Understanding the clinical trial workflow

Clinical trials are needed for any type of new medical intervention on humans. This includes drugs, therapies, certain types of medical devices, and procedures. The trials follow a plan or a protocol that is defined by the investigator in a protocol document. Depending on the goals of the trial, a clinical trial might aim to compare the safety and efficacy of a product (such as a drug or a device) or a procedure (such as a new therapy) by comparing it against a standard product or a procedure. In some cases, participants are given a drug with no active ingredient, also known as a placebo, to compare them against participants who receive the new drug. This helps determine whether the drug is effective and is working as expected. For example, a new drug being studied to lower blood sugar is given to some participants who have high blood sugar. This is compared to another set of participants who are given a placebo. The observations from the two...