The evolving perspective on the DCT model: Broader application and utility – March 2022

21 November 2022

Welcome to the March Labcorp Drug Development Decentralized Clinical Trial (DCT) blog. This month, we will touch on a few things that all have a common theme: the expansion of DCTs into new therapeutic areas, trial phases and geographies. We will start with a look back at our recent webinar on applying the DCT model to oncology trials, with commentary on the applicability of DCTs to certain types of Phase I trials—a realm where DCT has been slow to take root. Next up will be a case study about the use of mobile clinical services (MCS) in Asia during COVID-19. We’ll close with a video about the breadth of ways MCS can be used in support of DCTs.

On January 11, we held a webinar specific to making oncology trials more accessible to patients. In a panel format, we focused on a series of common questions about the feasibility of incorporating DCT elements in oncology trials and reviewed the evolving perspective that there are indeed many situations where oncology trials benefit from DCT methodologies. In part, the pandemic has helped to “mainstream” some of these ideas, but these adaptations were actually already beginning to be incorporated prior to COVID-19. A key takeaway is that it’s best to start the study design with patient-centric services in mind right from the beginning. In this way, the trial can be optimized to incorporate as many remote elements as are feasible for the clinical indication, rather than shoehorning them in later. The pandemic certainly demonstrated the feasibility of incorporating patient centricity and study continuity from the outset. In the end, an integrative approach to the alignment of study goals, data collection methodology, diversity-focused recruitment strategies and strong delivery can yield a trial that delivers more data, of higher quality, more quickly. Through audience participation, we found that more than two-thirds of the attendees also supported the incorporation of DCT elements into early-phase oncology trials, as long as attention is paid to case-by-case trial needs. Watch the entire webinar here.

We have had a huge interest in providing DCT solutions in the Asia Pacific region, particularly in relation to difficulties in conducting trials during the pandemic. Clients often don’t realize that many DCT services are available in countries within this region. We have recently released a case study detailing one such situation, with a focus on Singapore, where a Phase III trial was at risk due to travel restrictions and stay-at-home orders. In this case, we needed to find an alternative for patients who routinely would go to a hospital for study monitoring services. We were able to provide local mobile clinical staff to visit patients in their homes for the purposes of collecting biological specimens, collecting vital sign information, performing electrocardiograms (ECGs) and supervising questionnaire completion. We were able to keep the study on track thanks to a rapid response to the sponsor’s urgent need; success stories such as this are paving the way for availability of services in an ever-increasing number of countries. Read the whole story here.

Finally, we want to alert you to a new short video that showcases the variety of services that are available through our MCS team. Sponsors often come to us asking about “home nursing” services, but MCS are so much more than that, ranging from navigation and chaperone services, to in-site services as an extension of the investigator team, to central pharmacy management services, in addition to all of the in-home services they provide. We hope you enjoy the video! Click here for MCS Video.