What is the definition of a clinical trial?

The definition of a clinical trial is centered on the systematic investigation designed to assess the efficacy and safety of an investigational product, typically a drug or treatment. This process involves the collection of data from participants under strict protocols, with the aim of determining whether the product is effective compared to a control or placebo.

The focus on verifying efficacy highlights a core objective of clinical trials, which is to determine not just if the product produces an effect, but specifically if it does so in a consistent and measurable way that supports its use in medical practice. Clinical trials often follow a defined progression through various phases, each providing increasingly rigorous evidence regarding the product’s effects and potential risks.

In contrast, other options represent different concepts. A comparison of two different treatment protocols, while relevant in certain types of trials, does not fully capture the broader definition of what a clinical trial entails, as clinical trials can also include comparisons against a placebo or standard of care. Routine medical procedures do not involve the investigational aspect or the systematic collection of data inherent in clinical trials. Lastly, ensuring the safety of clinical sites pertains to good clinical practice and regulatory compliance, which, while important, is not a defining characteristic of what constitutes a clinical trial itself.