The Momentum of Decentralized Clinical Trials: An Interview with R’Kes Starling

by | Mar 23, 2021 | Blog, McCreadie Group, Research Pharmacy

March 2021 | Jennifer Drabing, Senior Marketing Communications Manager

McCreadie Group is proud to work with Reveles Clinical Services and privileged to sit down with its CEO and founder, R’Kes Starling, to discuss decentralized clinical trials. This blog, the first part of the interview series with R’Kes, focuses on the future of virtual trails, the impact this new model might have on the roles of pharmacists, and the subsequent need for education and training.

Reveles Clinical Services is a clinical research solutions company committed to expanding the population of people who are able to participate in clinical trials by increasing awareness, expanding access, and fostering trust.

An expert in this area, R’Kes led the round table discussion “Up Close & Virtual: How Hybrid/Virtual Trial Design Impacts Pharmacy Services” at McCreadie Group’s first Research Pharmacy Summit in October of 2020. In the session, R’Kes introduced the challenges and opportunities associated with virtual and hybrid trials for an investigational drug service (IDS). We followed up with R’Kes to continue this important, timely conversation. He gladly agreed to an interview, and we are pleased to share it with you.

Q: What is the future of virtual trials?

A: Obviously, in the current environment, while we are in a global pandemic, there are very meaningful considerations of the role decentralized clinical trials, or virtual trials, will play in the future. I think there is a tremendous amount of momentum in our industry towards the adoption of decentralized clinical trials.

I do think we will start to see more trials that will incorporate the different approaches and methodologies of decentralized clinical trials, but I don’t think it’s going to be a full shift toward complete virtual models. I see the industry being more mindful about the central tendency of what decentralized clinical trials really offer, and that is being more patient centric. I believe that it is very difficult to give something, and then take it back. And so, how I think about this is, if you have allowed patients the ability to engage in these decentralized clinical trials, it’s going to be very difficult to revert them back to the traditional method. So, I think that is one really important consideration for our industry.

I think that likely, we will start to see more guidance from the regulatory agencies about decentralized clinical trial approaches, and you’re going to see general education continue around how to properly onboard your technology vendors and how to select vendors. You’re going to see more educating of the industry around the benefits of decentralized clinical trials. I see the need for conversations about nomenclature. The industry isn’t really clear on the nomenclature. You see things like “virtual,” “remote-less,” and “site-less.” Those mean different things to many different people. Just the fact that we’re still inconsistent in our nomenclature will be a great opportunity for us to educate our industry.

Q: How will the role of Pharmacists change to ensure the quality of patient care?

A: I think, not only in research, but if you look at the health continuum, you are going to see that pharmacists will play a very active role, particularly with the vaccines being rolled out, and most obviously, on the commercial side. However, I think the life science, clinical development, and research and development industries can greatly benefit from having more pharmacists involved. And certainly, Reveles will play a very meaningful role in making sure that we are providing opportunities, whether it is apprenticeships or internships, to expose pharmacists to the very promising, rewarding and fulfilling careers in research. And so, if we believe that the industry will continue to adopt decentralized clinical trials, I think pharmacists are uniquely equipped and trained to help counsel patients, help advise on a particular supply chain, and help with logistics and considerations with other providers. I think pharmacists will continue to emerge as a trusted provider, like they have been historically, year after year. But I think now, they will not only be trusted, but they will also be informed and insightful providers who help introduce clinical trials, help educate patients around the benefits surrounding clinical trials, and then more meaningfully, play a critical role in the operation in conducting clinical trials.

Q: What additional training will be needed for investigational pharmacy practitioners?

A: I think the direct to patient model of decentralized clinical trial offering will certainly require more training, more education, and more rigor around the processes and the complexities around managing the supply chain, particularly around the growth of cold chain products, or products that require special handling. So, I think we’re going to have to think about what training is needed to support these changes.

I also think, certainly, there will be a need to be trained about the patient’s home environment. The patient’s home environment now becomes a site of care and not every home can ensure proper data privacy or that some other parameters are in place. I think it’s going to be really important to understand that now the home is an acceptable site of care and to consider all the things that increase the complexity of care at home.

We want to thank R’Kes for the interview and for allowing us to share his insights on the future of virtual trials. We appreciate his support of research pharmacists, and his advice on learning and adapting changes in the industry. In the next blog in this interview series, R’Kes will discuss the complexities and challenges in managing decentralized clinical trials.

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