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Organizational barriers to physician participation in cancer clinical trials
Carol P Somkin1, Andrea Altschuler, Lynn Ackerson
1Division of Research, Kaiser Permanente Northern California, Oakland, California 94612, USA. cps@dor.kaiser.org
Objective:
To assess barriers to physician participation in cancer clinical trials among oncologists, oncology leaders, and health plan leaders.
Study Design:
Mail survey of 221 oncologists combined with semistructured telephone interviews with oncology and plan leaders at 10 integrated healthcare systems.
Methods:
The survey instrument examined physicians' involvement in clinical trials; their perception of the value of trials to them, their patients, and their organization; and the presence of infrastructure support for trials and associated resource constraints. The interviews investigated similar issues from the leaders' perspective. We used linear regression to model trial enrollment and standard qualitative techniques to analyze the interviews.
Results:
Oncologists estimated they enrolled 7% of patients in trials. They expressed extremely favorable attitudes toward trials as a source of high-quality patient care and a benefit to themselves professionally. While positive attitudes toward trials were common, and were significant bivariate predictors of enrollment, organizational factors were the predominant predictors in multivariate analysis. The best combination of factors independently predicting enrollment related to organizational support for trials, subspecialty of the oncologist, and limitations of trial eligibility requirements.
Conclusions:
To increase trial participation, there is a critical need for infrastructure to support trials, especially additional support staff and research nurses. In addition, there is a need for better intra-organizational communication and consideration of the impact of trial design on internal health plan resources. This research supports the need to continue a national dialogue about the broadly defined benefits and costs of clinical trials to patients, physicians, and health plans.
Insights
Organizational support and trial design significantly impact cancer clinical trial enrollment. Improving infrastructure, communication, and eligibility criteria is crucial for increasing physician participation and patient access to novel therapies.
Area of Science:
- Oncology
- Clinical Research
- Healthcare Management
Background:
- Physician participation in cancer clinical trials is essential for advancing cancer care.
- Understanding barriers to trial enrollment is critical for improving patient access to innovative treatments.
Purpose of the Study:
- To identify barriers to physician participation in cancer clinical trials.
- To assess the perspectives of oncologists, oncology leaders, and health plan leaders on trial participation.
Main Methods:
- A mixed-methods approach combining a mail survey of 221 oncologists and semistructured telephone interviews with leaders from 10 healthcare systems.
- Quantitative analysis using linear regression to model trial enrollment and qualitative analysis of interview data.
Main Results:
- Oncologists reported enrolling 7% of patients in clinical trials.
- While physicians held positive attitudes towards trials, organizational factors such as support staff, research nurses, and trial eligibility criteria were the strongest predictors of enrollment.
- Subspecialty of the oncologist also influenced enrollment rates.
Conclusions:
- Enhancing infrastructure, including support staff and research nurses, is vital for increasing cancer clinical trial participation.
- Improved intra-organizational communication and consideration of trial design's impact on health plan resources are necessary.
- Continued dialogue on the benefits and costs of clinical trials for all stakeholders is supported.
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