During the last holidays I was thinking about what we do every day in clinical trials and how bureaucratic we are. ICH-GCP R3 clearly mentions that we need to have a risk-based, proportionate approach to the quality of the trial, in other words, when designing a trial we need to consider the risk associated with the IMP/medical device or trial intervention, but also the risk to the patient (confidentiality, well-being, safety, etc.) and the releasability of the data. Ok, nice words, but what?
It means that as soon as we start thinking about a trial, we should do a risk analysis, adapt the design to mitigate the risks, but also what data needs to be collected. Indeed you should ensure the quality of your data, so you need to avoid too much data collection, have a good eCRF etc. In fact, a risk-based proportionate approach also means that you should adapt your study design, your data collection tool, your document collection, your training requirements, etc. based on the risks you have identified. For example, if the IMP is already approved on the market, the drug accountability log can be replaced by the usual tracking in the hospital, idem, the training should only focus on what is not standard of care, so if the blood sampling is the same as usual, the nurse does not need to be trained, and so on. This also applies to the site delegation protocol. The idea is to reduce the burden on the site and the sponsor to what is essential, leaving room for interpretation of GCP. In fact, in the past, sponsors have interpreted it too strictly, resulting in a lot of unnecessary bureaucracy.
Next time I will explain what the role of the PM could be to ensure a risk-based proportionate approach!
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