NIS Considerations

Conquering the Complex Simplicity of Non-Interventional Studies

NIS Considerations

I’ve always talked about the ‘complex simplicity’ of non-interventional studies. NIS are, by design, simple. The challenge comes from the local regulatory differences that impact the classification categories, study start-up requirements and operational aspects of NIS. For studies that are so simple (by design) and so low risk (the patients are already taking the drugs), they can be challenging to run. But they don’t need to be…

NIS Classification
STEP #1 = Determine the High-Level Regulatory Classification for your Proposed Research (What is it?)

[1] Safe Baseline – All Countries Define and Regulate Clinical Trials

[2] Comfortable Starting Point – Start by Determining Whether your Study is a Clinical Trial

[3] Study Classification and Regulation – If it isn’t a Clinical Trial, then What is it and How is it Regulated?

The regulatory classification is important because it decides what regulatory pathways you need to comply with e.g., clinical trial (global), imposed post-authorisation safety study (Europe), non-interventional study of a new drug (India), postmarketing requirement (USA), AWB (Germany).

The following decision tree provides a generic overview of the classificatrion considerations for these types of studies.

STEP #2 = Determine the Local Regulatory Classification for your Proposed Research (What is it Locally?)

If we take India as an example, the approval requirements differ for non-interventional studies conducted with ‘New Drugs’ versus those conducted with ‘Old Drugs’.  Classification is based on risk and is explained in Rule 2(w) of the New Drugs and Clinical Trials Rules, 2019.  The English translation begins on page 147.  The Fifth schedule, which deals with the regulatory requirements for these studies, begins on page 228.

Refer to the  classification decision tree below…

STEP #3 = Determine the Local Regulatory Start-Up Requirements for your Study (What Do I Need to do?)

This example is for an observational study of a ‘New Drug’ in India…