Alcanza Clinical Research

Indeed, this topic has been on our minds at Accel Clinical Services and on my mind personally.

The team and I have been studying what has changed for us in terms of clinical trials, but more importantly, we have been thinking about what that means for the future.

Recently, I was invited to serve as a panelist for the Clinical Trials Transformation Initiative member meeting on this very topic. Here are a few of my thoughts.

We can move much faster using virtual study team visits.

There is tremendous expense with sending study team members to sites for any type of visit. Watching our team carry their laptops around the office pointing the cameras at freezers and door locks for the benefit of the study team on the other side of a Zoom meeting was both entertaining and a clear sign of what is to come. So long as no major negative experience occurs due to this practice, an increase in virtualization of study team visits is likely to be the norm for our industry.

The supply of sites may be inadequate to meet study demands.

Even before the pandemic, there were suspicions about the supply and demand problem in clinical trials, with the number of sites being at least an inadequate mix for the drug development pipeline. This has resulted, in some cases, in specialty studies being placed at general medicine sites, which is not ideal from a clinical or enrollment performance perspective. Seeing COVID-related studies placed at specialty sites such as neurology, oncology, cardiology, etc. is another clear sign that the mix of site capabilities is inadequate to maximize service to the available studies. Sponsors, CROs, and sites must find ways to collaborate to improve the supply of sites to match the demand of studies in the development pipeline.

It is still unclear who should carry the risk of implementing electronic source documents.

I have always found it slightly embarrassing on site tours to point to our rows and rows of paper charts and explain that we still use paper source documentation. This is not due to a lack of desire to switch to eSource or not being able to fit it into the budget.It is that I have always expected eSource, like electronic data capture (EDC), to ultimately come from the study teams at the Sponsor or CRO, with an eventual migration into real-time data entry into the EDC. COVID-19 has highlighted the need for eSource and will likely accelerate its adoption. My prediction is this will come from the study teams and not the sites.

Sites are not prepared for diversity in patient recruitment.

The scientific and social benefit to having diversity among research participants is not new, but the strength of the requirement for individual sites to maintain diversity at specific ratios as seen in COVID vaccine studies is unprecedented. Seemingly, the inability of sites to enroll high numbers of racial minorities has slowed the progress of vaccine studies. It has highlighted two deficiencies among site recruitment capabilities: a lack of depth in research site databases, which do not always collect race as a patient attribute, and the inability to leverage social media marketing to target patients by race. It has also reminded the industry that there are forces at play influencing perceptions of clinical research among some groups and that those forces are not well understood. Clinical research must see more understanding of research perceptions and respond with more education about what clinical research is and is not.

There is a lack of standardization in sharing sensitive information.

In addition to a clear direction on eSource, sites have experienced varying levels of standards and concerns among study teams regarding sharing sensitive information. In some cases, sites have used their eRegulatory system to transmit non-regulatory data. In others, coordinators have held up pieces of paper in front of their web camera for study team review. The common theme is sites and study teams alike have relied on systems that are well-accepted or have some level of compliance certification or assurance. Even so, sites have encountered study team members who will not use screen sharing via videoconference due to security concerns.

We at Accel—and all those of us in the clinical trial field—are always looking for ways to improve the process and continue to push medicine forward. COVID-19 has revealed some interesting truths about ways we need to do that, sooner rather than later.

We look forward to further exploring these areas and continuing to deliver the best care and the best results possible—for the future of treatment.