Running a clinical study is complicated.  From a regulatory compliance…perspective you need to know what type of study it is. This drives the direction of ‘what you need to do’ (regulatory compliance) versus what you ‘should’ do (best practice considerations).

As discussed previously, definitions, or more correctly ‘regulatory definitions’, are very important.  These definitions (e.g., non-interventional study) describe the boundaries of the study (what the study is and is not) and direct researchers to the applicable regulations and guidelines (hopefully).

When you intend to conduct of clinical study to answer a research question, it is important that you understand what the clinical study is.  Is it…(1) a clinical trial, (2) a non-interventional (drug) study, or (3) an observational study (e.g., natural history study)?

Why are these questions important?  Each of these three clinical study types are regulated differently…and to make matters worse…the regulatory framework for non-interventional (drug) studies and observational (disease) studies is different…in every country…globally.

For example, regulatory compliance considerations include:

[1] Clinical Trials = Clinical trial regulations + compliance with ICH GCP (very similar requirements globally)

[2] Non-Interventional Study = Local biomedical research regulations + pharmacovigilance requirements + consideration of/ compliance with best practices (e.g., ISPE GPP, ENCePP Guide on  Methodological Standards in Pharmacoepidemiology etc )

[3] Observational Study = Local biomedical research regulations

As you can see, the regulatory requirements for clinical trials are very different to those for non-interventional (drug) studies and observational (not drug) studies. Knowing what type of clinical study (regulatory classification) you intend to run is key to understanding what your regulatory obligations are, who you need to get approvals from, who you need to notify, what you need to notify…and what you need to tell patients so that they are adequately informed before they make the decision to participate in your research.

In summary, recognizing (correctly classifying) the study type is crucial for fulfilling regulatory obligations, obtaining necessary approvals, notifying relevant parties, and ensuring informed patient participation.