Visual Universitätsmedizin Mainz

Management of conflicts of interest

 

The Department of Psychiatry and Psychotherapy of the University Medical Center Mainz has decided on guidelines for dealing with the pharmaceutical industry. These guidelines take into account the fact that the Department of Psychiatry and Psychotherapy, part of Mainz University Medical Center, is on the one hand interested in close scientific cooperation with the pharmaceutical industry in the investigation of new drugs, but on the other hand wants to achieve independence from the pharmaceutical industry with regard to prescribing and recommending drugs for the treatment of psychiatric disorders.

 

The guidelines formulated here integrate suggestions from other (international) groups and go beyond what the Association of Research-Based Pharmaceutical Companies (VfA) has formulated in its code of conduct. Collaboration with the pharmaceutical industry in clinical trials is being implemented in our "Center for Clinical Studies”, which we run together with the Interdisciplinary Center for Clinical Trials (IZKS) and the Clinics for Psychosomatic Medicine and Psychotherapy and Child and Adolescent Psychiatry and Psychotherapy.

 

The following describes the specific guidelines for the Department of Psychiatry and Psychotherapy of the University Medical Center Mainz:

  • Guidelines for Pharmaceutical Sales`Representatives (PSR) visits

  • Guidelines for funding of CME events

  • Guidelines for clinical drug trials


Guidelines for Pharmaceutical Sales`Representatives (PSR) visits

  • PSRs have no direct access to the doctors on the wards or in the ambulances

  • They only have access to the director of the clinic or senior physicians of the clinic if they want to discuss new clinical trials with them or if they want to report about new launches/indication extensions or relevant news on certain drugs

  • In the case of such news or new drug releases, the PSRs will report on the new drug or new indications at the doctor's conference. By doing so, on the one hand, all physicians are reached in an effective and time-saving way, and on the other hand, a critical discussion of the contents presented can ensure that the information is based on the criteria of evidence-based medicine and is integrated into the overall clinical and economic context

  • Any gifts, even small ones, such as pens, notepads or calendars will not be accepted.

  • Travel reimbursements for participation in CME events or scientific congresses are not accepted, but are reimbursed out of the training budget of the clinic or from independent third-party funds

  • Free drug samples will not be accepted



Guidelines for funding of CME events

  • CME events in the clinic take place without financial support from pharmaceutical companies

  • When selecting the speakers, care is taken that they have become known through critical and well-balanced presentations

  • All speakers must disclose COI at the beginning of their presentation

  • Travel expenses, accommodation and a reasonable fee for the speaker are paid out of the education and training budget of the clinic



Guidelines for clinical drug trials

  • All drug trials at the clinic are conducted at the Psychiatric Center for clinical trials (SPE)

  • The clinic only participates in studies financed by pharmaceutical companies if the tested drug can be expected to show a noticeable progress compared to substances already on the market

  • The clinic does not participate in observational studies. The exception may be large-scale Phase IV studies, which are based on a multicenter- and protocol design.

  • The clinic aims to intensify the implementation of publicly funded studies, so-called "investigator-initiated trials" (IITs). Examples can be found on the homepage of our study center