COVID-19, for all of the pain and suffering it has wrought, has driven some positive change. In the life sciences industry, for example, necessity has been the mother of adoption—spurring a notoriously risk-averse industry to shift from in-patient visits to remote interactions by embracing mobile and digital technologies. In a matter of months, researchers started to decentralize clinical trials by adopting remote consents and clinical outcome assessments (COAs) through a variety of digital applications.
One such tool is the new Medable TeleCOA™ application, which allows patients and researchers to harmonize outcome assessments captured remotely in the clinic and home. Medable TeleCOA works with Medable’s TeleVisit and TeleConsent applications to improve the trial experience for patients, sites, and sponsors.
The company recently hosted a webinar to talk about the shift to remote collection of outcomes, hosted by CEO and co-founder Dr. Michelle Longmire, along with Dr. Robert Bissonnette (CEO of Innovaderm, a specialist in dermatology clinical research), and Richie Kahn (a patient advocate and member of Medable’s Patient Advisory Council).
While decentralization is a major industry trend, Dr. Longmire and the panelists reinforced that it doesn’t necessarily mean all trials will be 100% remote. Biotech and pharma sponsors need flexible and modular solutions to enable the unique needs of a given protocol. That requires additional digital technologies to connect with a patient as early as possible to engage in the trial, from recruitment to study close.
Dr. Bissonnette noted that some clinical outcome assessments—specifically patient reported outcomes (PROs)—have often been captured remotely and electronically in many clinical trials. Before COVID-19, though, most of the other assessments were almost exclusively done in a physician’s office. Bissonnette believes many more assessments can be done remotely, and “we’ll see more and more assessments being done remotely” over time, even after the pandemic.
Factors that Determine Feasibility for Remote eCOA
The feasibility of eCOAs depends on many factors. Dr. Longmire said understanding the disease and the condition is first and foremost, followed by evaluating which COAs are needed for the protocol—and then determining which COAs are suitable for remote.
Of the four kinds of outcome assessments—patient reported outcomes (PROs), performance outcomes (PerfO), clinician-reported outcomes (ClinRO), and observer-reported outcomes (ObsRO)—PerfOs and ClinROs have traditionally been most dependent on onsite clinics.
Dr. Longmire shared that more PerfOs and ClinROs are transitioning to eCOA, but many factors determine feasibility: therapeutic area, disease, disease stage, disease prevalence, patient preference, access to technology, privacy, safety, and so on.
The panel discussed specific factors that determine remote activity, including:
Therapeutic area: Different areas of medicine require different levels of onsite care. PerfO assessments in dermatology, according to Dr. Bissonnette, can use telemedicine to a greater extent than neurology.
“Some research in dermatology should ideally be done 100 percent remote. For example, non-drug studies looking at quality of life or resource utilization or impact on work. At the other end of the spectrum, you have Phase I studies with an intravenous medication that obviously will need to be done in the research setting or environment. In between, we have many options.”
Kahn knows this firsthand from participating in research for his optic atrophy. “There are ways to collect information on visual fields to actually perform remote visual field exams at home. But every now and then you’re going to have something that cannot be done electronically.”
The need for physical contact doesn’t automatically require an onsite visit. There’s also the possibility of local nursing agencies stepping in to do things like blood work. And wearables can track a patient’s vitals even more comprehensively than less frequent onsite visits.
Disease prevalence: Finding patients with rare diseases may require more remote activity because of the difficulty recruiting. On the other hand, common conditions can often be researched onsite due to the broader pool of potential participants. For example, acne is so common that it’s easy to find patients near a research site.
Said Dr. Bissonnette: “If you do a study on a rare genetic disease, most of your patients will have to travel hours. That’s where one needs to try to do everything that is possible to avoid site visits and replace them with telemedicine visits.”
Disease stage: A patient’s condition can also determine the feasibility of remote care. “Typically in phase II-III studies, patients in the past had to come to the office for every visit,” said Dr. Bissonnette. “I would favor a hybrid model, where some visits are done at the site, some are done remotely, specifically for primary and endpoint visits where it’s a subjective evaluation.”
Customizing to Meet the Needs of Patients and Protocols
Regardless of modality, an important requirement of eCOAs is that they provide valid, reliable and meaningful endpoints equivalent to onsite COAs. This is happening more and more, while research on equivalence is still ongoing. Dr. Longmire reinforced the importance of a hybrid model that adapts to both patient needs and protocol needs. “Medable TeleCOA can connect with a patient as early as possible, on any device, to engage and enable participation in the clinical trial, from recruitment forward.”
Dr. Bissonnette noted that patients “want more and more telemedicine.” They would rather stay home than go to the physician’s office because it’s easier for them. “In the future, given the choice between two similar studies, if a study has 10 visits at the site versus another one with three visits at the site and all the other visits remotely, patients will probably favor the second study.”
Whatever COA strategy is used by a trial, focusing on patient needs should be a central design philosophy to ensure successful and sustainable studies. Said Kahn: “We are finally at a point where there’s all this momentum to decentralize trials and bring them to patients where they are and how they want to participate. … There’s going to be some stuff we get right and some stuff we get wrong. When in doubt, always incorporate the input of the patients early and often.”
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