Evaluation of Ethical Implication of a Training Model Necessary to Gain Access to a Surgical Innovation Device.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- qualitative analysis of the interviews
研究概览
简要总结
- The surgical device used to perform PIPAC procedure is commercialized by a single manufacturer under a monopoly regimen, and a formal training (economically supported by the manufacturer) is mandatory for surgeons who want to buy the device.Relations with the company and solutions to extend training require specific analysis from an ethical point of view.
- Based on the growing number of published papers from a growing number of international centers, the controlled training model is not limiting, and it is a successful model of development of this breakthrough innovation.
- But with the major involvement of the industry and the control of training, the different levels of interest could induce ethical questions.
详细描述
- Objective: Using the example of Pressurized Intra Peritoneal Aerosol Chemotherapy (PIPAC), the investigators analyze the development model of this procedure and provide an ethical analysis of the involvement of the industry in this development.
- Summary Background Data: In the case of breakthrough innovation, medical training is essential for safe use of the new procedure. Pharmaceutical companies may organize this training; but when it becomes the only training opportunity to use the device, scientists and clinicians are exposed to a conflict of interest.
- Methods: The investigators performed a literature review of PIPAC publications using the STROBE criteria. Then, the investigators conducted interviews with an expert panel to analyze the ethical impact of involvement of the industry in the development of the PIPAC procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •expert in pipac
- •more than 30 PIPAC per year
排除标准
- 未提供
结局指标
主要结局
qualitative analysis of the interviews
时间窗: 1 month
Questions for interviews were first prepared. Six questions for the clinicians and the scientist were elaborated about the interviewees' experience concerning the initiation and use of PIPAC, difficulties encountered to initiate this activity in their respective centres, description of the involvement of the industry for the development of the technique, the clinician-industry relationship, the mandatory nature of the training, and their ethical judgment on this model. For the biomedical manager, questions were about the set-up of the PIPAC procedure and the implication of the industry in the process. The commercial representative was interviewed about the business strategy of the industry. The interviewer had the freedom to adapt questions to prior answers. Interviewees did not receive the questionnaire before the discussion.
次要结局
未报告次要终点
研究者
Maillot Cédric
principal investigator
Centre de l'arthrose, Paris