Fda policy clinical trials

Although "new" may imply "better," it is not known whether the potential medical treatment offers benefit to patients until clinical research on that treatment is complete.

Clinical trials are an integral part of new product discovery and development and are required by the Food and Drug Administration before a new product can be brought to the market. The preamble provides information about the regulation such as why the regulation is being proposed, the FDA's interpretation of the meaning and impact of the proposed regulation, and in those cases where the agency has solicited public comment, the agency's review and commentary on those comments. The preamble can also include an environmental impact assessment, an analysis of the cost impact, comments related to the Paperwork Reduction Act, and the effective date of the implementation or revocation as the case may be of the regulation.

Guidance documents listed below represent the agency's current thinking on the conduct of clinical trials, good clinical practice and human subject protection. Guidance documents are not binding for FDA or the public. Guidance should be viewed as recommendations unless specific regulatory or statutory requirements are cited. An alternative approach may be used if the approach satisfies the requirements of the applicable statute and regulations. Some links embedded within guidance documents may have changed since the document was published.

If a link does not work, please search for the document by title or contact FDA for assistance. Certificates of Confidentiality. Volunteers who participate in the study must agree to the rules and terms outlined in the protocol.

Similarly, researchers, doctors, and other health professionals who manage the clinical trials must follow strict rules set by the FDA. These rules make sure that those who agree to participate are treated as safely as possible. Learn more about the basics of clinical trial participation, read first hand experiences from actual clinical trial volunteers, and see explanations from researchers at the NIH Clinical Research Trials and You Web site.

Some people participate in clinical trials because none of the standard approved treatment options have worked, or they are unable to tolerate certain side effects.

Clinical trials provide another option when standard therapy has failed. Others participate in trials because they want to contribute to the advancement of medical knowledge.

All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions.

This helps to reduce the variation within the study and to ensure that the researchers will be able to answer the questions they plan to study. Therefore, not everyone who applies for a clinical trial will be accepted.

It is important to test drugs and medical products in the people they are meant to help.