I read recently about a well known medical research charity which has joined forces with a couple of other well known charitable organisations to produce a new guideline for Good Clinical Practice for clinical trials which are not conducted in order to apply for a marketing authorisation.
This has caused two conflicting reactions in my mind. On the one hand I understand their concern that ICH GCP was originally written with the need for harmonisation of marketing authorisation requirements in mind, and does not therefore take the constraints of non-commercial research into account. When the Clinical Trials Directive first came into force in the EU there was a steep and painful learning curve for many non-commercial researchers who were now subject to GCP regulation in a way that had not been the expectation before. So I can see the view that new guidance to address some of these issues would be welcomed by many researchers, particularly those in countries where the infrastructure makes compliance with stringent requirements more difficult.
On the other hand I’m not sure that more, new, separate guidance is the answer. The move towards risk proportionate approaches for management and monitoring of clinical trials in ICH GCP as well as EU and US legislation allows for less stringent requirements for lower risk trials. Whilst I understand the constraints for non-commercial researchers I see no reason at all why non-commercial sponsors or investigators should be held to lower standards compared to their commercial counterparts. The principles of GCP should apply to all clinical research involving human subjects regardless of the context. Of course the way it works out in practice may be different, but the standards should be the same. Non-commercial researchers are, unfortunately, just as liable to commit scientific misconduct as their commercial colleagues and therefore need to be held to account. Subjects can be put at risk in non-commercial research and need protection. Errors and omissions in data collection and processing are just as likely in non-commercial research and so measures to ensure data quality are just as important.
My concern with developing new, separate guidance is that it will compound confusion and therefore ultimately increase risk to subject safety and data quality. Maybe I’m naïve, but would it not be better for those who are concerned about the appropriateness of the guidance to work alongside ICH and regulators in the continuing GCP renovation to clarify the distinctions between different types of clinical trials and the appropriate requirements for them in a coordinated effort?
I’d love to know what you think about this, please comment below and let me know.