Risk-benefit analysis in clinical studies

According to GCP (ICH E6), Directive 2011/20/EC and AMG § 40, a clinical study must include a continuous evaluation of risk and benefit. The clinical trial may only be conducted in humans if the foreseeable risks and disadvantages for the trial subject / test person are acceptable in comparison to the anticipated benefit from the drug. In the evaluation of risk and benefit, only the individual proband / patient is considered - benefit or profit for society or even the sponsor are not evaluated.

All advances in diagnostics, treatment and prevention are seen as benefits, in particular improved efficacy, increased safety or optimised use (shorter treatment duration, lower dosage frequency, etc.) of the investigational product. In contrast, a risk is defined as any potential physical or psychological harm that may occur immediately or delayed. The analysis is performed with regard to the probability, extent, and duration of the expected damage. The assessment of risk always includes consideration of reversibility, avoidability, and consequences for the trial subject.

The risk-benefit analysis is carried out by the investigator as well as by the Ethics Committee and the higher federal authorities. Should it become apparent during a study that a previously unknown or underestimated risk exists or that the assumed benefit is less than assumed or does not exist at all, immediate action must be taken and the study must be stopped immediately if necessary. A violation of this law is a punishable offence according to AMG § 96.