By Rob Weker, with Mary Stober Murray
Our healthcare system is under a tremendous, immediate, and previously unimaginable strain, a tsunami of sorts:
- an economic crisis on par with the Great Depression;
- a healthcare pandemic that travels in Harry Potter’s Cloak of Invisibility, only revealing itself in massive infection rates and unnecessary deaths; and
- calls for social justice and an end to differential treatment and access based on race.
Yet we are also in the midst of a technological revolution. Telemedicine and virtual clinical trials present an opportunity to transform the delivery of medicine. The pandemic has thrust industry, sites, regulators, and providers into incorporating these new forms of delivery. Patients like me have been thrust into this new world, too.
We stand at a crossroads. We could opt to return to old paradigms once the pandemic has stabilized, or we could leverage the opportunity for transformation. The pandemic has launched us into telemedicine and demands for social justice call us to redouble our inclusion efforts. Now is the time to raise our voices so that the new digital clinical trial infrastructure inclusively meets the needs of all patients. Patient-centricity, quality, and inclusion are not natural consequences of the shift to virtual clinical trials. To be intentional with the design, we must start with articulating and understanding the full contexts of patients’ lives, medical and beyond.
Considerations for healthcare delivery and clinical trials relate to specifics of the medical interaction and treatment intervention, and others relate to the social factors in my life, such as my housing, my job, and my family demands.
Medical Interaction And Treatment Intervention
1. Doctor-patient relationship
I have been with my oncologist for six years. She knows what I’m going to say or ask before I do, and we have a rapport that makes telemedicine a viable option. Even so, it’s still not the same during the pandemic. Dr. Kim Reiss Binder, an oncologist at the University of Pennsylvania, wrote in an article “…. all of my ways of supporting you during this pivotal moment — leaning in, offering a hand or a hug — have been stripped away in the name of safety.”1
This is the current reality of the cancer patient-oncologist relationship during a pandemic. There may be a bit of trepidation in starting the relationship virtually, be it starting on a clinical trial or seeing a specialist for the first or second time. Virtual dating sites may thrive, but virtual medicine requires a sound foundation.
2. Consenting to treatment or clinical trial participation
Informed consent is a fundamental principal for clinical trial participation. Technology enables remote consenting, but is that how I want to make the decision? Many companies had been pursuing electronic consent forms before the pandemic. Does a review of the informed consent form (ICF) require a face-to-face meeting between the medical professional and the patient? Is a virtual meeting sufficient? There are not significant technical obstacles to implementing electronic consenting, but it will require changes to ways of working to ensure that patients — along with their families and their own medical professionals — are well informed in making their decision on whether to participate on the trial.
3. Office or study visit
The pandemic has forced patients and doctors into a new decision, a balancing of risk (being with others in a tight physical space) and quality (in-person vs remote appointments). There are many factors to consider:
- How critical is the appointment or study visit?
- Are there additional risks if I physically visit a doctor’s office or investigator site? Are the necessary protocols in place to keep everyone safe during my office visit?
- Is the cost of this virtual appointment covered by the payer? Until recently, many payers have been reluctant to cover such charges.
- If the visit entails medical testing that can only be done at a medical facility, such as an MRI or X-ray, then I must choose whether to defer the test. Can the testing be done at a medical facility closer to my home?
As part of routine medical care, I recently had a scheduled ultrasound but opted to defer it for two months because it was not absolutely essential at that time. The procedure was eventually performed at the hospital, but my appointments with two separate doctors were conducted remotely.
In the case of a clinical trial, the decision might already be made for me. A global survey conducted by Medidata reported that 63 percent of global investigator site respondents “stopped new patient recruitment for an ongoing trial and 43 percent said they have delayed their study” due to COVID-19 lockdowns; 45 percent said they had switched study participants to “virtual/telemedicine visits from in-clinic visits.”2
4. Administration of drug
Patients can receive their prescriptions through the mail, eliminating a trip to the pharmacy. Additionally, if any vital signs or simple testing are required, this can occur via wearable technologies. Why stop there — can you imagine sending a nurse to a patient’s home to deliver chemotherapy? Well, it’s happening.
This concept applies to clinical trials, too. Clinical supplies can be and are being sent directly to the patient — no site visit required, but the burden on patients and caregivers of self-administration must be considered. A pill is one thing, but a subcutaneous injection is another. Once again, we need to understand our patient and his/her preferences and capabilities in tailoring a solution that is inclusive and manageable.
Beyond Medical Matters
As Walt Disney stated, “In this volatile business of ours, we can ill afford to rest on our laurels, even to pause in retrospect. Times and conditions change so rapidly that we must keep our aim constantly focused on the future.” Considerations of patient context in a digital future must include social factors.
I once participated in a workshop with a pharmaceutical company that focused on virtual medicine. I indicated a comfort with technology and was quite open to engaging virtually, but as a patient, I wanted the communication to be “two-way” — not only would I provide information into the system but information would be shared back to me in a timely manner.
However, I soon realized that my perspective was too limited. A site operations director in the workshop made a point that continues to resonate: “I work in Lancaster, PA, and many of our patients are Amish, so technology will always be an issue for us. Whatever the solution, we must be able to deliver it in a low-tech way as well.” There were no insurmountable technical obstacles to preclude virtual interactions, but the reality in Lancaster was this technology would not be adopted. Other populations, such as those aged 65+, may require similar low-tech strategies to include them in clinical research. Caregivers may need technology training and support to facilitate participation.
Low-tech and virtual strategies have one thing in common: Patients need to have a stable home to enable their participation. The pandemic has created an upheaval in housing, with 30 to 40 million American renters facing potential eviction by the end of the year.3 This housing crisis disproportionately impacts communities of color, families with children, and women of color.4 The social, economic, and health implications of housing instability go well beyond clinical trial participation. I mention it here because many pharmaceutical companies are pursuing diverse representation in clinical trials for COVID-19 and other chronic diseases. Housing instability represents an imminent and substantial threat to the success of these efforts, especially in urban areas where academic research sites are located, such as Boston.
7. The digital divide
While telemedicine has great potential to widen access, the early data indicate adoption of these technologies differs along demographic lines, specifically age and race/ethnicity. Some patient populations do not have access to basic infrastructure needed to deliver some of the technology-enabled solutions. All patients do not have high-speed internet access or a smartphone and many are not comfortable with new technology. Studies show a digital divide persists among populations in adoption of technologies such as patient portals.5 A patient with poor eyesight will quickly become frustrated completing a questionnaire on his/her iPhone. A patient whose first language is not English may feel more comfortable expressing themselves in person or require an interpreter for the telemedicine visit.6 We need to design and implement solutions that can meet the needs of a highly variable patient base.
8. Family demands and logistics
For visits to be conducted virtually in the patient’s home, we must consider the family’s demands on that space and time for working at home (patients and caregivers) as well as remote schooling. Caregiver considerations should be given the same weight as the patient’s; the caregiver often carries the burden of the disease, trying to maintain familial normalcy, and enabling the trial. What is the impact on the caregiver and her/his schedule? Does childcare need to be organized? The decision to participate in a clinical trial is complicated. Patients are focused not only on the medical aspects of the trial but also on the psycho-social impacts. I don’t want to add to my family’s burdens, and I am very sensitive to the impact my medical care has on them. We try to make a holistic decision that considers all of these elements.
9. Career, work, and affordability
Work is a source of health insurance benefits, income, and feelings of self-worth. I recall the words of a cancer survivor speaking at a conference who broke down in tears as she told the story of her 70-year-old mother, who came out of retirement to support her daughter and grandson while the daughter endured cancer and treatments. “I can live with the ups and downs of cancer,” she said. “I can’t live with not being able to support my family.”
During my treatment and clinical trial participation, I continued to work, taking advantage of the family leave and flextime provisions available at my employer. Not everyone is so lucky. Nearly 50 percent of the U.S. workforce is employed in small business.7 Communities of color have been disproportionately impacted by the economic impacts of the pandemic. The Migration Policy Institute reported in March 2020 that 6 million immigrants lost their jobs in restaurants, hotels, and home healthcare industries, while another 6 million are essential workers, such as grocery store employees.8
These workers, who are so vulnerable to COVID-19 infection and hospitalization, may be candidates for clinical trials [COVID-19 or chronic disease] themselves, or they may be caregivers, but they may also lack the employer-based benefits and flexible work schedules that enable participation.
Sponsors, sites, and even employers have to recognize the critical importance of work to patients and caregivers and provide flexibility in study designs, site facilities, and work schedules/locations to enable participation by people in various job sectors, settings, and income levels. Research staff conducting the informed consent process should note the costs that are covered by the study and those that are not, particularly differentiating between telemedicine visits that may be part of the study and those that are part of routine care. How will medical expenditures that are considered “experimental” by payers be addressed in the future? A site-based patient navigator can help patients through complex choices related to family leave and long- and short-term disability and insurance coverage. Bottom line, the patient is looking for financial transparency and flexibility regarding work.
The pandemic has created both challenges and possibilities, shifting our understanding of risks and benefits for patients. Pre-pandemic, patients had some infection concerns around going to the hospital or doctor’s office for an appointment, but now the risks are dramatically increased with a highly contagious, serious disease. The safest option is to avoid these settings but at the same time, there are risks associated with delaying medical appointments or conducting these remotely.
COVID-19 impact and response also vary country to country and state to state. The challenge for drug developers and medical providers is to deliver quality care while simultaneously managing the overall risk in the context of a patient’s circumstances.
As a patient advisor to pharmaceutical and medical device companies as well as provider organizations, I am particularly concerned with articulating how we as patients perceive risks and benefits of virtual clinical trials. I am paying special attention to how hybrid or virtual clinical trials are inclusive of diverse patient contexts and needs, especially during this pandemic, so it is more feasible for the patients who need them to participate. Specifically, I expect investigator sites to perform the following activities:
- Conduct an assessment of potential participants for their social determinants of health (SDOH) during enrollment, to ensure that patients have adequate housing, digital capabilities, and caregiver support to enable participation. Validated questionnaires are available to screen for SDOH, and sites need to invest in staff to screen and document these patient needs.9
- Refer patients to appropriate social organizations for additional support, via a patient navigator.
- Measure and report the impact of a switch to virtual/telemedicine or other interventions on the demographics of the study participants, specifically race/ethnicity, age, gender.
Similarly, I expect sponsors to do the following:
- Design flexible protocols that allow for low-tech provision of services as well as virtual/telemedicine. This is now allowed under COVID-19-related FDA guidance.10
- Offer services enabling caregiver support of participants in research programs and protocols, particularly for patients who are reluctant or unable to adopt digital tools.
- Tailor study execution to the needs of the populations due to the pandemic or other social needs in the geographies where the study is being conducted. Sponsors may seek to engage community-based organizations to provide support services, including patient and caregiver information.
- Select sites based on their demonstrated ability to accrue and retain diverse populations, and regularly measure site performance in these abilities, particularly as they relate to the participation of racial and ethnic minorities, women, and the elderly.
Finally, I expect my fellow patients and their advocates to own this opportunity. We must be part of the change and partner with all stakeholders. We must speak up, be active and direct this transformation so virtual clinical trials and digital health practices deliver positive experiences and outcomes for patients and their caregivers.
Shifting to virtual healthcare requires focus, transparency, and an integrated approach across all stakeholders. The patient (and caregiver) is the hub through which all spokes are connected. These learnings provide the seeds of change to jump us to the “new exceptional.” As Robert Kennedy stated, “Some men see things as they are, and ask why. I dream of things that never were and ask why not.”
About The Authors:
Rob Weker has 25 years of pharmaceutical R&D experience and focuses on providing patient insight and input in enhancing the patient experience and delivering step-change performance. He is a three-time cancer survivor, including pancreatic cancer. Weker serves on the Hospital of the University of Pennsylvania Patient and Family Advisory Council and on GlaxoSmithKline’s Oncology Patient Council. He also publishes the Through the Patient Lens blog on the patient journey. Weker is the principal at Weker Advisors LLC, providing consulting services across the healthcare industry. He obtained a chemistry degree from Cornell University and an MBA from the University of Michigan Ross School of Business.
Mary Stober Murray is a leading voice and collaboration-builder for health equity and patient engagement in pharmaceutical development operations. In her role at National Minority Quality Forum, she leads multi-stakeholder collaborative networks to improve population health using actionable research, data science, education, and advocacy. Previously in clinical development operations at Bristol-Myers Squibb, Murray brought internal and external stakeholders together to strive for positive patient experiences and diverse representation through creative patient engagement, health literacy, and best-practice frameworks. She has an MBA from Thunderbird and a master’s degree in population health from Thomas Jefferson University.