensive challenges even before COVID-19 lockdowns.
Struggling with complex paper forms or hard to navigate websites, many patients were unable to accurately record when and if they took their medications, their reactions to them or their general health status. Even when professionals at a central site perform an EKG or draw a blood sample, they capture only a snapshot of the patient’s condition, not a more complete view of the safety and efficacy of treatment possible through continual monitoring. Such visits, which can cost more than $3,500 each, also cannot record a patient’s experience during an intermittent condition such as a migraine headache or atrial fibrillation.
Traditional clinical trials, which are typically held at physical sites, also are impractical for the nearly seven out of ten patients who live more than two hours from the nearest clinical research site to participate in trials. Further straining the experience, traditional clinical trials require patients to sit through lengthy explanations and complicated legal disclaimers that they often don’t fully understand. Meanwhile, investigators must log onto multiple systems and juggle email threads just to record, assemble, understand and act on patient data. Due to such difficulties, organizations shelved many trials due to a lack of participants.
COVID-related restrictions on travel and personal contact, however, have forced the industry away from traditional trials, accelerating ongoing efforts to use technologies for decentralized clinical trials (DCTs). With a decentralized approach, many tasks can be accomplished remotely by patients themselves or with caregiver support. While this acceleration was born out of necessity, the move to DCTs also represents an opportunity to significantly improve the trial experience, making it easier to recruit, retain and engage the patients without whom it is impossible to complete a drug trial.
Our work with clients has shown that achieving this goal requires improving the experience for patients as well as trial investigators, sponsors and clinical research organizations. Simplifying and humanizing the entire trial ecosystem of interactions, processes and relationships through process reengineering and technology can not only maximize patient involvement but also reduce the cost, risk and delay of delivering new treatments to patients.
To help organizations transform the patient experience by offering decentralized trials, we share a few recommendations.
A frictionless experience for all
Rather than build a trial around an opportunity, for example, to use the latest wearable sensor or mobile app, start by understanding each stakeholder’s goals and how the trial’s routines, requirements and workflow will affect them. Then use these insights to guide approaches, such as how to create trial protocols or what technologies to use to improve the trial experience. Stakeholder experiences to address include:
- Patients, who want to improve, or regain, their health and help contribute to treatments for others. Eliminating barriers to participation requires easy-to-find information about trials that could help their conditions. Once in a trial, they must be treated like people (not “subjects”) and given tools, information and support to minimize their work, worry and discomfort.
- Investigators, who need to conduct trials quickly, while complying with regulations and protocols. They aim to do so at the lowest possible cost while getting the fastest, most accurate information about treatment safety and efficacy. Minimizing paperwork, data entry and technical complexity will help them manage complex clinical trials, giving them more time to develop new treatments and encouraging them to volunteer for future studies.
- Sponsors and clinical research organizations (CROs), who also must complete trials as quickly as possible so they can either bring the treatments to market or refocus efforts on more likely candidates. This requires easy, fast access to real-time trial data and analytics, risk-based monitoring that focuses tracking efforts on the most critical adverse events, and easy, rapid processing of safety cases.
