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.
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:
We envision a decentralized clinical trial environment in which:
As clinical trial stakeholders cope with pandemic-driven shutdowns, they must work together to use technology to make clinical trials more efficient, less expensive and more sensitive to the needs of everyone involved. Collaborating from the start of the trial design, sponsors and CROs should include the use of digital tools in their plans to help prevent delays and eliminate the costly need for additional approval for the use of such technology once the trial has begun.
For one of the largest global biotech companies, we enabled more than 30 DCTs across 10 therapeutic areas across the globe, enabling remote capture of patient data and questionnaire responses using telemedicine and remote monitoring. We also configured more than 20 electronic clinical outcome assessment platforms and revised the management of data generated to make it easier for patients to create, and investigators to access, information about patients’ responses to treatment.
For a recent oncology treatment trial, we deployed wearable devices to continuously monitor patients’ biomarkers, eliminating the need for frequent trips by elderly patients and their caregivers to a central site for blood draws.
We are already seeing pharmaceutical developers and service providers partnering to build common approaches and platforms, such as our own Shared Investigator Platform in which multiple pharmaceutical companies allow administrators to share common processes and documents through a single sign-on, reducing risk while increasing efficiency.
In addition, more than 75 life sciences, IT and regulatory organizations are working together in the Decentralized Trials and Research Alliance, of which Cognizant is a founding member, to speed the adoption of patient-centric decentralized trials.
Our understanding of what is required for true patient-centric DCTs is evolving rapidly, as are the emerging technologies, processes and platforms to enable this model. As patients worldwide seek new treatments in greater volumes — and more quickly than ever — now is the time to make clinical trials so convenient for every stakeholder that the resulting experience will maximize patient participation.