NEWS

Cancer Advocacy Evolves as It Gains Seats on Research Panels

Caroline McNeil

In the early 1990s, breast cancer advocates like Deborah Collyar spent much of their time demanding attention. "We made a lot of noise," said Collyar, who is now president of Patient Advocates in Research, a national organization based in San Francisco. As one of the first cancer advocates, Collyar was also persistent. She called investigators, wrote letters, demanded audiences, attended meetings, and stood in line at the microphone when speakers invited questions.



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Deborah Collyar

 
What she and other activists were after was not just more funds for breast cancer research. They also wanted a voice in how those funds were spent: "We wanted to participate in the research dialogue," she said in a recent interview.

By the end of the decade, the advocacy movement had made definite progress in that direction. Advocates have won new seats on research planning and review groups, including the National Cancer Institute’s agenda-setting Progress Review Groups and the American Cancer Society’s grant application review committees.

In 1995, the Department of Defense cancer research programs began to include advocates as voting members of its review panels. The U.S. Food and Drug Administration brought advocates onto its cancer drug advisory committee in 1995 and made them voting members in 1998. In 2000, the Susan G. Komen Breast Cancer Research Foundation increased the number of advocates on its review panels from seven to 24 and started including advocate scores in the overall ratings of grant applications.

"Organizations are now reaching out to advocates as opposed to the advocates beating on the door," said Michael Katz of the International Myeloma Foundation. "There’s been an explosion of demand for advocates."

But that does not mean the challenges are over, according to advocates and researchers who met in September at NCI’s Cancer Advocates in Research workshop in Rockville, Md. In fact, one challenge stems directly from success. The movement has evolved, say leading advocates, to the point where it requires infrastructure—processes to guide and support lay people in the research organizations that are beginning to accept their presence.

"Now that we’re winning seats at the table, the question is how to use these seats to best advantage," said Yvonne Andejeski, M.D., program director of NCI’s Liaison Activities, whose office organized the workshop.

Defining Roles

One of the most pressing needs, according to both advocates and researchers, is to clarify the roles and responsibilities of advocates in research organizations. This theme emerged clearly at the workshop as well as in a series of interviews that NCI conducted in early 2000 with both advocates and researchers at the institute.

"Over and over again, we heard that there was confusion and concern about advocate roles," said Andejeski, who is leading the effort to create an infrastructure for advocate participation at NCI. Dubbed CARRA, for Consumer Advocates in Research and Related Activities, the new system is now taking shape, based on the surveys and on recommendations that emerged from the September workshop.

Much of the discussion at this meeting focused on the issue of roles: Should advocates try to evaluate the design of a clinical trial in a grant application? Are they expected to make judgments on the methodology of a proposed laboratory study? The answer from many advocates is that their principal role on research committees is not to assess the science directly—though some do—but to contribute a patient’s, family member’s, or research participant’s perspective.

That perspective can make a difference in several ways. It can, for instance, remind scientists that proposed research has to have relevance for cancer, said David Ringer, a program director at ACS. "Even though it’s great science, it may not have a clear path to an outcome relevant to cancer patients."

ACS asks its stakeholders, as it calls the patient advocates on its review panels, to ensure that a full discussion of cancer relevance is part of each grant review. This includes basic science studies, which, Ringer emphasized, can meet this standard as well as clinical studies.

The patient perspective can also influence a study’s design. Collyar told of a trial in which the investigators proposed that patients undergo endometrial biopsies every 3 months. "The advocates on the committee said that if they wanted to get patients to enroll in the study, it would be better to do biopsies less frequently," said Collyar.

Another classic example, said Ringer, was an epidemiologic study in which investigators planned to give a quality-of-life questionnaire to people who had just received a diagnosis of cancer. "Scientifically it made sense," said Ringer. "But the stakeholder said you’re not going to be able to do that; you won’t get reliable data. It took a cancer survivor to see the flaw in the design."

Not all review panels produce such defined instances of the patient perspective affecting outcome, but those who have participated say that the advocate’s presence makes small as well as big differences. "The fact that we’re there when a study is being discussed, rather than reacting to it after the fact, can make all the difference in the way a trial is designed," said Mary Lou Smith, another of the early breast cancer advocates. Once a part-time volunteer for the advocacy group Y-ME, Smith’s current job reflects the evolution of the movement: She is now director of patient, payer, and government affairs for the Coalition of National Cancer Cooperative Groups, based in Philadelphia.



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Mary Lou Smith

 
In the individual cooperative groups, advocates play different roles but are usually involved in protocol development and review and may be involved in priority setting. "We provide a sanity check," said Margaret Borwhat, a patient advocate in the Cancer and Leukemia Group B, one of the members of the Coalition.

Orientation and Training

How does a patient advocate contribute a lay perspective to a highly technical discussion? "A good grasp on the language and literature of science is important," said Sandra Zook-Fischler, a veteran advocate member of the FDA drug advisory committee.

Other advocates agree that it is important to understand research and the research process and that this is where a training and orientation process is needed. "Putting a non-scientist into a complex bureaucracy with no sense of role or task or expectation is a recipe for disaster," said Susan Weiner, Ph.D., vice chair for advocacy for the North American Brain Tumor Coalition.



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Dr. Susan Weiner

 
Several advocate training programs are under way or planned. The National Breast Cancer Coalition was the pioneer with its Project Lead, a 4-day course launched in the mid-1990s. The ACS started an on-site training program for its advocates in 1999. The Coalition of National Cancer Cooperative Groups is planning a program, DoD has a mentoring program for new advocates, and the Komen Foundation instituted a formal orientation process for its advocate reviewers in 2000. At the NCI, training and orientation will be an integral part of the new CARRA program, Andejeski said.

While the need to define roles and develop orientation processes is a high priority among research advocates, other processes also need attention, they say. One is the system by which advocates become involved in research activities. In the early days, when there were fewer advocates, involvement tended to be through informal arrangements that depended on who investigators already knew.

Now, organizations are beginning to develop systems to draw from the larger pool of advocates. The ACS, for instance, advertises "openings" through its local chapters and the media and puts all applications into a database. Program directors then select from among the nominees using established criteria. The DoD solicits nominations from several hundred advocacy organizations and makes selections, also based on established criteria.

Part of NCI’s plan for its CARRA program is to develop appropriate criteria for selection and establish a database of advocate participants, screened, trained, and willing to be matched up with appropriate activities at the institute.

Evaluation and feedback to refine the system is another evolving process in research organizations that have advocate participation. Follow-up interviews with both researchers and advocates are planned or an already established procedure in several places.

Like other parts of the infrastructure, evaluation processes are a sign of how established the advocates-in-research movement has become in the past decade and how its needs are changing as a result of success.

"Those of us who started this have to switch gears," said Collyar. "Now our challenge is to develop advocates who can dialogue effectively with researchers."



             
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