It Takes a Village to Humanize the Clinical Trial Experience
Enabling patient-centric clinical trials requires easing the experience for not only participants, but also for investigators, researchers and sponsors to ensure that trials attract and keep patients engaged.
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.
A better trial experience for all
We envision a decentralized clinical trial environment in which:
A patient’s electronic medical record automatically triggers notifications about relevant clinical trials, while consumer-grade patient support programs — including portals, help desks and links to other participants on social media — provide access to real-time expertise and information to serve them and their caregivers.
Rather than using long, jargon-filled consent forms and protocols, patients are onboarded and trained with immersive, gamified content that rewards them for taking their treatment and recording their reaction to it. Easy to use wearables and empathetic, personalized attention makes it worthwhile and even pleasant for them to stay in the study.
Smart medication dispensers automatically track whether and when patients took their medication, while wearable sensors automatically record and transmit their reactions to it. This saves the patient effort and provides more accurate, timely information to investigators and sponsors. Such increased adherence to trial protocols allows smaller sample sizes, which further reduces the burden on organizers and sponsors.
An evolving set of digital tools makes it easier for patients to participate in trials without visiting a physical site. This allows even disadvantaged, distant or immobile patients to participate in trials, assuring equitable access to care and broadening the trial base for the most complete assessment of treatment efficacy and safety. It also, however, requires individualized support and remote tools.
At-home sample collection, such as dry blood collection using paper sample strips, eliminates the need for expensive visits to a patient’s home to draw blood and shipping frozen blood for testing. A global pharmaceutical firm estimated that such dry blood collection could be used to test up to more than 90% of its compounds in development. It would also save a reported $1.5 million, per trial, in the cost of dry ice used to freeze samples, and contribute to other labor and equipment cost reductions.
Centralized collaboration tools, electronic document interchange, digital payments and video conferencing make it easier for investigators to coordinate trials and enter case information. Sponsors can deliver critical information such as safety notifications more quickly and assuredly than with current paper-based mechanisms.
With less paperwork, data entry and manual coordination, investigators can spend more time improving treatments, and healthcare providers can spend more time helping patients and their caregivers to navigate the trial process.
Faster, easier access to real-time clinical and operational analytics, risk-based monitoring and safety-case processing reduces the time, cost and risk of bringing new treatments to market.
DCTs in action
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.