Seizing opportunities based on pandemic learnings.
There are widespread discussions around the use of disruptive technologies for clinical trials, including broader application of data initially recorded in an electronic format, or eSource. Added to this are the complexities of versatile, convergent technologies used by patients to participate in clinical research, such as smart devices, wearables, and telemedicine.
“As decentralized clinical trial (DCT) elements are increasingly applied, sponsors, investigators, and clinical research professionals all need to understand and apply these technologies for more efficient clinical trials and more convenient patient engagement and participation,” says Nadina Jose, MD, an Assistant Professor in the School of Health Professions at Rutgers, The State University of New Jersey. “The process of selecting the right technology and choosing when and how to leverage it to develop an efficient workflow remains a major challenge. Choices are typically influenced by the degree of urgency, protocol complexity, and business case.”
“One major learning from trials during the pandemic is that efficiency and quality can go hand-in-hand, if the right processes are in place and supported by the right technology,” asserts Jose. “In terms of trial processes, it is essential that patients do not have to wait too long, healthcare providers are not confused by multiple systems, and clinical research professionals are able to make educated assumptions in planning and executing clinical trials.”
In a recent case study described by Jose, DCT technologies were successfully used in a study of the impact of an extract from a flowering plant in the amaryllis family (Crinum latifolium) on lower urinary tract symptoms. Carried out at two sites in Mexico at the height of the COVID-19 pandemic, this observational study involved 46 participants. Patients were able to provide consent electronically, received experimental supplements, and were able to provide feedback through the system’s telemedicine feature. A report on the study concludes, “When patients feel safe and their convenience is factored into the conduct of a clinical study, they are more responsive and compliant with the protocol to complete the study.”
“The on-time successful completion of this study would not have been possible without DCT approaches to ensure patient and study team safety and convenience,” says Jose. “We found that these patients’ experiences with remote study participation were similar to their increased acceptance of telehealth services for their overall healthcare.”
Join Dr. Jose and Avik Pal at ACRP 2023 [April 28 – May 1; Dallas, TX], to gain in-depth insights and tactics on how to streamline the decision-making process through actual cases and toolkits. View complete schedule.
Avik Pal, CEO of CliniOps Inc, echoed this sentiment. “As I wrote recently in Fast Company, a major challenge is to persuade sponsors and contract research organizations (CROs) to seek out clinical research technology providers that are nimble, accessible, cost-effective, and an appropriate fit for hybrid or decentralized trials,” says Pal. “Electronic data collection enables high-quality, rapid data analysis, improving the chances that trials can be completed in a timely manner and making life-saving drugs or devices available to the patients who need them.”
“Sometimes, new and disruptive technologies and platforms are still losing out to siloed thinking and older approaches that biopharma companies and CROs trust, including continuing to send clinical research associates to the site,” says Jose. “It would be better to redirect resources to focus on improved management, process and workflow efficiencies, and true patient care – including gathering data at point of care in as close to real time as possible, and effectively tracking safety signals using improved technologies. In the future, all clinical trial stakeholders should be open to changes and willing to learn about and adopt new technologies.”
Author: Jill Dawson