Recent trends in clinical studies, including the nearly ubiquitous move to electronic data capture (EDC) systems across CROs/sponsors and electronic medical records (EMR) systems amongst hospital systems/private practices, has provided a fertile environment in which to institute decentralized clinical trials (DCTs). The additional factor of the COVID-19 global pandemic ushered in a need to explore an expansion of those DCTs, in order to continue critical clinical study work, while protecting the safety of patients, clinical study staff, and the medical professionals involved in their care.
DCTs can have many different meanings depending on the end-user and often take shape in a variety of ways based on the sponsor of the study or CRO being utilized. Various strategies and tools can be deployed under the banner of DCTs. These can range from web-based systems, such as eConsents and ePRO, to more complex designs like wearables or even implantables that can transmit data with little to no active patient engagement required. Each of these potential tools comes with varying levels of risk in utilization, much of which can be obviated with careful attention to the local and national regulations of the regions in which the research will be performed. Additionally, the crafting of Informed Consent documents, with an eye to these regulations and importantly, on educating patients as to who will have access to their data and how it will be used, transmitted, and stored, becomes all the more critical to mitigating risk for both patient and sponsors alike. Obtaining guidance from clinical trial experts familiar with those regulations can play an important role in the long-term success of your trial.
Additional areas in which we have seen the deployment of DCTs has been in two of the most crucial building blocks of a successful clinical study program. The first of which is the connection between the CRO/Sponsor and the clinical study site. An increase in the accessibility of the technology platforms has driven the prevalence and acceptance of remote monitoring visits, eTMFs, and electronic source documentation.
These tools can have a dramatic impact on the costs of running a clinical study program, with some increases in costs seen in the acquisition or utilization of such technologies being counterbalanced, or if properly managed, even exceeded by real opportunities for cost-savings driven by decreased travel needs, fewer hours wasted getting to and from study sites, project overhead and streamlined document procurement and retention.
The second, which is the most critical area of connection in a clinical study and the one with the most potential for future growth, is that between the clinical research staff at the site level and the patient who has chosen to participate in the clinical study.
During the pandemic, the utilization of telehealth skyrocketed to an all-time high and though that trend has slightly rescinded to some degree in the post-acute phase of the pandemic, many of those lessons learned and systems implemented for patient care can continue to be utilized or even reframed to suit differing applications. One such reframing comes in the way of expanding access.
The bulk of clinical study work resides within the academic setting, where systems and structures are well established and there is ample infrastructure to support ongoing research efforts. However, the majority of patient visits and interventions, specifically in some specialties (e.g., orthopedics, gastroenterology, etc.) occur outside of these academic settings and sit as largely untapped potential as clinical research settings. The use of DCT tools in these settings can dramatically augment the potential to conduct research in these often-overlooked centers, by overcoming the main barriers against participation by these centers, which principally reside in the costs of establishing and managing the research infrastructure.
At AlvaMed we are experts in conducting clinical research and have a depth of experience and know-how from the sponsor perspective as well as that of the site/surgeon/investigator. For sponsors, we can offer programs that will utilize this decentralized approach to streamline your research project, provide you access to previously untapped clinical sites, and increase your enrollment speed, all while maintaining the highest level of compliance. For clinical sites, we can provide the necessary research infrastructure to integrate into your practice at no cost.
Click here to learn how to partner with AlvaMed or book time with Marc Quartulli, VP of Clinical Affairs at AlvaMed to discuss this novel approach further.
