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Clinical Trials at Home Pave Way for Greater Patient Access

Clinical Trials at Home Pave Way for Greater Patient Access
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Published on May 12, 2021

What Are the Benefits of a Clinical Trial at Home?

In the early days of the COVID-19 pandemic, many people quickly turned their homes into offices and classrooms. Home also became the site of care for some patients undergoing cancer treatment.

Telehealth visits ramped up significantly during COVID-19. During the first quarter of 2020, the number of telehealth visits increased by 50%, compared to the same period in 2019, according to the Centers for Disease Control and Prevention (CDC). Telehealth is evolving and patients with cancer can access many types of medical care without leaving home, including participating in a clinical trial. Through home-based clinical trials, certain tests can be conducted by a mobile research nurse, test results can be accessed online, and doctors can be seen via Zoom.

Patients Prefer Care Close to Home

A 2017 report from the Center for Information and Study on Clinical Research Participation (CISCRP) found that location was second on the list (after the possibility of receiving a placebo) of things trial participants disliked about clinical trials.

Increasingly, patients are able to participate in decentralized trials. Aside from occurring outside a single location, these types of trials have other differences, such as the way they collect and store patient information so that it can be seamlessly shared across research institutions. Data collection methods — the ability to directly collect data using digital technology from electronic medical records, patient monitors, and more — remove the “intermediary” on the clinical trials team who records information from a variety of sources into a case report form, explained Julie R. Gralow, MD, Chief Medical Officer, American Society of Clinical Oncology (ASCO).

Decentralized clinical trials enable more people, including those typically in underserved communities, to participate, which results in a richer, more inclusive data set of people with certain cancers, according to ASCO’s recent “Road to Recovery” report, published in the Journal of Clinical Oncology. Getting care at home, or closer to home, can also offset some of the expenses of getting to and from large cancer centers, research suggests.

Data security is also of the utmost importance and research teams should work hand-in-hand with information technology professionals to ensure that data collection is safe and secure, while maintaining patient privacy during decentralized trials, according to ASCO’s “Road to Recovery” report.

Clinical Trial Expert Champions Home-Based Care

Steve Cummings, MD, is a leading expert in designing clinical trials and how to conduct trials from home. He’s also the Director of the San Francisco Coordinating Center and Emeritus Professor of Medicine and Epidemiology at U.C. San Francisco. In a recent article in JAMA Internal Medicine, he outlined how clinical trials can be conducted without patients ever having to step outside of their residence. These innovative designs have a lot of benefits, he explained.

“Conducting trials from home instead of a limited number of clinic sites could allow people with a condition to participate from anywhere in the United States at any time. Many things can be done from home, including giving the treatment, drawing blood specimens, and doing simple exams, like blood

pressure and electrocardiograms,” Dr. Cummings said. “Trials done at home, instead of in clinics, save a participant a lot of time, stress, and money for things like transportation, parking, food.”

The challenge is building and maintaining a strong doctor-patient relationship, but it can be done, he said.

“Without face-to-face visits, it is important that participants feel that they have a relationship with the study and staff to care about continuing in a trial and doing things well and on time,” he said.

A Telehealth Win for Patients

Ruth Fein Revell, advocate and patient with myeloproliferative neoplasms (MPNs) — a group of blood cancers that occur when the body creates too many white blood cells, red blood cells, or platelets — began a clinical trial testing a new therapy in January 2020. But by mid-March, when New York was reeling from climbing COVID-19 cases, Ruth became uncomfortable traveling to a New York City hospital 3.5 hours away from her home.

“Every three weeks I get blood work and see my MPN specialist, Dr. Ellen Ritchie at Weill Cornell. I began to get my blood work done at my local hospital, followed by a televisit with Dr. Ritchie. I still needed to go into NYC every nine weeks for an MRI and twice for an updated bone marrow biopsy. This flexibility was extraordinarily helpful, giving me less COVID-related stress as a patient,” she said.

From Ruth’s perspective, the telehealth model worked during the initial COVID-19 crisis and continues to be convenient for her.

“The benefits were enormous in the middle of a pandemic,” she said. “The challenges were on the practitioners’ end. They made it very easy for me as a participant in the trial. I believe the medical profession, and hopefully, insurers will continue to see how this transformative practice is beneficial to all.”

The Future of Clinical Trials

Going forward, ASCO recommends continuing the positive changes that have occurred during the COVID-19 pandemic, including, “facilitating patient participation in research through telehealth encounters, allowing the delivery of research-related care at clinical sites remote from research centers and closer to participants’ homes, and increasing flexibility in protocol requirements,” according to the “Road to Recovery” report.

Another positive consequence of the pandemic is that research procedures became more patient-focused, according to the ASCO report, and continued modifications will enable more patients from diverse populations to participate in clinical trials going forward.

~Lauren Evoy Davis

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Sources:

  1. Trends in the Use of Telehealth During the Emergence of the COVID-19 Pandemic — United States, January–March 2020. Morbidity and Mortality Weekly Report. CDC. Published: October 30, 2020 69(43);1595–99.
  2. 2017 Perceptions & Insights Study: Public and Patient Perceptions of Clinical Research. The Center for Information & Study on Clinical Research Participation. (CISCRP)
  3. Khozin S and Coravos A. Decentralized Trials in the Age of Real-World Evidence and Inclusivity in Clinical Investigations. Clinical Pharmacology & Therapeutics. Published: July 2019.
  4. Cummings S. Clinical Trials Without Clinical Sites. JAMA Intern Med. Published: March 1, 2021.
  5. Pennell NA, Dillmon M, Levit LA, et al. American Society of Clinical Oncology Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care. J Clin Oncol. Published: December 10, 2020.

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