1. Eastman, Peggy

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The American Cancer Society Cancer Action Network (ACS CAN) has issued a new report that identifies barriers to enrolling cancer patients in clinical trials and makes specific recommendations on how to overcome them. ACS CAN is the society's advocacy arm.

American Cancer Soci... - Click to enlarge in new windowAmerican Cancer Society; clinical trials. American Cancer Society; clinical trials

"Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer: A Landscape Report" and the recommendations were released at the society's annual National Forum on the Future of Health Care, held at the National Press Club in Washington, D.C.


ACS CAN President Christopher W. Hansen said the report goes beyond simply identifying barriers because of its recommendations for taking action. "We'll be doing just that: taking action," he said. "This is an unprecedented time in the cancer fight," added Gary M. Reedy, CEO of ACS and ACS CAN. Reedy said it is important to take advantage of new laboratory discoveries and get new emergent therapies into clinical trials as soon as possible.


Reasons for Not Enrolling

While the oft-quoted figure of 3-5 percent for clinical trial participation may actually approach 8 percent, it is still too low, Reedy noted. Reedy said that about 20 percent of trials fail due to lack of accrual; however, he emphasized that cancer patients generally are not opposed to signing up for clinical trials. But, often patients simply don't know about them, he said. In fact, one of the biggest barriers is simply not being asked to enroll.


The genesis of the new ACS CAN initiative on clinical trials came about 2 years ago when President Obama issued the Cancer Moonshot challenge for the country, said Mark Fleury, PhD, a policy principal at ACS CAN who led the initiative for the new report and sat on the project's steering committee. "The community has long understood that there is a problem here," said Fleury, who serves on the steering committee of the Targeted Agent & Profiling Utilization Registry (TAPUR) study of ASCO.


Fleury said the report found the following statistics:


* 56 percent of patients will not have a local trial available for their cancer;


* 17 percent will be ineligible for a trial due to exclusion criteria;


* many eligible patients will not be asked by their health care provider to enroll; and


* only 27 percent of cancer patients will have the option to enroll in a local clinical trial.



Fleury said that more than 50 percent of eligible patients asked to enroll in a clinical trial will say yes; for every eligible cancer patient who says no, about 7-8 are never asked and given the opportunity to enroll. Those who are asked and decline cite the fear of side effects, loss of control, costs, and logistical aspects of participation as their primary reasons for not enrolling, according to the report.


In addition to low accrual, troubling racial, ethnic, socioeconomic, and age disparities exist in clinical trial enrollment, noted Fleury. For example, while cancers tend to be diseases of aging, older Americans are much less likely to be on clinical trials than younger patients, said Fleury. These disparities often prevent trials from yielding knowledge broad enough to represent the U.S. population as a whole.


Agreeing on the under-representation of minorities in trials was Lola A. Fashoyin-Aje, MD, MPH, Medical Officer of the Office of Oncology and Hematology Products of the FDA. She noted that the trend of dividing cancer clinical trials into smaller and smaller subgroups leads to a scarcity of data on minorities, older people and those in rural areas.


Overcoming Barriers

At the ACS CAN forum, panels of speakers, a number of whom were members of the new report's steering committee, addressed barriers to clinical trial enrollment and ways of overcoming them. "You really need to have dedicated in-house research staff" to increase trial enrollment, said Barbara G. Lubejko, RN, MS, an Oncology Clinical Specialist at the Oncology Nursing Society and a member of the new report's steering committee. She cited the need for the right staff, including clinical research nurses, to help guide patients through the enrollment process and answer their questions. In addition to the principal investigator, also needed are patient navigators, data managers, pharmacists, non-clinical regulatory managers, and budget/financial advisors, said Lubejko. She noted that often research staff have to fill two roles, a clinical role and a research role, and unfortunately in many settings the research role isn't valued as much as the clinical role.


Most physicians are interested in clinical trials, but there are a lot of competing demands on their time and they are pressured to be productive, said Jennie Crews, MD, MMM, FACP, Medical Director for the Seattle Cancer Care Alliance Network, Community Sites and Research Integration; Clinical Associate Professor of Medicine at the University of Washington; and Past- President of the Association of Community Cancer Centers. She noted that screening patients, matching them to clinical trials, and submitting data are very time-consuming, made more so by the fact that sponsors of trials have different formats for data. Within an institution, champions of research and a supportive culture for research are needed, she said, along with leveraging technology and centralizing the burdens of enrolling patients via clinical trial networks.


Evaluating the clinical trial portfolio at a particular center should be done at least yearly, said Janie Hofacker, RN, BSN, MS, Director of Programs for the Association of American Cancer Institutes and a member of the new report's steering committee. That way, trial staff can see what is doing well and what isn't, and whether in the following year more effort needs to be put into community-based institutions, for example.


"I have learned so much more about life from my patients and their families," said Richard Deming, MD, Chair of the Board of ACS CAN, Medical Director of Mercy Cancer Center in Des Moines, Iowa; and Chairman of the Oncology Service Line at Mercy Medical Center. He spoke in favor of clinical trial networks of community cancer centers, such as the NCI's National Community Oncology Research Program (NCORP). Deming noted that 85 percent of cancer patients are treated in the community, and community cancer centers that participate in clinical research are demonstrating a concern for advancing the profession of oncology.


Asked by Oncology Times if NCORP is an effective mechanism for involving community-based oncologists in clinical research, Deming said yes. However, he noted that there tends to be much better reimbursement for participating in industry-sponsored trials, so those physicians who participate in NCORP clinical trials do so "because it is the noble thing to do," and because they want to help advance the science.


In a panel on easing eligibility exclusions for cancer clinical trial participants, Jeffrey Allen, PhD, President and CEO of the Friends of Cancer Research and a member of the new ACS report's steering committee, said his organization has been actively examining how eligibility criteria can become more inclusive. He said that some in the field would prefer to keep clinical trial exclusions as they are, noting, "There's a reason that exclusion criteria have been established." But "things get stagnant and out of date" if they are not reexamined, stressed Allen. As an example, he cited excluding patients with AIDS from cancer clinical trials. Oftentimes these patients are leading normal lives and should be able to enroll in trials, he said.


In fact, ASCO's TAPUR study does not even mention HIV status or prior cancer in its trial eligibility criteria, said Suanna S. Bruinooge, MPH, Division Director of Research Strategy and Analysis, Center for Research and Analytics at ASCO and a member of the ACS report's steering committee. She said that if a patient has had a prior malignancy, it should be mentioned proactively-and may or may not constitute a criterion for clinical trial exclusion. "Patients often do have prior malignancies, particularly as they age," said Bruinooge.


With the explosion of novel immunotherapy agents, clinical trials are essential to bring these new treatments to patients, said Archie Tse, MD, PhD, Executive Director of Oncology Early Development for Merck and Co., Inc., and a member of the ACS report's steering committee. Calling immunotherapy "a game changer," Tse said this highly competitive field is yielding complex treatment regimens that must be carefully studied in trials. Like a number of other speakers, he stressed the importance of clinical trial networks.


"What is really encouraging to me is that we're talking about this from a systems standpoint," said Andrea Ferris, MBA, President and CEO of the LUNGevity Foundation and a member of the new ACS report's steering committee. Claire Saxton, MBA, Senior Director for Education & Outreach of the Cancer Support Community and a member of the report's steering committee, agreed that increasing cancer clinical trial enrollment is a systems problem, not simply a matter of more patient education. While more patient education is important, she said, "in some ways it's a patch for a systems problem."


To access the new report, go to https:///


Peggy Eastman is a contributing writer.


Recommendations to Promote Clinical Research

A number of groups in addition to ACS and ACS CAN have endorsed the new report's recommendations, including the Association of Community Cancer Centers, the Oncology Nursing Society, and the Friends of Cancer Research. Some of the key recommendations follow.


* A pool of diverse research-trained staff should be built and maintained, with special emphasis on developing a workforce reflective of underrepresented populations.


* Dual-role staff-clinical staff providing patient care along with fulfilling research roles-should receive incentives to promote their clinical research activities. Institutions should create protected time, a range of incentives, additional resources, and recognition to support dual-role staff in conducting clinical research.


* To achieve robust accrual, sites should employ protocols or technology to make the prescreening of incoming patients for trial eligibility more scalable and systematic.


* Awareness of clinical trials as a viable treatment option among cancer patients and their families should be promoted early during the course of patient care.


* Informed consent documents and processes should be improved to ensure education and comprehension by patients of the research in which they are contemplating participation.


* Coverage of the routine patient care costs of clinical trial participation must be ensured by all payers.


* Patients who participate in clinical trials should be shielded from out-of-pocket ancillary costs such as travel, parking and housing.


* Trials should be designed to be more patient-centric by including patient input during the design and implantation phases.


* Trial eligibility/inclusion/exclusion criteria should be modernized to achieve the most relevant parameters to ensure scientific integrity without unnecessarily excluding patients. It is especially important not to exclude a racial or demographic group.


* Since currently the demographics of participants in cancer clinical trials do not match the demographics of the U.S. cancer population, efforts are needed to ensure inclusion of patients who are older, are poor and are members of racial and ethnic minority groups.


* Clinical trial staff should seek engagement and partnerships with community-based leaders and organizations to broaden clinical trial enrollment, stressing the importance of clinical trial participation as a social justice issue.