Patient-Centric Trials: Where People and Their Stories are the Focus

Patient-Centric Trials: Where People and Their Stories are the Focus

By Administrator at 12 Dec 2018, 08:29 AM

From the ideas to the follow-up, patient-centric clinical trials put the focus on people. During these trials, cancer treatment is tailored to the unique biology, environment, and needs of each patient. Patient-centric trials give people a voice, prioritize quality of life, lift burdens of treatment, and infuse outcome successes with patient perspectives.

In the Vision

Phase I and II trials, the early stage clinical trials Gateway for Cancer Research invests in exclusively, allow researchers to engage in new drug discovery and the novel use of existing drugs, and allow cancer experts to pilot complementary and alternative therapies. Phase I studies of new drugs or technologies are usually the first trials that involve people, with a primary focus on safety, and help determine the best way to administer a new treatment. Phase II trials are conducted to determine if — and how well — a treatment works. Success may mean the cancer shrinks or disappears or that its growth slows or stops; or it may simply mean improved quality of life for the patient.

In the Design and Implementation

“The more we humanize the research, the better off we are,” says Mary Lou Smith, Patient’s Advocate, Research Advocacy Network Co-Founder and Gateway Board Member. Smith also recommends patient representatives be part of the research team. “We can make trials too complicated to understand,” she says. Layman terminology goes a long way towards staying patient-focused, she believes, as well as looking for ways to take trials to patients and their communities. “If we don’t take trials into the community, we will have answers that don’t apply,” says Smith.

Feedback about what cancer patients, their families and their care circles worry about, along with the challenges they want or need tackled, are listened to throughout the design and implementation of a patient-centric clinical trial. Personal, work or family responsibilities impacting a patient’s participation matters.  

For Dr. Dana Rathkopf, Medical Oncologist at Memorial Sloan Kettering Cancer Center, that focus means understanding the clinical trial as well as patients and their stories when exploring options with them. “I take the time to talk to patients about the trial they are considering,” says Rathkopf. “I also look for ways to eliminate barriers to trial participation. In rural areas where people may have limited access to resources, that can be an even more crucial part of staying patient-focused in a clinical trial.” Other times it may be about paying attention to the little things and responding — like including money in the trial budget for parking so the patient’s family member or friend is not circling the block instead of being with the patient while they have an appointment.

In the Outcome

Patients feeling better, living longer and achieving outcomes that matter to them is at the heart of patient-centric trials driving transformational advances and breakthroughs in cancer treatment. Following the death of his mother from cancer, Chairman and Founder Richard J Stephenson made a promise to change the face of cancer — founding the Cancer Treatment Centers of America® in 1988 and then Gateway for Cancer Research, a nonprofit organization, in 1991. “I never wanted to see another cancer patient suffer the agony of living without hope,” says Mr. Stephenson. For more than 25 years, in over 170 research trials, Gateway has been giving hope as it supports Phase I and Phase II clinical trials to improve treatment outcomes and restore the cancer patient’s quality of life.

Gateway’s rolling grant application process continually adds new trials to Gateway-funded research. Today Gateway supports 60 active trials in quality of life, advanced malignancies, blood, colorectal, kidney, skin, prostrate, breast, pancreatic, lung, cervical, head/neck, brain, bone, and osteosarcoma cancer research. Read more about developing patient-centric trials in the resources below.


“Patient centric approach for clinical trials: Current trend and new opportunities”
“Transforming Cancer Care: Patient-Centric, Personalized, Predictive”
“A Practical Overview of Patient-Centric Trials”
“Five Steps to Making Your Clinical Trials Patient-Centric”


“Patient centric approach for clinical trials: Current trend and new opportunities” by Neha Shankar Sharma

Perspectives in Clinical Research, July-September 2015

National Institutes of Health

U.S. National Library of Medicine

“Transforming Cancer Care: Patient-Centric, Personalized, Predictive"

Gateway Blog Post; October 4, 2016


“A Practical Overview of Patient-Centric Trials” by Hélène L. Svahnqvist, Anna Skabeev

Applied Clinical Trials; February 1, 2017; Volume 26, Issue 2


“Five Steps to Making Your Clinical Trials Patient-Centric” by Rosamund Round

Applied Clinical Trials; June 5, 2018



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