The COVID-19 pandemic disrupted clinical trials, forcing many sponsor companies to either halt trials temporarily, shift to virtual or hybrid trials, or just lean more strongly on remote study management. As restrictions on in-person hospital visits were lifted and clinical trials resumed, technology companies were there to help upgrade our industry's tools and modernize clinical trial models.
As clinical trial modernization continues, it is important to keep the patient at the center of the equation emphasizing the human side of clinical trials. Site-based trials will remain a significant part of the clinical research paradigm. While technology will push trials ahead, in-person interactions and site relationships are and always will be, the key to success in delivering patient-centric trials on time.
BioPharma Dive's studioID recently spoke with Brenda Reese, Head of North American business development at PSI CRO, a full-service, privately owned global CRO, about technological adoption in clinical trials, the human connection, and what is needed to be successful at finding the balance between the two.
What particular technology trends do you see being emphasized during and after COVID-19 (for example, digital endpoints, telemedicine, wearables, virtual trials, data integration/AI)?
At the beginning of pandemic, technology companies were quick to come forward with a host of solutions and tools to maintain access to both routine care and clinical trials. Platforms to allow remote monitoring and decentralized trials were immediate answers to ensure patients could still access their providers. Most notably, telemedicine has seen a drastic increase through the adoption of Zoom and other tools to facilitate virtual visits. We anticipate that many of these tools will catch on for good. By providing virtual options, connecting with a doctor has become even more convenient for patients. Instead of a commute, or waiting in a lobby, patients can log in from their homes, their offices, or anywhere in the world to discuss treatment options with their doctor. That's pretty amazing.
Are these trends set to take the place of in-person visits and/or in-person processes?
Many of these trends will certainly last beyond the pandemic, and many might even take the place of in-person visits in specific therapeutic areas or indications. But the switch to technology should be patient-centric first and foremost. While some patient populations might be comfortable with logging in to every visit, other groups might prefer going to their provider in person. Think about a patient who is scared and battling a life-altering disease. The human connection of sitting with a doctor, understanding treatment options and talking through what it means to join a trial is crucial for ensuring patients receive the best quality care possible. That human connection is vital, and for many populations, those conversations need to happen in person. Finding the balance between technology, trust, and the human connection is crucial to ensure clinical trials are accessible to all.
At PSI, we work a great deal in oncology, oncohematology, inflammatory bowel diseases, certain neurological conditions, such as MS, as well as infectious diseases. We also mostly work in pivotal registration phase II and III clinical trials. In most of these therapeutic areas, it is difficult to design a virtual registration trial where patients do not have to show up at the clinic for critical assessments. We would, of course, try to reduce the "unnecessary" visits through accommodating as many assessments as possible through wearable devices and home nursing, but avoiding on-site visits in a pivotal registration clinical trial is hardly ever possible. Thus, the human connection with the physician for both the patients and the CRO staff remains critically important.
How is any modernization of clinical trials, particularly in the use of technology, dependent on the traditional infrastructure of a clinical trial, i.e., sites and the staff working in them?
Modernization almost fully depends on the infrastructure already available at the site. And infrastructure varies greatly from site to site and state to state. In fact, there is no standard that every site abides by when it comes to the exact amount, type, or depth of technology available. It depends on the CRO not only to know the options at each site, but to advocate for them as well. For example, at some sites Electronic Health Record (EHR or EMR) systems are the standard, while others still rely on paper documents and manual data filing. At PSI, our Clinical Research Associates (CRAs) are viewed as site supporters. They go the extra mile to ensure that each site is supported in the way best needed for that individual team. With that same thought, the CRA would instantly know whether a site relies on technology and EHR, or if they have more manual processes as mentioned before. Modernization is a move in the right direction, but that path can only continue if bespoke support and service is provided to each site that is selected because of their potential to enroll patients into the given trial. In other words, if the sites see the patients eligible for a particular protocol, we have to find a way to integrate them within their current state of technological savviness.
In the context of this topic, please discuss patient centricity, and how does PSI emphasize it?
One of our mantras is "every patient counts." It's one that we all live by each day — it's built into our culture.
For example, we run many studies in ulcerative colitis and Crohn's disease and we know how vulnerable these patients are. For many patients, travel to sites can be problematic. We know that site visits are necessary, but we also know that traveling to the sites can sometimes be uncomfortable for the patient. A solution? Helping to arrange medically qualified transportation with a staff member that understands what that patient is facing. Having said that, it's an expensive exercise, and not easily implemented everywhere. And, it's a balance of both technological innovation, and human connection. But still - we can start small and build it up site by site.
To be patient-centric, one needs to imagine themselves in the patient's shoes. How would you feel if you had to go in for a blood draw and/or vitals check-up every week, while having a stage IV lung cancer? Which visits can be eliminated altogether, or maybe moved to the patient's home? The more we ask these questions of ourselves as we design study protocols, the more patient-centric our studies will be.
Where do you see the role of CROs in this balance between traditional site infrastructure and technology modernization and integration?
CROs have to be the leading voice of support for sites in the clinical trial process. Each CRA is an ambassador, knowing the ins and outs of the site, the site team and the unique capabilities of their site. CRAs are the ones to help train the site staff on technology integrations, provide support in any transitions and ensure that the site has access to needed information. If a site chooses to go fully virtual, or to telemedicine visits only, our teams can step in and support. Alternatively, if a site chooses not to adopt any virtual options, we can still be a strong partner for trial success. With whichever route a site chooses to take, the CRO should act as a strong partner within the guidelines of each unique site.