According to Dorland's Medical Dictionary, a clinical trial is an experiment performed on human beings to evaluate the comparative efficacy of two or more therapies.
Clinical trials allow researchers to determine if a new drug or medical device is safe and effective for humans.
They are carried out only after laboratory studies (e.g., cell studies and animal studies) have suggested that the product appears to be safe and likely to work in people.
FOUR PHASES OF CLINICAL TRIALS
Regulatory agencies, such as the FDA, typically require a minimum of three phases to be conducted in clinical trials before a product can be approved for use. The goal for each phase is to test if:
The product is safe (phase I)
The product is effective (phase II)
The product is better than what is already available (phase III)
If the regulatory agency agrees that the trial results are positive, it will approve the drug or the medical device.
After a product is approved, the manufacturer will continue to monitor the product's effectiveness and safety (phase IV).
WHAT PRODUCTS NEED CLINICAL TRIALS?
All new drugs require clinical trials, but not all new medical devices require clinical trials.
MORE: Medical Devices (US Edition)
For instance, class I devices are exempt from clinical trials in the United States. However, they are mandatory for some class II and most class III devices. Additionally, most 510(k) applications do not require clinical trials, but most PMA applications do.
CLINICAL TRIAL PROTOCOLS
Clinical trial protocols are documents that describe the goals, design, methodology, statistical considerations, and other aspects related to the organization of clinical trials.
The main components of a clinical trial protocol are described in the ICH E6 Good Clinical Practice (GCP) Guideline.
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