Hot Topic Article from National Breast Cancer Coalition Advocacy Conference , 2007
Hot Topic Article
By Breast Cancer Advocate, Diane Chambers
June 1, 2007
Consumers in Peer Review
Similar to Girl Scouts who raise their hands and pledge aloud their promise to serve others, to make the world a better place, breast cancer advocates live up to an unspoken promise to ourselves and to our community. We promise to become knowledgeable as to the medical, physical, emotional, psychological, social, economical, and political aspects of breast cancer. And, we commit to use our knowledge to teach, help, and lead others in the fight to eradicate breast cancer.
When I became an advocate in 2003, I joined the National Breast Cancer Coalition and I applied to participate in Project LEAD, NBCC’s Leadership, Education, Advocacy and Development program. In Project LEAD we learned about the biology and genetics of breast cancer. We learned about the epidemiology, biostatistics, and the politics of cancer so that we can influence law makers on public policy and we can collaborate with scientists to implement new models of research.
Many LEAD graduates are using their knowledge and advocacy by serving on peer-review panels with scientists in the Department of Defense Breast Cancer Research Program. This program was created as a direct result of the National Breast Cancer Coalition’s “300 Million More” advocacy campaign to increase federal funding for research in1992. Since then influenced by continuing annual advocacy by the NBCC, Congress has been appropriating funding every year for this program which has proved to be highly successful. The reasons for its success are due to the combination of an efficient administrative structure, innovative research and the involvement of consumer advocates in its two-tiered, peer review process.
Though advocates are not scientists, as educated consumers, we bring a valuable perspective to the table that helps the scientists understand the human side of how newly- proposed research will affect consumers. Our knowledge and opinions combined with that of the scientists’ helps to ensure that the reviewing body makes appropriate funding decisions— toward scientific research that meets the needs and concerns of patients and the medical community.
At NBCC’s annual advocacy training conference this year, I attended a workshop for Project LEAD graduates, who like me, are aspiring to become peer reviewers. This workshop, titled “Consumers in Peer Review,” was led by three experienced breast cancer advocate- reviewers.
Sandi Walsh, who was our moderator, is a board member of NBCC, and president of California Breast Cancer Organizations. She has reviewed grants for the DOD BCRP and is an ad-hoc reviewer for the Integration Panel of the BCRP. This is the second level review panel who receives the proposals, from the scientific review panel, which has deemed them worthy of merit. The Integration Panel then compares them and decides which ones to fund. Rosemary Rosso and Karin Noss, our other two workshop leaders, have served on scientific review panels and are presently members of the DOD BCRP Integration Panel. They explained to us how advocates may become Consumer Reviewers, and using an actual research proposal as an example, led us through the review process.
“To become a reviewer, an advocate needs to apply,” Karin said. “You can go to the Department of Defense Website to find an application and the following list of requirements you must meet in order to be considered.”
§ Be a breast cancer survivor
§ Be an active participant in advocacy, outreach, or a support organization.
§ Have at least a high school education.
§ Read and write in English.
§ Have a desire to expand scientific knowledge.
§ Represent the views of your community.
§ Have internet access.
Usually, 2-3 consumer advocates are selected to serve on the panel with 12-20 scientists. If an advocate is chosen she receives approximately ten proposals, written by the Primary Investigators, which she must read and study. She scores each proposal on the following criteria, according to its relevance to consumers.
- Potential impact
- Research Strategy
- Personnel involved
- Environment in which the study will be conducted
When the advocate comes to the scheduled meeting with the panel, she is prepared to discuss her scores and her comments. During the meeting the members consider each other’s comments and scores. After deliberation, each member scores the proposal again. Karin and Rosemary said it is not uncommon for scientists to change their scores after hearing what the consumer advocates have to say. Because not all of the scientists on the panel are themselves experts on the proposal subject, the scientists are often on the same level of understanding as the advocates. The essence of the discussion is captured and summarized by a non-voting review administrator who sends the comments on to the second level reviewers, the Integration Panel.
The DOD IDEA Grant proposal we looked at during the workshop was titled, “Proximity Camera for Real-Time Intraoperative Cancer Cell Detection” in which the Primary Investigator wished to “develop an automated system that can detect benign versus malignant breast cancer cells from a limited sample source, such as from fine needle aspiration or surgical margins from partial mastectomy specimens, in a quick, efficient and accurate manner.”
The reason the Primary Investigator gave for the relevance of this research, is because of the current problem we have in determining at the time of surgery if the surgeon has obtained clear margins. The Primary Investigator explains:
The gold standard for achieving negative margins is to evaluate multiple intra-operative frozen sections of the excised tumor margin. However, the technique has many limitations. Technically, freezing the adipose tissue of the breast and making adequate and representative sections are difficult. Frozen section evaluations on multiple samples from a three dimensional cavity, while the patient and surgeon are waiting for the results in the operating room, are extremely labor intensive and time consuming. Also, performing multiple frozen sections on small lesions may compromise the specimens available for histological evaluation on permanent section. Pathologists have used touch preparations of the margins to limit the tissue utilized; this technique involves scraping cells off the edge of the specimen onto a slide to assess for the presence of tumor cells at the margin. However, the utility of this technique alone is limited by the pathologist’s expertise in cytologic interpretation and technical difficulties related to artifacts produced by the air drying process.
The PI believes that there is a strong need for a real time cancer detection system to detect negative margins more quickly and efficiently. She believes this will reduce emotional and physical distress for patients who now sometimes have to undergo a second operation, a delay in adjuvant treatment, and or an increased risk of wound infection. An added negative is the additional cost of multiple procedures.
In the rest of the proposal the PI outlines three different platforms of products and techniques she proposes to develop. She gives background information, and explains the methods she will use to develop and study these. She outlines how she will recruit patient participants, and how she will evaluate whether her assays can accurately distinguish benign versus malignant cells in breast aspiration samples.
First Rosemary and then Karin summarized the proposal for us according to how they understood what the PI was trying to do. “This PI proposes to come up with a new system using microarray technology to differentiate epithelial cells from malignant cells, using three different tests,” Rosemary said. “First, she will use a camera to detect normal versus malignant cells, put cells on a microchip treated with two different proteins, and then do an analysis to compare it with a standard analysis. Second, using a phenotypic array detector, instead of staining and looking at the size of cells, she will look at the proteins to see if they coincide with breast cancer and look for VEGF and HER2. Third, she will use confocal microscopy—microarray analysis to differentiate between the malignant versus normal cells, which is a more expensive test.
“Using mice,” Karin said, “She will take normal cell lines and mix them with cancer cell lines, and do these tests to see if they can differentiate between the benign versus malignant cells. Then she would use human cells for these tests with tumor cells.”
One comment Rosemary had on this proposal that was that this is a very early type of evaluation diagnostic tool on the entire continuum of care, and women will find out immediately the results as to clean margins. This is a definite plus for quality of life. On the down side, both Rosemary and Karin noted that microarray analysis is very expensive so they wondered if this test would really be an advantage. They added that these tests will be done at the time of surgery, and still more pathology analysis will need to be performed on the permanent section.
With regard to the six criterion both Rosemary and Karin agreed that this proposal is innovative regarding the use of new technology, to solve the problem with the current method of freezing which delays a quick analysis. The proposal also has high impact in that a new rapid test would increase quality of life for many women. As to the environment, they thought that the lab and the equipment the PI has available for her research iss adequate.
For the research strategy, Rosemary thought that this new test would require a new level of expertise on the part of those performing and reading the tests. She also thought that the PI should be evaluating the new test along with the old tests to see if this new way will be better, but this was not mentioned in the proposal. Karin had some concern about the second test looking at estrogen which she thought would skew the results. “There is little discussion here as to what the researchers expect to happen,” she said.
As for the personnel who would conduct the research, Rosemary questioned whether they had a background in breast cancer and if that would help them interpret their findings.
“The goal of any research is to hopefully discover newer, better, and cheaper therapies,” Karin said. “As advocates, things we consider as to whether the research has high impact or merit are if it has the potential of reducing recurrence, increasing survival, reducing further surgeries, or may perhaps be of significant importance in helping others who have a different form of cancer.”
“Another thing to evaluate, Rosemary pointed out, “is whether it will potentially bring forth something better in terms of cost, treatment, survival, or reduced side effects.”
All things consideration from an educated advocate’s perspective can assist in weeding out valuable research from the frivolous or trivial, speed up and advance our knowledge in the treatment of breast cancer, and further us toward the eradication of this disease.
Serving on a scientific review panel is a big commitment, requiring intellectual effort and dedication. The benefits, besides a personal gratification in being a part of something important and of value to society are: a standard honorarium and expenses paid to the meetings in Washington D.C. Exciting too, is when the research results are reported back to the American people at a public meeting held every two years called the ERA of Hope.
The next Era of Hope will be held this year in October, where hundreds of scientists, clinicians, epidemiologists, mathematicians, chemists, physicists, cancer survivors, and advocates will come together to celebrate their advances, share ideas, and set new goals.
book by Diane Lane Chambers
Hearing the Stream, A Survivor's Journey into the Sisterhood of Breast Cancer
Diane Lane Chambers