I believe a "mechanistic study" means a study where a medicinal product is being used but the purpose of the study is to investigate the patient or disease, not the medicinal product.

How does this differ from any other type of study? What is the purpose of this study? Why would we not be interested in the medicinal product?

Please provide a very simple example that a non-scientist could understand.


A mechanistic study aims to uncover a mechanism. It can be a mechanism of the disease (exactly how does the disease do damage to the body), or a mechanism of a drug (exactly how does the drug prevent or repair the damage) that is being investigated.

Understanding mechanism, be it mechanism of disease or mechanism of the drug, is very important toward targeted improvements of treatments, as opposed to trying lots and lots of compounds, hoping that someday we'll find one that's better.

Non-mechanistic studies involving drugs aim to show that the drug provides a clinically relevant health benefit over competing treatments, or to determine the safe dosage of a drug. At that point, the mechanism of action of a drug is known to a reasonably large extent.

In short, there are many different things that need to be known for drugs to reach the market. Mechanism is one of them.

  • 1
    $\begingroup$ "There are many different things that need to be known for drugs for each the market. Mechanism is one of them." This is incorrect according to the regulatory authorities I'm familiar with. The standard is safe and effective. Many drugs have been approved before we understood anything about their mechanism of action (e.g., Lithium). Some we still don't understand much about (e.g., Levetiracetam). $\endgroup$
    – De Novo
    Feb 25 '19 at 20:28

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