Multi-Center Phase III Clinical Trials and NCI Cooperative Groups Workshop Summary (2009) / Chapter Skim
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Session 2: Barriers to Patient Recruitment and Physician Participation
Session 2: Barriers to Patient Recruitment and Physician Participation
Pages 41-64
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From page 41... ...
Every portion of the clinical trials program has to look at how they can eliminate the disincentives that they contribute to the process." 41
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In addition, the recent acceleration in the development of new cancer treatments and medical technologies demands more clinical trials, compounding the challenges that limit physician participation and patient recruitment. Beyond patient and provider attitudes, accrual is affected by strict eligibility criteria (George, 1996)
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As for the issue of what is preventing physician participation in clinical trials, Dr. Mendelsohn agreed with previous speakers' assessments that there is inadequate payment and frustration with excessive paperwork.
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The previous principal investigators said they resigned because the center director could not provide sufficient support for their research activities. The center has not reached the minimum number of patient accruals -- 50 patients -- that SWOG set for their clinical trials.
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Dr. Baker gave several suggestions for improving patient accrual to clinical trials, including eliminating unnecessary exclusions.
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Schilsky agreed: "When we look at the statistics on our U10 holders, all of whom are at major academic medical centers like SWOG, they account for essentially all of our committee leaders, and the majority of our protocol chairs and committee members, as well as provide a substantial fraction of our patient accruals." The second panelist, Dr. Gordon Bernard, professor in the Department of Medicine and assistant vice chancellor for research at the Vanderbilt University Medical Center, discussed some challenges faced in academic medical centers regarding physician participation and patient recruitment.
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Bernard discussed his viewpoint on the challenges facing academic medical centers with respect to physician participation and patient recruitment in cooperative group clinical trials. He has had clinical investigators ask him to direct institutional funding to make up the deficit for the cooperative group trials, but it was not possible to justify that these trials should be given priority over other clinical research.
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From page 48... ...
. This is the federal law that sets forth the minimal standards that must exist in any independent health plan; it currently does not require covering the routine care costs linked to clinical trials.
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"You have a paying customer who is not getting what is due," he said, "so it was really easy to get support for it from both Republicans and Democrats." He suggested fostering a grassroots effort by clinical trialists and patients to support the passage of the federal law. A workshop attendee noted that there are a number of cancer organizations, including ASCO, that have been working with Senators Edward Kennedy and Kay Bailey Hutchison on legislation that addresses coverage of routine care costs linked to cancer clinical trials as well as other cancer care concerns.
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"Of course a Phase I study explores a lot of safety issues and the like," he said, "but I do not think you would give it to somebody if you did not think it had a prayer of affecting the tumor size or whatever it is that you are measuring as your surrogate marker of disease." Academic recognition for clinical trialists The final panelist, Dr. Allen Lichter, executive vice president and chief executive officer of ASCO, addressed the pitfalls of career advancement for the clinical trialist.
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From page 51... ...
If you are not seeing patients and generating revenues, you are not going to have your salary supported. Many promotions committees flip to the grant page and look for grant funding in your name, yet grant funding in the name of the investigator is either lacking or is as a co-investigator." Another problem is that clinical trials can take years from conception to publication, "and in most academic medical centers today, the tenure clock is not calibrated to this time scale," Dr.
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Lichter noted, however, that this may not be practical to carry out. He also suggested that funding agencies should emphasize the important contributions made by clinical trialists, even when their work is funded indirectly.
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Dr. Curran pointed out that the NCI provides salary support for investigators who lead a Phase III trial, with the amount being determined by milestones such as finishing a protocol and other steps in a clinical trial process.
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Graham Cancer Center and principal investigator of the Delaware Christiana Care CCOP, discussing the contributions, benefits, and challenges of the CCOP program. CCOPs contribute one-third of the total patient accrual to NCI treatment and prevention trials, Dr.
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He also suggested developing more clinical trials for the majority patients for whom there is no appropriate protocol or who cannot participate in available protocols because of ineligibility. In addition, he suggested easing regulatory burdens and simplifying consent forms.
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This program includes a state cancer consortium, a statewide colorectal screening program with funding for the uninsured, and funding for uninsured patients for up to two years of cancer control, including cancer clinical trial activity. CCOP participation has also raised the cancer standard of care in the state, which has resulted in a significant drop in cancer mortality in Delaware.
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Dr. Feldmann then discussed the pressing issues that are limiting the participation of patients and physicians in cooperative group clinical trials, including reimbursement and funding issues, regulatory burdens, competition from industry trials, and problems with trial publicity.
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As had been previously mentioned, Dr. Feldmann noted that NCI funds are insufficient to address the financial insufficiencies faced by CCOP physicians, which increasingly rely on hospital partners to subsidize clinical trial costs or on industry trials revenues.
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The NCRN was established in 2001 with the goal of doubling patient participation in clinical trials within its first four years. It has exceeded this goal: within six years, patient accruals rose from 3 percent of the annual incidence of cancer to 13 percent.
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They typically follow clinician advice, even if the advice is to be randomized, and they infrequently seek multiple additional opinions. Another factor increasing patient and physician participation in clinical trials is the fact that in principle all extraneous standard health care costs linked to patients participating in clinical trials are automatically covered by the national health care system in the United Kingdom, although Dr.
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Dr. Kaplan added, however, that the NCRN may not be able to maintain its momentum in boosting patient accruals to cancer clinical trials in the face of the trials nearing full capacity and the economy starting to falter, which makes increased resources unlikely.
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She was critical of the informed consent process, noting that any procedure done in a hospital or clinic often requires patients to sign a consent form. From the patients' perspective, in order to receive the experimental therapy offered in a clinical trial they have to sign a consent form.
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Ms. Collyar suggested consulting patient advocates more often when determining study designs, consent forms, and other aspects of clinical trials.
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64 MULTI-CENTER PHASE III CLINICAL TRIALS and grandkids see." She recommended having futurists and systemsoriented experts involved in plans for improving the clinical trial system and called for building an action plan that is actually implemented. "We have to stop just talking about these issues and start taking action," she said.
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