Opportunities for Pharmacists in Clinical Trials Amid COVID-19 and Beyond

Prior to the COVID-19 pandemic, patients were often required to travel, sometimes great distances, to partake in a clinical trial. At the trial location, patients had to meet with various physician specialties, nurses, pharmacists, study coordinators, and others.

“All to see the oncologist…to determine if the patient is eligible for the clinical trial,” said Heidi D. Finnes, PharmD, BCOP, senior manager, Pharmacy Cancer Center Research, Mayo Clinic Cancer Center in Rochester, Minnesota, in a session held virtually on April 14, during the Hematology/Oncology Pharmacy Association (HOPA) Annual Meeting 2021. The process can be exhausting for patients, who, after extensive traveling and a string of meetings, blood draws, and scans, might not even be able to participate in the trial. During the session, Finnes discussed how to accommodate changes to clinical trial conduct in the oncology setting amid the COVID-19 pandemic.

The American Society of Clinical Oncology (ASCO) conducted a survey in March 2020 on the impact of the COVID-19 pandemic on oncology clinical trials. “What they found is that each institution had to create their own COVID-19-specific procedures and really scramble to figure out how to get patients on clinical trials, drug safely, and monitor patients safely via the use of remote symptom monitoring, site initiation visits and audits,” Finnes said. Other clinical trials were halted until sponsors and investigators could determine the best path to safely conduct the study.

According to the results of the ASCO survey, the following are the most prevalent challenges in conducting clinical trials during COVID-19:

• Decreased willingness or ability among patients to participate (56%)
• Limited ancillary services (52%)
• Time spent with sponsors to modify trial procedures (52%)

The ASCO survey then gauged health care teams’ needs for conducting future clinical trials, “whether it be for future pandemics, but also just to be prepared and create a more patient-centered approach to clinical trial needs.”

Allowing telehealth visits amassed the biggest response, with over 90% of respondents identifying this need for their health care teams. Other responses highlighted the need for remote work, including remote review of symptoms, SIVs, monitoring, and lab collection.

Finnes, with the HOPA Investigational Drug Services (IDS), has considered the changes necessary for future pharmacy practice in response to the challenges faced during the pandemic, including:

• Virtual monitoring visits
• Virtual site initiation visits
• Virtual audits
• Mailing of oral investigational product

“In my institution in 2020, we mailed more than 600 prescriptions for individual patients alone,” Finnes said. Patients reported a lot of positive feedback on this development, according to Finnes.

As for optimizing clinical trials for the future, Finnes highlighted creating new health care delivery methods and prioritizing patient-centered clinical trials. “More of our patients who are receiving oral therapies and immunotherapies continue to work and continue to do all the things associated with family life at home, so how can we make things more centered around the patient? Can we continue these remote monitoring practices that have been put in place?” Finnes inquired.

Finnes also stressed the current practice of informed consent, where patients have to sign in the presence of a physician of other staff before being enrolled in a trial. “Why can we not do this remotely, so that the patient can review with their family in the comfort of their own home?” Finnes probed.

Other methods for optimizing clinical trials for the future:

• Ensure eligibility resembles real-world experience.
• Allow virtual visits/assessments.
• Transfer investigational drug product (IP) to the home.
• Offer education for home administration of IP.
• Optimize dispensing of IP, including home health care.
• Consider alternative methods to assess safety, such as wearable technologies.

“The future of clinical trials is patient-centered care,” Finnes stressed.

For pharmacists, Finnes explained that it is necessary to bring pharmacy services to the patient. “To do that, I think we’re going to have to change both our operational and our clinical practices,” Finnes said.

For investigational drug product delivery, pharmacists can potentially mail oral investigational drugs and partner with specialty pharmacies, couriers and home health care agencies.

“I think the pharmacist is going to be key in helping the health care team manage these patients on clinical trials and doing some of these virtual medication reconciliations, drug interaction screening, and counseling,” Finnes said. It will be key for pharmacies, HOPA, and other associations to encourage new and inventive pharmacy practices for patients in clinical trials to meet the needs of these patients and to increase participation in future clinical trials.

Reference

1. Finnes H. Oncology Investigational Drug Development: What’s New in Our Armamentarium and How Has Clinical Trial Conduct Changed Post-COVID-19? Presented at: Hematology/Oncology Pharmacy Association 2021; virtual; April 14, 2021.