NCI Director's Consumer Liaison Group Focuses on Improving Clinical Trials
The NCI Director's Consumer Liaison Group (DCLG), a federal advisory committee made up of advocate leaders who assist NCI in identifying nonscientific barriers to research and provide insight and advice on opportunities to collaborate and communicate with stakeholders, met September 21–23 in Washington, DC. The purpose of the meeting was to hear and discuss advocates' roles in NCI's efforts to modernize and improve the clinical trials process.The 16-member DCLG, which is overseen by NCI's Office of Advocacy Relations (OAR), heard presentations from researchers at NCI and elsewhere about how scientific advances in understanding cancer are changing the way clinical research is conducted. Topics included discoveries in genomics and immunology, new imaging technologies, development of drugs that target tumor pathways, co-development of targeted diagnostics and therapeutics, adaptive clinical trial design, and phase 0 trials.
Designing More Effective Clinical Trials
How a trial is designed can sometimes determine the success of the treatment being tested. By using discoveries from cancer genomics and cell metabolomics (the study of cellular chemical processes) to identify the subsets of patients who respond well to a novel therapy in phase II trials, and designing subsequent phase III trials to treat patients with similar genetic and metabolic profiles, results can become evident that would have been hidden in a broader population. This targeted approach allows smaller, more cost-efficient phase III trials that are more likely to show a benefit of a drug that is effective for a subset of patients with a particular molecular profile.
But there are barriers to using this approach, such as explaining this type of trial to newly diagnosed patients and recruiting the large number of potential trial participants necessary to find such specific patient subsets. DCLG Chair Gwen Darien, executive director of Survivor and Patient Advocacy Programs at the Samuel Waxman Cancer Research Foundation, led a group discussion about ways that the advocacy community can influence these and other critical issues to support improvements for more effective clinical trials.
Educating Institutional Review Boards
Another key challenge, highlighted by Dr. Lee Helman, director of clinical science at NCI's Center for Cancer Research, is the need to educate Institutional Review Boards (IRBs). IRBs, which are responsible for approving clinical trial designs at their institutions and medical centers, may not be up to date on the changing requirements for such research studies, he said, particularly the critical need to collect biospecimens from patients to identify genetic and other molecular data key to assessing a targeted cancer drug's effects.
"There is a need for advocates to contact and even serve on an IRB to educate its members from a patient's perspective on the relative risks and benefits" of new clinical trial technologies, suggested OAR Director Shannon Bell. DCLG member Cheryl Jernigan, an advocate and volunteer with Susan G. Komen for the Cure, suggested that advocates identify the national professional organizations that train and accredit IRB participants. Those organizations could partner with the advocacy community to educate IRB members about requirements for modern clinical trial design for cancer drugs.
DCLG members identified other key advocacy issues for clinical trials, including supporting insurance reimbursement for molecular screening of patients in research studies, educating providers and patients about the importance of genomics and biomarker data to determine who will benefit from targeted cancer drugs, and the need for researchers to address the growing problem of cancer patients with other health problems, such as obesity, which disqualify many patients from participating in clinical trials.
—Bill Robinson
NCI Cancer Bulletin October 4, 2011 - National Cancer Institute
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