We Must Bring Clinical Trials to Our Communities, Burris Says

If oncology clinical trials want more robust, diverse enrollment, there's a simple answer, according to the current president of the American Society of Clinical Oncology (ASCO):

Go where the patients are.

“It's clear that it's very, very important we think about how we take trials to our patients. The vast majority of patients are seen in a community setting. And the time is right. We've seen a great experience with telehealth over the last few weeks. We've seen remote data monitoring and remote data capture. So we really are in a place now to not lose momentum,” said Howard A. “Skip” Burris, MD, FACP, FASCO, during “The Now & Future of Clinical Trials in the Community Oncology Setting” on the final day of this year’s Community Oncology Conference.

Clinical trials are notoriously difficult to qualify for. Some are even shut down before they begin due to inadequate patient accrual. But these are not the only issues holding them up. According to Burris, chief medical officer and president of Clinical Operations, Sarah Cannon Research Institute; partner, Tennessee Oncology; and 2019-2020 president of ASCO, these are the top challenges in clinical research today:

• Vast numbers of trials
• Rare mutations
• Education
• Expansion cohorts
• Eligibility criteria
• Trial complexity
• Overwhelming paperwork
• Data, both its volume and interpretation

What can be done to remedy these issues? According to Burris, we must change how we focus on the patient. Because their participation in clinical trials is nonnegotiable, all aspects of the trials—from their design to their data accrual to their results—come down to the patients, and we must focus on them: increasing their numbers, electronically capturing their consent, monitoring them remotely, capturing their data, and molecularly profiling their disease. In essence, the clinical trials process needs to change.

“I do think that we're at a place right now with the pandemic, with COVID-19, that we're going to see acceleration of modernizing the clinical trial process,” he noted.

Why do we need to profile patients?

Much of Burris’ session today centered on the unmistakable role of molecular profiling in helping to move the clinical trial process forward: It often drives participation in clinical trials and is necessary. Why exactly? Here are his top 3 reasons:

• For the patient/individual benefit
• For clinical research/drug development (trial accrual)
• For cancer research/benefit of all (biology, drug resistance)

“How do you not do broad-based molecular profiling?” he asked, noting the great need to aggregate data to better understand, for example, just why patients resistant to a certain course of therapy are resistant to that therapy or why some respond better than others. The biology of a cancer is quickly outpacing the site of origin of that cancer as the No. 1 factor directing clinical choices in how to treat patients.

Driving much of this data gathering is the increasing numbers of diagnostic studies.

“For our community practices, being able to profile our patients, aggregate that data, and understand whether you have that [trial] population is going to be critical to interacting with pharma and biotech on whether you're a great site or participating in a clinical trial,” Burris stated.

“This is the new role of data,” he pointed out, “and that enables us to provide clinical decision support and to bring these trials to our patients.”

At Sarah Cannon, Burris said their objectives for wanting to bring clinical trials to the patients, instead of making them travel to the sites, are 2-fold:

1. To allow more patients and treating physicians access to exciting clinical trials by bringing earlier-phase research and novel trial designs to the traditional late-phase clinics
2. To contribute to accelerated drug development by opening large expansion cohorts in the clinics where the patients are being seen

What is needed to bring clinical trials to the patients?

Waving a magic wand won’t help, and hospitals still need to be close by in cases of cytokine release syndrome or for occasional overnight observation.

Therefore, in order to bring the trials to the patients, the proper infrastructure must be in place, Burris noted. This will require significant investments in the clinical trial pipeline, regulatory measures, safety, contracting and budget services, site development and management, central internal review boards, quality assurance, IT capabilities and support, and marketing support.

The IT systems, in particular, must have the abilities to capture e-signatures needed to route and execute documents, allow parties to post and access trial materials, perform molecular profiling to patients can be matched to the most appropriate trials, and act as an electronic medical record to capture patients visit information. Essentially, they are the clinical trial management system.

“We’ve got to be able to gather the data remotely,” Burris stressed. “Being able to take care of patients with telehealth, being able to include clinical trials for patients and sites with the use of virtual technology and digital technology, the remote monitoring for clinical trials has long been there, and with the crisis, we've actually had to implement that full speed.”

He wrapped up by reiterating that COVID-19 has changed biopharma and clinical research in 5 fundamental ways.

1. There will be a renewed interest in vaccines.
2. There will be more adoption of artificial intelligence.
3. There will be a rapid increase in automation.
4. There will be more virtual and digital clinical trials
5. There will be increasing regulatory flexibility.

“It’s just clear that this pandemic is paving the way that we’re going to have the ability to include more patients, include more practices, and include more physicians and participants in cancer research,” he said.