Peritoneal Carcinomatosis Clinical Trial
Official title:
Evaluation of Ethical Implication of a Training Model Necessary to Gain Access to a Surgical Innovation Device.
- 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.
- 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.
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