Not according to FDA and EMA regulatory definitions!
According to the FDA, an observational study is a non-interventional clinical study design that is not considered a clinical trial (as per Glossary of Framework for FDA’s Real-World Evidence Program – Dec 2018); and according to the EU Clinical Trials Regulation, a non-interventional study is a clinical study other than a clinical trial (as per Article 2.2(4) of Regulation EU/536/2014 – See Table below).
The terms ‘clinical study’ and ‘clinical trial’ are not the same. The impact of grouping them together is far reaching and deconstructive. It causes confusion at the study design, approvals/submissions, conduct, and reporting levels. According to Albert Einstein, the definition of insanity is doing the same thing over and over and expecting different results. As someone who provides regulatory guidance for clinical studies that are not clinical trials, 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 researcher to understand.
Take Home Point = The terms ‘Clinical Trial‘ and ‘Clinical Study‘ are not synonymous.