Clinical trials are essential for the creation of novel treatments for uncommon diseases, but they present several difficulties. To begin with, traditional clinical trial models often require several onsite visits, which can be quite taxing for patients, especially those with uncommon disorders and those who care for them. The Covid-19 epidemic has made conventional clinical trial procedures even more challenging. However, hybrid and decentralized clinical trials, which make use of telemedicine and other digital health resources, have proved successful in maintaining efficient and safe research operations.
In decentralized clinical trials (DCTs), a variety of digital health technologies, including wearables, electronic medical records, mobile health applications, and telemedicine serve to observe and evaluate the participants remotely. This approach reduces the workload significantly for clinical research workers, caregivers, and patients. In particular, a hybrid trial model combines the advantages of digital health technologies and techniques such as mobile healthcare to benefit both the participants and the researchers.
Specifically, with the hybrid clinical trial approach, patients no longer need to travel to the research locations since telemedicine enables virtual contact with healthcare professionals. This flexibility is especially beneficial for patients with uncommon disorders. Moreover, telemedicine facilitates the investigator-monitoring that is crucial for the integrity of clinical trials.
Because of the advantages that the DCT and hybrid approaches offer, they are expected to be adopted over the long term on a widespread basis. And, when the cost of participation decreases, there are more opportunities to increase enrollment, compliance, and patient retention. These conditions are critical for clinical studies of uncommon illnesses since the patient pool is, by definition, limited. The hybrid model, by providing techniques that cater to patients’ individual needs, may also encourage patient-centricity in clinical research.
In some circumstances, though—including early-phase studies with limited safety data—the applicability of DCTs can be limited. Clearly, adequate processes must be in place to recognize, evaluate, and address adverse events. Overall, the experiences and viewpoints reported by the Clinical Trials Office at the Department of Genetics and Genomic Sciences have shown the hybrid DCT model to be valuable in terms of broadening initiatives and, again, supporting patient-centricity in clinical research.
How Organizations Can Adapt to Change
Organizational change requires a tailored approach to decentralization for the sponsors of clinical trials, with some opting for experimental use cases to test technologies and others modifying their operating models and technology platforms to deliver virtualization quickly. Going forward, successful decentralization depends on the ability of leaders to communicate their strategic aims to patients, physicians, and sponsors so as to enhance decentralization across organizations, integrate new processes and systems to support their research and patient care agendas, and highlight successful decentralized trials across organizations. These hallmarks of success remain critical irrespective of variation in the scale and pace of decentralization across the sponsors of clinical trials
