Jul 08, 2021
A few months ago, the New York Times reported on the rise of virtual studies. The feature focused on how research teams and patients have benefited from decentralized trials – especially given the pandemic and its impact on the ability to run traditional trials. As with many upticks in technology adoption over the past year, the rise of decentralized trials is something that would not have happened as easily in 2019.
The article struck me. Not because of the subject matter – those of us in the industry have been thinking about the decentralized trial format for a while. Instead, I found it rather remarkable that the mainstream media was covering decentralized trials and moving awareness of this trend into the general public domain.
In it, the article quotes Dr. Mustafa Khasraw, a medical oncologist and clinical trial specialist at Duke University, “We’ve discovered we can do things differently and I don’t think we’ll go back to life as we know it.” I agree - we can and should do things differently. Yet, decentralization is just one aspect of moving the industry towards a modern approach to clinical research.
The Times article is an important signal of the dawning of a new era. The pharma industry must answer this call, not only with decentralized trials but with transformative technologies that support new ways of executing clinical studies. Technologies that go beyond the enablement of old ways and break the mould of traditional, unsuited processes.
I’ve written before about how great progress can come from chaos. Technology provides a pathway to radically improve the clinical trial process – and the pandemic has shown just what’s possible. That said, I agree with the article in that “virtual trials are not a panacea.” Practically speaking, there are trials of certain levels of complexity and design that necessitate a centralized approach. To accelerate and improve clinical research, the industry must take a holistic approach to advancing the use of technology in clinical research. We can’t simply expand the network of study participants and stakeholders without providing tools to connect them with the information they need at these new points of care.
Every person in a clinical trial is important. At the heart of the trial is the interaction between a physician and his or her patient. There is a moment when a physician recognizes that the patient in front of them could be eligible for a lifesaving or life-changing clinical study. This moment could take place at a major research center or out in the community, but it is a pivotal moment in the life of that patient and the life of that research study.
Consider that the Center for Information and Study on Clinical Research Participation (CISCRP) found that 71% of people worldwide would be happy to take part in trials, but only a quarter had their doctor or nurse recommend a trial. Why is this?
The Tufts Center for the Study of Drug Development posited that the problem was communication. On the one hand, the study found that almost all physicians (91%) and nearly three quarters of nurses (72%) felt comfortable discussing clinical trials with their patients. But rather perplexingly, less than 0.2% actively referred their patients to studies. Their reasons? The inability to access related trial information, insufficient information and low turnaround time for referring patients.
When we go back to that moment that a physician has with his or her patient, it is there, at that exact moment in time that the physician needs a solution. It is at that moment that the physician needs to consult the clinical trial protocol to determine the person’s eligibility for the study and to begin a conversation about enrollment. It is at future moments just like that one when the physician will need to consult the protocol to make sure that that patient is managed in accordance with the schedule of activities and to an optimal level of safety and compliance with other aspects of the study.
In addition to offering the highest standard of patient care, we have touched on another aspect of physician satisfaction in our blogs, the concept of “one and done.” Many physicians who do take part in trials don’t want to be involved in another one. And who can blame them? Clinical research can be time-consuming and difficult. Technology holds a promise of improving the experience for physicians and engaging a larger number of them in clinical research, whether they are practicing in the community or at major research centers.
In today’s digital world, physicians should have tools that offer the same degree of speed and convenience that they experience elsewhere. It’s hard to believe that the protocol for most trials is kept on a paper document or a PDF file that resides on a portal, accessible only via desktop, in an office somewhere far away from the clinic. This is the core of why 40% of sites under recruit and 80% do not meet recruitment timelines. Make clinical research more convenient and physicians will be inspired to participate. I believe it’s that simple.
I understand the buzz around decentralized trials and I welcome the attention it has brought to the need to modernize the approach to clinical research with technology. I encourage the biopharma industry to seize the momentum toward the adoption of new approaches and focus on the heart of the matter: enabling point of care solutions that empower physicians to engage with their patients in clinical research.