A National Cancer Clinical Trials System for the 21st Century Reinvigorating the NCI Cooperative Group Program (2010) / Chapter Skim
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4 Physician and Patient Participation in Cancer Clinical Trials
4 Physician and Patient Participation in Cancer Clinical Trials
Pages 191-234
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From page 191... ...
, the committee emphasized that the therapies offered through clinical trials should ideally be considered the preferred treatment choice for physicians and patients, if they are available. Broad participation in a publicly sponsored clinical trials system -- by investigators, community physicians, cancer centers, and patients -- will enhance the system's impact by efficiently providing practice-changing evidence.
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From page 192... ...
, but low rates of participation in cancer clinical trials remains a significant barrier to the efficient translation of scientific discoveries into advances in patient care. CLINICAL INvESTIGATOR PARTICIPATION Retaining a workforce competent in conducting clinical trials is essential to maintaining a strong publicly funded clinical trials infrastructure.
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Despite the importance of cancer clinical trials, the disincentives limiting provider participation are numerous. The American Cancer Society Cancer Action Network (ACS CAN)
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. For many cancer clinical trials, this amount appears to be inadequate to cover most labor costs, per subject enrollment costs, and additional research-related paperwork and reporting requirements (ACS CAN, 2009)
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Clinical investigators must contend with ambiguous and complex regulations in clinical trials, including the reporting requirements of the Food and Drug Administration (FDA) , in addition to those of the National Institutes of Health (NIH)
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. Participation by Community Physicians The majority of cancer patients are treated in community settings, whereas the majority of cancer patients who enroll in clinical trials are treated within academic settings (Cox and McGarry, 2003; Somkin et al., 2005)
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As mentioned above, a primary mechanism for improving community physician involvement in clinical trials includes better reimbursement for physicians enrolling patients in clinical trials. In addition, the committee emphasized the importance of recognizing the research staff who participate in cancer clinical trials, including physicians, nurses, clinical research associates, pharmacists, and others who conduct clinical trials.
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. For example, QOPI could use a metric to assess how many of a physician's patients are enrolled in clinical trials.
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Likewise, promotion committees may not have a sense of the time commitment required for clinical trial research or the importance of Cooperative Group research in advancing the field of oncology research and patient care. In addition, physician scientists are less likely than basic scientists to have protected paid time to perform their research (NCI, 2005a)
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6 The Cancer Centers Program is currently reviewing the CCSG guidelines and may not include a benchmark ratio in the next version, but it is not clear what it will be replaced with. Personal communication, Linda Weiss, National Cancer Institute, November 5, 2009.
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for up to 10 clinical investigators who play leadership roles in clinical trials at NCI-designated cancer centers. The intention of the award is to recognize clinical investigators who are not principal investigators on an NIH grant but who are actively involved in NCI-funded collaborative clinical trials, promoting collaborative team science and the retention of clinical investigators (NCI-TACF
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The committee recommends that all stakeholders, including academic medical centers, community practices, professional societies, and NCI, work to ensure that clinical investigators have adequate training and mentoring, paid protected research time, the necessary resources, and recognition. Physician Awareness of Clinical Trials A lack of physician awareness of clinical trials also limits trial participation.
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. In addition to perspectives about uncompensated time and effort associated with participation in a clinical trial, physicians may limit patient participation because of their own beliefs and assumptions about patient eligibility related to factors of age, comorbidities, cost, and adherence (EDICT, 2008)
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In addition to facilitating access to quality information about available clinical trials, it is also possible to limit overly stringent eligibility requirements for clinical trial participation. Participants in previous IOM workshop discussions suggested that overly stringent eligibility criteria unnecessarily inhibit patient accrual and may limit the applicability of the findings of clinical trials to the general population (IOM, 2009b)
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TrialCheck.org is a cancer clinical trials registry supported by the Coalition of Cancer Cooperative Groups. TrialCheck is updated daily and is the only clinical trials database integrated into an EMR system (Comis, 2007)
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. Such electronic tools with the right features for physician work flow could increase physician awareness about applicable clinical trials in real time.
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Using less restrictive eligibility criteria may make it more difficult to interpret clinical trial findings, attribute adverse events, and may require the collection of additional safety data. However, the adoption of less restrictive eligibility criteria for most studies would permit more rapid accrual and also allow broader generalizations to be made, could better mimic the conditions encountered in medical practice, and could reduce the complexity and costs of clinical trials without compromising patient safety or requiring major increases in sample size (George, 1996)
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encourage greater participation by patient advocates in the design of clinical trials and in patient recruitment for trials. One potential way to achieve greater participation by patients in the design of clinical trials is via community-based participatory research, in which community-based organizations or groups bring community members into the research process as partners to help design studies and disseminate the knowledge gained.8 Using their knowledge of the community to understand health problems and design trials that the community is likely 8 See http://www.ahrq.gov/about/cpbr/cbpr/cbpr1.htm.
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. In addition, the NCI Clinical Trials Monitoring Branch provides direct oversight of each Group's monitoring program, which requires on-site auditing as well.
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Therefore, the committee recommends that physicians strive to achieve the ASCO exemplary attributes for academic and community clinical trial sites, including high accrual rates of 10 percent or more. ExPANDING PATIENT ACCESS TO CLINICAL TRIALS Ensuring patient access to clinical trials is essential to improving and advancing high-quality, evidence-based care.
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. Patient Participation in Clinical Trials A variety of factors prevent robust patient participation in clinical trials (see Table 4-2)
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In a survey of American adults, 32 percent indicated that they would be very willing to participate in cancer clinical trials if they were asked to do so, and 38 percent of adults said that they are inclined to participate if they were asked but have some questions or reservations about participating (Comis, 2003)
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(IOM, 1999) Physician-patient communication is critical to improving clinical trial participation.
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Educational initiatives about clinical trials may facilitate understanding about clinical research and dispel misconceptions. For example, patients may incorrectly assume that cancer clinical trials often use placebos as a comparator, but the comparator is usu
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As indicated earlier in this chapter, a centralized, accessible, up-to-date registry could improve patient access to information about clinical trials and help patients locate the trials being conducted in their area. In addition, the committee recommends that CMS, federal and state health benefits plans, and private health insurers work with health care providers to educate patients more effectively about the availability, payment coverage, and value of clinical trials.
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. In January 2010, the major insurers of Florida, representing about 90 percent of Florida's group health insurance market, signed the Florida Clinical Trial Compact, agreeing to cover the costs of routine care for those participating in Phase II to IV cancer clinical trials that are approved by NIH, NCI, FDA, the Department of Defense, or accredited Florida medical schools and specialty hospitals (Colavecchio, 2010; Florida Clinical Trial Compact, 2010)
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organizations, and Medicaid New Jersey All insurers Routine patient care costs (1999) associated with all phases of cancer clinical trials.
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In March 2009, Senator Edward Kennedy and 21 cosponsors introduced the 21st Century Cancer Access to Life-Saving Early Detection, Research, and Treatment (ALERT) Act.9 Among other actions, the bill would amend ERISA to expand access to cancer clinical trials by requiring health plans governed by the requirements of ERISA to continue providing coverage for routine care, regardless of enrollment in a clinical trial.
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. Access to Cancer Clinical Trials Act of 2007, H.R.
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. Medicare began reimbursing routine care costs for beneficiaries enrolled in qualified clinical trials through a National Coverage Decision (NCD)
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. Third-Party Payment Policies and Clinical Trial Participation In 2009, the Agency for Healthcare Research and Quality (AHRQ)
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. Uncertainty over insurance coverage has the potential to decrease provider and patient participation in clinical trials.
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incentivize participation of patients and physicians in clinical trials, and (2) improve the prioritization, selection, support, and completion of cancer clinical trials.
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The many duties required of physicians and other key research staff, such as research nurses and clinical research associates, to participate in clinical trials are costly in terms of both time and resources. Even in cases where routine patient care in a clinical trial is covered by health insurers, the current payment policies do not reflect the additional time needed to enroll and follow patients in a trial.
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If cancer care is to be evidence-based and relevant to the diverse patient population, it is important for coverage policies to encourage rather than deter patient enrollment in trials. Therefore, the committee recommends that health care payment policies value the care provided to patients in clinical trials and adequately compensate that care.
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Congress should amend ERISA to prohibit health plans from denying (or from limiting or imposing additional conditions on) coverage for routine care associated with clinical trial participation.
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These circumstances can contribute to the underrepresentation in clinical trials of minority and underserved populations. Given the importance of trials in generating the evidence needed for making the best treatment decisions, more physicians should be encouraged to include trial participation in their clinical practice.
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2005. Clinical trials trickling away.
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2006. Enhancing Cancer Treatment Through Improved Understanding of the Critical Components, Economics, and Barriers of Cancer Clinical Trials.
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Bethesda, MD: Education Network to Advance Cancer Clinical Trials; Seattle, WA: Community Campus Partnerships for Health.
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1996. Reducing patient eligibility criteria in cancer clinical trials.
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2005. Patient and physician attitudes toward breast cancer clinical trials: Devel oping interventions based on understanding barriers.
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2005. Organizational barriers to physician participation in cancer clinical trials.
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2008. American Society of Clini Clini cal Oncology statement on minimum standards and exemplary attributes of clinical trial sites.
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