Participation in cancer clinical trials provides patients access to the latest, most promising investigational interventions, as well as close monitoring of care.
However, only 3% to 5% of eligible adult cancer patients are enrolled in clinical trials. This results in delays in the progress of cancer research, as well as increased costs for improving and disseminating effective cancer treatments. The reasons for low rates of clinical trial participation are numerous. Trials may not be available to those willing to participate; when they are available, patients are often excluded because they do not meet trial eligibility criteria.[2-4] In the United States, available data on the demographics of oncology patients participating in clinical trials show that those who do enroll are more likely to be younger, male, and Caucasian, and to have later-stage cancer, compared with those not enrolled in trials.[5-8] These trends are also true of clinical trials conducted in other countries.
Cancer-related clinical research and clinical trials have traditionally been conducted at well-established academic medical centers, while 85% of cancer patients are diagnosed and treated at local, community-based clinical practices. Therefore, community-based cancer research is critical in advancing cancer care for the large, diverse patient population that receives treatment in a variety of local healthcare delivery settings. In addition, participation of community oncologists and primary care physicians in cancer prevention, control, and treatment trials significantly helps facilitate the translation of research advances into practice.
Support for Community-Based Research
Community Clinical Oncology Program (CCOP)
For the last 4 decades, the National Cancer Institute (NCI) has acknowledged the importance of community-based oncology research through several initiatives and programs for community practices. Historically, the significance of community-based research was solidified in 1982, when the NCI initiated the CCOP. This collaborative partnership between research institutions and community-based physicians helped to facilitate phase III cancer prevention, control, and treatment trials in the community-based practice setting. The CCOP was designed to disseminate and implement advances in cancer care by linking cancer investigators and academic centers to community-based practices, thus expanding access to clinical trials and promoting cancer treatment innovations within the community populations that otherwise might not have had access.
NCI Community Cancer Centers Program (NCCCP)
Despite these efforts, community-based cancer research continued to face challenges as a result of the era of emerging science, technology, genomics, and molecular-targeted therapy, as well as a rapidly changing healthcare environment. In 2007, the NCI further expanded its community-targeted efforts by launching the NCCCP, a public–private partnership with 21 community hospitals in 16 states. The goals of the NCCCP were to enhance access to and improve the quality of cancer care by expanding the infrastructure to support a platform for basic, clinical, and population-based research, as well as informatics, biospecimen collection, and cancer care disparities in community hospitals. Self-reported data collected at NCCCP sites between 2007 and 2010, supplemented with data from the NCI Cancer Therapy Evaluation Program, showed that the availability of phase III trials and patient accrual increased by 16% and 133%, respectively, at NCCCP sites, compared with 8% and 30% nationally. In addition, enrollment of racial and ethnic minorities in oncology trials increased by 82%, from 83 to 151 patients; the accrual of patients aged 65 years or older in oncology trials also rose by 221%, from 200 to 641 patients. The exact changes in trial portfolios and accrual differed by sophistication of the site and by prior experience conducting clinical trials at the site.
NCI Community Oncology Research Program (NCORP)
In 2014, the NCI initiated a new community-based program, the NCORP, to align with and replace the CCOP and NCCCP programs. The goals of the NCORP are to support clinical trials on cancer control, prevention, treatment, and screening in the community setting, as well as to expand the scope of research to include cancer care delivery. The NCORP initiative emerged around the same time as two other significant changes: 1) the transformation and condensing of nine longstanding NCI Cooperative Group programs into four new groups under the National Clinical Trials Network, and 2) the implementation of the NCI Central Institutional Review Board. Both of these changes helped to provide easier access to all NCI Cooperative Group clinical trials with some reduced regulatory burden. In a study conducted at St. Francis Cancer Treatment Center in Grand Island, Nebraska, we found that participation in both NCI programs, NCCCP and NCORP, positively impacted clinical trial–related activities and expanded research, with enhanced access to quality cancer care. In addition, NCORP provided a robust Cooperative Group trial linkage, resulting in a record-high clinical trial portfolio.
Barriers to Participation
Funding is one of the largest challenges facing Cooperative Group clinical trials. Namely, there has been a growing discrepancy between the actual cost of Cooperative Group trials compared with the amount of funding received from the NCI. In addition, the routine per-case reimbursement for Cooperative Group trials has remained stagnant at around $2,000, despite an increase seen in the actual cost over time to approximately $6,000. In a 2010 American Society of Clinical Oncology (ASCO) survey of 500 clinical trial sites, 33% indicated that they planned to limit their involvement in Cooperative Group trials, and 75% cited inadequate funding as a reason for doing so. To address these concerns, the NCORP intends to award $74.5 million of funding in fiscal year 2019 to be used for up to seven 6-year research projects. While application budgets are unlimited, the focus should reflect the needs of diverse patients in a variety of community oncology settings, including rigorous studies on cancer prevention, control, screening, care delivery, and quality of life.
As strong and, to some extent, as successful as these NCI programs have been, the national clinical trial participation rate of 3% to 5% remains unchanged, with mounting barriers to enrollment. In addition to regulatory and bureaucratic requirements, administrative, financial, and organizational challenges beyond the control of participating hospitals and clinicians impede clinical trial participation nationally. Barriers to clinical trial participation have also been classified as structural, clinical, and attitudinal, with some differentiation according to demographic and socioeconomic factors.
In an era of increasing emphasis on shared decision making, the opportunity for patients to choose to participate in a clinical trial would be of great significance.[18,19] However, several disparities exist between trials in oncology vs other medical specialties. Hirsch et al reported on the 40,970 studies registered with ClinicalTrials.gov and found that oncology trials comprise 21.8% of all trials, followed by trials focusing on mental health (9.0%), infectious disease (8.3%), diabetes mellitus (6.1%), and cardiology (5.7%). Oncology studies were significantly more likely to be single-arm, open-label, and non-randomized. In addition, oncology trials were smaller compared with other specialties, with a median patient accrual of 51 vs 72 in other disease states. Early-phase trials were also more common in oncology. Further comparisons between trials in oncology vs other medical specialties have found that oncology trials are more likely to have ongoing recruitment and are less likely to report completion of trials.
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