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The Affordable Care Act (ACA) definitions of "routine costs," "qualified individual," and "approved clinical trial." AHRQ, Agency for Healthcare Research and Quality; CDC, Centers for Disease Control and Prevention; CMS, Centers for Medicare and Medicaid Services; DOD, Department of Defense; IND, investigational new drug No.; NIH, National Institute of Health; VA, Veteran's Administration. 1
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We applaud ASCO for undertaking this endeavor. As strong supporters of clinical research, we hope that all stakeholders take this opportunity to make improvements in oncology care that go beyond the basic requirements of the ACA. This is a tremendous opportunity to step back and realize it is a complex system that cares for a patient enrolled onto...
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Citations
... The volunteers suggested a work around to deposit a percentage of trial profits in a national or internationally held trust fund run by stakeholders including research participants where prospective participants could apply to meet unfunded participation and researchers could apply to this fund for help with meeting volunteer research expenses [33]. Previous participants might be granted priority access funding for them or a family member. ...
Background, Aims and Objectives:
Participants in health research want to be involved in the research. Researchers struggle with how to approach citizens as co-researchers, train them, tactfully reduce contributions that are less useful and what to do about compensation and where to include citizen input in a manuscript. The aim of this study was to use participatory action research to prioritize the research question and to explore projected solutions as citizens and researchers with equal voices in research. In the first section of this paper we provide an introductory explanation of Participatory Action. In the second section we discuss our findings.
Methods:
The research explored the strengths, weaknesses, opportunities and threats in clinical trials as represented through online communications. In this follow-up analysis we share learning points for successful research involvement. Researchers and citizens worked in a participatory research framework. They searched the Internet using keywords to locate social media conversations and Internet interviews about clinical trials over 4 months until a saturation point was reached. Data were de-identified and coded into a SWOT analysis and further coded into themes and analyzed. The findings and solutions were discussed using a circle chart for problem-solving. The data were prioritized by consensus and the process is reported here.
Results:
Investigators and participant researchers were not conflicted in assigning themes because the data were clearly stated and the same sentiments were repeated consistently. The teams reached consensus about which quotes to include to support the findings. These themes ranged from supportive researcher-to-participant and participant-peer relationships to experiences of shame, research disparity, intimidation and personal loss.
Conclusions:
This research engages citizen participants as equal partners in all aspects of this study. Public and patient involvement as co-production in research can be used to identify and suggest resolutions in research. The use of participatory action in research can improve consistency, communication, innovation and quality in clinical trials.
Background:
Accrual to cancer clinical trials is suboptimal. Few data exist regarding whether financial reimbursement might increase accruals.
Objective:
The objective of this study was to assess perceptions about reimbursement to overcome barriers to trial accrual.
Research design:
This was a cross-sectional survey.
Subjects:
Oncologists identified from the American Medical Association Physician Masterfile.
Measures:
We report descriptive statistics, associations of physician characteristics with perceptions of reimbursement, domains, and subthemes of free-text comments.
Results:
Respondents (n=1030) were mostly medical oncologists (59.4%), ages 35-54 (67%), and male (75%). Overall, 30% reported discussing trials with >25% of patients. Barriers perceived were administrative/regulatory, physician/staff time, and eligibility criteria. National Cancer Institute cooperative group participants and practice owners were more likely to endorse higher reimbursement. Respondents indicated targeted reimbursement would help improve infrastructure, but also noted potential ethical problems with reimbursement for discussion (40.7%) and accrual (85.9%). Free-text comments addressed reimbursement sources, recipients, and concerns about the real and apparent conflict of interest.
Conclusions:
Though concerns about a potential conflict of interest remain paramount and must be addressed in any new system of reimbursement, oncologists believe reimbursement to enhance infrastructure could help overcome barriers to trial accrual.
