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By Gerard Barron, Vice President of Operations, Illingworth Research Group, a Syneos Health Company
“How Are Savvy Patients Becoming a Force to Be Reckoned With When it Comes to Reshaping Clinical Trials?”
- Today’s Trial Design Starts with Patient Centricity
Patients are better educated on the workings of clinical trials—and more demanding
- Savvy Patients: A Force to be Reckoned With
Patient demands are reshaping clinical trial designs
- The New Model: Bringing the Trial to the Patient
The direct path to simpler recruitment and stronger retention
Gerard Barron is experienced in all phases of clinical trials. He has a keen interest in trial innovation and patient-centricity. His role focuses on the delivery of patient centric solutions to facilitate participation in clinical trials for all.
Over the past year, as fear of COVID-19 threatened to shut down clinical trials worldwide, sponsors, sites, and clinical research organizations (CROs) had to get creative in adopting patient monitoring techniques that required less travel, less human contact, and, overall, less exposure to potential sources of disease. Home-based trials went into overdrive. And patients found they liked it.
Now, even as the world begins to return to “normal,” patients’ expectations for clinical trial participation may have changed forever. The industry will need to take heed and adapt.
The rise of the patient: Knowledge is changing the power dynamic.
With the race for a COVID-19 vaccine and treatment dominating news cycles over the past year, people who previously had only the vaguest notion of clinical trials now have a greater understanding. They are aware of recruitment, safety and efficacy, and adverse events. In parallel, the rise of technology means that they are also cognizant of many of the techniques used to simplify trial participation.
For instance, wearables and mHealth apps are part of daily life. People self-test, self-monitor, and self-report with aplomb. Telehealth visits have usurped long waits in doctor’s offices. And tests that require in-person medical expertise can be administered by mobile research nurses who come conveniently to the patient, wherever that may be.
Going forward, savvy patients who consider this to be normal operating procedure will begin to shape trial structure through their demands. To aid recruitment, ensure compliance, and support retention, sponsors will need to consider all the ways they can make a trial easy and attractive for participants. Step one: Bring the trial to the patient.
Seeking safety. Convenience. And the comforts of home.
Trials that require minimal travel and include all the comforts of home are appealing to patients for many reasons.
Safety, of course, is a key concern. Patients feel that their home is a safe space. That is critically important for vulnerable patients with severe symptoms or threatening co-morbidities. Clearly, they prefer to stay in their controlled home environment rather than to expose themselves to public situations filled with unknown contaminants.
Almost more pressing are the economic savings and family benefits of having a trial come to them. Patients with full-time employment may have trouble getting time away from work—or may have their pay docked. There is an analogous issue for caregivers who have additional full-time jobs. Patients and caregivers may have to pay travel expenses out of pocket or have trouble with the paperwork necessary to be reimbursed. Those with young children at home have to factor in childcare. Self-monitoring using remote technologies—or even squeezing in a clinical trial visit from a nurse who rings their doorbell and stays for an hour—provides a level of convenience and ease that patients crave. Knowing this is possible, they find the old model even less agreeable.
Case in point: We were recently called in to help with an acute stroke study. The first two patients enrolled in the study were both planning to drop out; they wanted to go home, instead of to rehab as the study protocols dictated. Only by engaging mobile research nursing to manage care and monitoring in the patients’ homes was the sponsor able to continue the study.
A trial starts and ends with the patient
While sponsors want to be patient-centric, they are also concerned with practical matters. Will data quality be impacted? Will there be added costs? How can they retain control? That is understandable. Fortunately, there are proven solutions—both technological and human. These tools and strategies that have been honed for years in rare disease trials have become mainstream over the last year. Mobile research nursing, for instance, has gone from a perceived luxury to an expectation in the eyes of many patients. And patient opinions are critical. Because without patients, there is no trial.