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New Opportunities in Clinical Trials and Drug Development After COVID-19

TOP - July 2021 Vol 14, No 4

The process of clinical trials underwent a dramatic transformation amid the COVID-19 pandemic, according to Heidi D. Finnes, PharmD, BCOP, FHOPA, RPh, Senior Manager, Pharmacy Cancer Research, Mayo Clinic, Rochester, MN. Pharmacists must see this as an opportunity to evolve patient care in clinical trials long after the pandemic is over, Dr Finnes suggested at the 2021 Hematology/Oncology Pharmacy Association Annual Conference. She outlined efficiencies in pharmacy practice that should be enacted to accommodate changes in the way clinical trials are being conducted—such as remote patients and adverse events monitoring, mailing of the investigational drugs, and telehealth visits with study participants.

Before COVID-19, said Dr Finnes, the conduct of all clinical trials required patients to travel—often great distances—to the clinical trial sites. Once at the institution, patients were seen by a multitude of providers, including a variety of physician specialists, pharmacists, study coordinators, technicians, and an oncologist, to determine the patient’s eligibility for the clinical trial.

“Patients who were deemed eligible then remained on site for a few days to receive the investigational drug before traveling a great distance back home, completely worn out from the entire process,” she explained.

In March 2020, a survey by the American Society of Clinical Oncology of the impact of COVID-19 identified several challenges in the conduct of oncology clinical trials, including inability of patients to travel, limited ancillary services (eg, decreased positron emission tomography scans, computed tomography scans, and radiology services), and increased time with sponsors spent modifying the procedures. More than 90% of the survey responders indicated that the biggest need for healthcare teams to conduct clinical trials in the future was to allow telehealth visits. The ability to conduct remote review of a patient’s symptoms, remote site-initiation visits, remote patient monitoring, and remote laboratory data collection were also identified as changes that will create a more patient-centered approach.

To optimize clinical trials for the future, Dr Finnes said, providers must investigate new and inventive care-delivery methods. This means continuing many of the remote practices that were instituted during the pandemic.

“Unfortunately, at my institution, informed consent requires the patient to travel to our site,” she said. “Why can’t this be done remotely, so that the patient can take their time and review consents with their family in the comfort of their own home?”

Dr Finnes emphasized that eligibility criteria for clinical trials should resemble real-world experience instead of selecting patients with the best performance status. “Many of the patients we treat on clinical trials do not resemble the patients we see in practice,” she said. “Adapting clinical trials to include real-world patients will require changing eligibility criteria.”

Dr Finnes noted that investigational drugs can now be mailed overnight to patients and administered at home, saving valuable time for patients and for providers.

“We’re going to see a shift in how drugs are given to patients,” she said. “In Minnesota, where I live, patients can’t get here in the winter months due to snow and ice. The mailing of investigational products provides so much more convenience.” In addition to encouraging remote assessment with local oncologists and reevaluating the frequency of safety assessments, clinical trials should also consider alternative methods to assess safety.

“One of the things we need to embrace is wearable technologies, such as blood pressure cuffs and temperature monitoring systems, and have patients report back via different devices,” said Dr Finnes. “Although patients may have to come on site for efficacy assessments, greater flexibility is needed. These assessments could be triggered, for example, with surveys or surrogate efficacy markers.”

Whether it is virtual visits, remote monitoring of adverse events, or remote laboratory data collection, new clinical trial conduct will create opportunities for pharmacists to participate and assume some of the workload of oncologists. According to Dr Finnes, preparing for this reality will require a shift in focus to patient-centered care.

“If Amazon can deliver groceries to our front door, why can’t we bring pharmacy services to the patient?” she asked. On the operational side, these changes will include mailing oral investigational drugs, partnering with specialty pharmacies, couriers, and home healthcare agencies. All of this could expand the reach of pharmacy services.

“If the patient doesn’t have to come to us, we could include patients in Abu Dhabi, for example, on a clinical trial at our site through these telehealth and electronic capabilities,” she suggested.

On the clinical side, the pharmacist will play an important role in helping the cancer care team monitor patients, including virtual medication reconciliation, drug interaction screening, counseling, and toxicity assessment. “We need to embrace technology, be innovative in delivery of investigational product, and collaborate with government and industry partners,” Dr Finnes concluded. “If we do that, we’ll be able to mobilize and expand the breadth at which patients can receive life-saving therapies for clinical trials.”

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