[Patient safety in clinical intervention research]. / Patiëntveiligheid bij klinisch interventieonderzoek.

ABSTRACT

In clinical intervention research, the monitoring of patient safety is essential. In December 2009, a symposium on the role of the different parties involved was organised. Research starts with a robust protocol with a section dealing with interim decision-making and procedures for reporting during the research. After the approval by an accredited Ethics Committee, the responsibility for the patient safety primarily lies with the investigators and sponsor (in the case of investigator-initiated research generally the Institutional Board of Directors). In addition, the appointment of a Data and Safety Monitoring Committee (DSMC) has become more frequent during recent years. This committee monitors the safety of patients by means of evaluation of interim results and advises the sponsor accordingly. The decision process concerning premature ending is a clinical decision, which should not exclusively be based on exceeding a statistical limit. The focus of the DSMC should be on safety issues; only in exceptional cases should a trial be discontinued because of clear efficacy, or the lack of it.