“With great power, comes great responsibility” … as said by Peter Parker’s Uncle Ben in Spiderman
According to ICH GCP, the terms clinical trial and clinical study are synonymous (as per Section 1.12 of ICH E6(R2)). The terms ‘clinical study’ and ‘clinical trial’ are not the same:
“According to the FDA, an observational study is a non-interventional clinical study design that is not considered a clinical trial; and according to the EU Clinical Trials Regulation, a non-interventional study is a clinical study other than a clinical trial”
The impact of grouping them together is far reaching and deconstructive. According to Albert Einstein, the definition of insanity is doing the same thing over and over and expecting different results…I know from first-hand experience that we can submit the same study type to IRBs/RECs and competent authorities and get different results. Insanity? If the regulatory definitions are unclear or without regulatory context/ guidance, it’s just as difficult for the regulators to implement as for the researchers to understand.
Let’s keep things simple. Let’s get back to the first principles of regulatory compliance. In order for us to comply with the regulations we need to understand what we are being asked to comply with = Give us more meaningful and actionable definitions. Give us case-studies. A regulator that does this very well is the MHRA (I’m in the UK so I’m biased – just saying).
