By Rajesh Jain, MBBS, PharmaLex
The upheaval wrought by the COVID-19 pandemic has had a silver lining for researchers and participants in decentralized clinical trials (DCTs), giving rise to a transformational philosophy more attuned to the needs of the patient.
Although digitalization has important roles across the pharmaceutical industry, in R&D innovation, for example, and DCTs have been an option for more than a decade, the pandemic has been the catalyst for change. It has influenced how trials are conducted, establishing a truly patient-focused approach, improving trial outcomes, and delivering efficiencies.
Patient recruitment and retention for clinical trials have long been problematic. Patients drop out because they don’t feel connected and the demands on their time to visit research sites can be overwhelming. The evolution of DCTs allows participation from the comfort of home. COVID-19 has shown that virtual trials are not only possible but effective. With patients in home quarantine, entire studies were done remotely, with information collected using mobile apps.
There are two main components enabling DCTs:
- An enriched ecosystem: Connectivity and networking make the process more attainable and straightforward for patients. Technology platforms connect patients, clinicians, site investigators, sponsors, regulators, and other stakeholders in the clinical trial ecosystem – the essence of decentralization.
- An expanded reach: Data-sharing in real time makes processes more efficient and cost-effective, even expanding the scope of trials to more patients across wider areas and speeding up research.1 DCTs require a willingness to adopt new digital technologies as well as a mindset change, including being open to new procedures, approaches, and innovations.
Connecting, Collecting: The Solutions
Digital trial solutions fall into three broad categories:
- Patient-facing platforms, which are key in improving patient centricity. At trial enrollment, e-consent makes it easier than traditional paper methods for patients to get information about the trial, its ethical and social issues, and the potential user experience. Studies have found that well-designed e-consent – using interactive components, questionnaires, patient-specific information, and graphics – gives clinical trial participants a better understanding of the information.1 Patient engagement apps keep the patient connected, modify their behavior toward the study team in real time, and provide regular reminders about their responsibilities, such as taking medication or completing a questionnaire. The patient can connect to caregivers using chat messages or video conferencing calls.
- Data collection modules come in many forms, such as eSource, wearables, devices, and electronic health records. They allow study staff to capture clinical trial data in real time. The final part of the puzzle is telemedicine, connecting patients and clinicians and supporting their healthcare needs.
- Data exchange. Through use of real-world data from community-based healthcare practice and by tapping into an expanded healthcare network, there are opportunities to enhance patient identification and enrollment – a particularly useful capability when it comes to rare diseases – and devise innovative clinical trial designs.
Besides the technology component, change management is an important aspect of DCTs for all stakeholders – sponsors, investigators, and regulators, who are forced to alter their clinical trial methodologies to adapt.
Traditional clinical trials have depended on manual processes such as on-site patient visits for data collection, monitoring, and verification. In a DCT, because data is available in near real time, review and analytics can be done remotely. The focus is on source data reviews, risk assessment, and adapting what’s being seen in the trial. There is also greater focus on medical monitoring and data sciences. A centralized investigator team can interact with the patients’ primary caregivers.
The transformation also requires investment, though given the millions of dollars companies lose each day because of trials not meeting deadlines, the savings from DCTs can be significant. According to Tufts Center for the Study of Drug Development, DCTs offer the potential for 14 times the return on investment for Phase 3 trials through faster trial timelines.2
Digital enablement, data security, and data authenticity are key to DCTs and can be resolved with the right technology and processes. A digital technology can qualify for use in a DCT only if the required principles of anonymization are in place. Sponsors must ensure that the system keeps data anonymous while the institutional review boards (IRBs) need to be vigilant about ethical standards.
Protocol design will influence trial applications with ethics committees or IRBs as well as regulatory submission activities. This might explain why sponsors are reluctant to embrace a fully decentralized or digitalized process. If wearables are central to data collection, sponsors need to be assured that the health authorities will accept that data and that the process meets ethics committee standards. As researchers and sponsors become more at ease with DCT technologies, clearer guidelines and improved safeguards for data exchange will follow.
Technology continues to evolve, and patients and clinicians are increasingly comfortable adopting digital technologies to support their healthcare and to engage in clinical trials. Nevertheless, while some studies, such as those investigating COVID-19 treatments, have been fully digitalized, most still use only some components of digitalization.
It may be a few more years before DCTs are the norm, but as sponsors, clinical research organizations, investigators, and patients are more exposed to them the acceptance should grow. It is likely there will always be a need for patients to visit clinics or health centers for face-to-face interactions, but there is no doubt that DCTs and digitalization are starting to transform clinical research.
- Empowering clinical research in a decentralized world, De Brouwer, W., et al, Nature, July 2021, https://www.nature.com/articles/s41746-021-00473-w
- Analysis: DCTs Are Proving Their Benefits, Significantly Cutting Down Trial Costs, Jan 2022, https://www.centerwatch.com/articles/25930-analysis-dcts-are-proving-their-benefits-significantly-cutting-down-trial-costs
About The Author:
Rajesh Jain, MBBS, is head of operations India and global lead clinical development solutions at PharmaLex. He has spent many years in the pharmaceutical industry, working in global clinical trial management as well as in medical affairs and leading business operations. He is focused on bridging medical science and clinical operations with digital technologies for improved efficiencies and outcomes. Jain received his Bachelor of Medicine, Bachelor of Surgery from Grant Medical College Mumbai.