Ruesch Symposium Seeks ‘Common Threads’ Around Clinical Trials

Posted in GUMC Stories

For researchers, the benefits of enrolling patients on clinical trials are evident: more participants leads to more robust trials and richer data, and these data then inform and improve tomorrow’s treatments.

Clinical trials are the engine of medical breakthroughs, many researchers say.

But what about the patients? What is in it for them?

This was one of the key questions explored in depth at an annual symposium held November 30 and December 1 at Georgetown University by the Ruesch Center for the Cure of Gastrointestinal Cancers at Georgetown Lombardi Comprehensive Cancer Center.

The two-part symposium, titled “Fighting a Smarter War Against Cancer: Empowering Patients Through Clinical Trials,” focused on science and policy on the first day and on patients and caregivers the second day.

What is in it for Patients?

Bloomberg News Executive Editor Amanda Bennett, whose memoir The Cost of Hope chronicles her late husband’s experience with cancer and clinical trials, challenged a panel of clinicians, researchers, patients, regulator and patient advocates to answer the question: What is in it for patients?

Today, only about three percent of all adult cancer patients in the United States—and far fewer minorities and medically underserved—enroll on clinical trials; the critical issue is how to engage patients who might not immediately see the benefit to them.

Bennett further encouraged the panel to consider: “Is the patient well served by these trials?”

Cynthia Langwiser, a Georgetown Lombardi patient who sat on the panel, said she became comfortable with the idea of enrolling in a clinical trial after her physician spent a while explaining why her trial was a good fit for her. She felt assured that it was in her own best interest, and not just in the interest of science.

“My doctor talked to me at length about why this was a good trial for me. You need that personal interaction to understand the reasons,” Langwiser said.

‘Common Threads’

Throughout the day, speakers approached the issues from an array of perspectives. Regulators from the U.S. Food and Drug Administration concerned with safety and efficacy, payers concerned with costs, pharmaceutical companies concerned with access to high volumes of patients and high quality data, and oncologists – who may have different objectives depending on where they practice and the standards to which they are held, each bring unique perspectives to the table.

The objective of convening the diverse group was to find the points of alignment in such a complex tangle of issues, according to John L. Marshall, MD, who directs the Ruesch Center and heads the hematology/oncology division at Georgetown Lombardi.

“Why are we having such trouble moving the bar forward, when there is a clear need to have more patients participate in clinical trials?” Marshall said. “Our system is fragmented; we each have our own agendas and our own lobbies. We need to come together to listen to one another, respect each other, and find the common threads to influence the pace of curing cancer.”

The Long Journey from Conception to Completion

Deborah Schrag, MD, MPH, delivered the keynote Thomas R. Schafer Memorial Lecture. Schrag, who is associate professor in the department of medicine at Harvard Medical School and a specialist in gastrointestinal cancers, framed her talk around a specific clinical trial to demonstrate the multitude of barriers physicians sometimes face when initiating clinical studies.

Schrag’s talk was met with audible murmurs of recognition from many in the audience as she walked through the many real-world, practical considerations that threatened to derail her study at every step. While she was able to initiate the study, in six months it has accrued only 17 patients due to a litany of reasons ranging from institutional culture to cost barriers to regulatory hurdles, both small and large.

“From conception to execution to completion, [starting a clinical trial] is a very long journey that requires a lot of stamina and fortitude. It is not glamorous,” Schrag said.

Keeping Patients at the Center

Schrag highlighted the importance of maintaining a patient focus throughout the entire process of planning a clinical trial to execution to avoid many of the procedural and more substantive pitfalls.

“The patient should be right in the center – that’s where they need to be. We need patients and families to be more active and more engaged in all phases of clinical research from planning to execution,” Schrag said.

She also dispelled the notion that a trial must be highly lucrative or produce a new blockbuster drug to be worth doing.

Sometimes just asking the right scientific questions regarding the benefits of paring down treatment options is worth pursuing if it could result in less toxicity or a better outcome for the patient, she said. This was the example in her study, which asked the question of whether radiation is necessary or beneficial in all patients with stage 2 or 3 rectal cancer.

She called for simplification of all aspects of clinical trials to make the process less cumbersome for researchers, and less off-putting for patients.

Marshall underscored the need to simplify enrollment when he addressed patients and caregivers on the second day of the symposium.

“We are spending a bucket load of money on cancer in this country. We are doing lots of tests, and we give lots of medicine. Yet our outcomes are not much better,” he said.

If researchers are going to innovate and bring new therapies to the table, Marshall said, it will entail “cleaning out the closet” of existing therapies and paring down existing treatments – which will require exactly the sort of trial that Schrag described.

Georgetown Lombardi patient Robert Pastor, PhD, who also sat on the panel, called on his fellow panelists to find a way beyond these challenges in order to move cancer treatment forward.

“Doing science through clinical trials is the most important thing we can do. Stop wasting patients’ time, stop wasting their health” with drugs that are ineffective or overly toxic, he said. “Personalized medicine is the future, and we are doing it already, but we need to be doing it better.”

By Lauren Wolkoff, Georgetown Lombardi Communications

(Published Dec. 16, 2012 )