This topic is one which has been under discussion for some considerable time, but it seems we still have a way to go. The Clinical Trials Transformation Initiative (CTTI) recently published the results of a research project looking at GCP training for clinical trial investigators and the results are interesting, if not surprising. The paper entitled “More than a Box to Check: Research Sponsor and Clinical Investigator Perspectives on Making GCP Training Relevant” can be found here https://www.preprints.org/manuscript/202001.0209/v1
The researchers interviewed both sponsors and investigators to find out their views on GCP Training for site staff and also their recommendations and ideas for the future. I don’t want to regurgitate all of this information as they have presented it very well in the above paper, but I do want to highlight the most important messages and suggest some ways forward.
Essentially neither investigators nor sponsors seem to think that the current approach works very well. Investigators are fed up with having to complete the same training over and over, and sponsors are still not always confident that investigators really know GCP even after training. From my reading of the paper there are two key things we need for the future, one is relatively easy, but the first one I talk about below is more of a challenge.
Firstly it would make a huge difference if the global clinical research community could agree on a standard for GCP training for investigators which all sponsors would accept as a baseline requirement and would mutually recognise. Various groups have worked on this, but there is no one standard that seems to be accepted by everyone. Transcelerate’s GCP Mutual Recognition scheme is probably the best known https://transceleratebiopharmainc.com/gcp-training-attestation/ but this is based only on self attestation and from what I’ve seen and heard not many sponsors are recognising this as an acceptable standard. I realise this may be an impossible dream, but it would be great if we could come up with something that works! If anyone has any ideas how we could accomplish this I’d love to hear them.
The second key idea to come out of the research is the need to make GCP training more relevant, interesting and interactive. This one is a relatively easy fix. We need to focus investigator training on investigator responsibilities and use examples, quizzes and case studies to apply learning and help them to understand what it really means in practice. At its paper-based simplest we can create a few examples of Adverse Events and ask them to categorise them and say how they should be reported – more effective than a set of PowerPoint slides detailing the definitions and reporting timelines. Provide a scenario outlining a protocol or GCP deviation and ask them what action should be taken.
If we want to get more sophisticated we can use software to create simulations for them to work through, or interactive e-learning with activities to complete. One suggestion is to utilise just-in-time micro e-learning where short, interactive modules can be completed just before the investigator has to complete a GCP task, for example informed consent.
For me the title of the CTTI paper says it all – “more than a box to check”. This has been my plea for many years (and not just for investigator training!), surely with all the resources at our disposal now is the time to put this into practice?