Regulations

Unproven Interventions in Clinical Practice

37.       In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.

For more, please see the International Conference on Harmonisation (ICH) of technical requirements for registration of pharmaceuticals for human use and guidelines for Good Clinical Practice (GCP) at https://ichgcp.net/