Clinical Trial Results Reporting And Reviewing The Data

Once a clinical trial has completed phase 3, the researchers and sponsors responsible for the trial must report their findings and request approval from the appropriate agencies to sell the product.

Publishing Clinical Trial Results

Clinical trial results are typically published in a medical journal (such as the “New England Journal of Medicine,” among many others). The authors are often the scientists who developed the new treatment and analyzed the data to make conclusions about the new product.

Applying for Approval to Sell

In the United States, the Food and Drug Administration (FDA) must grant approval of a new drug or medical device. Other countries have their own agencies that perform an equivalent function.

If a company wants to sell a medical product in multiple countries, each country’s regulatory agency must approve it. This approval can be requested once phase 3 of the clinical trial has been completed.

In order to approve a new drug, the FDA requires that the requestor file a new drug application (NDA), a document that lists all the data from the clinical trial. For some clinical trials, this data may include pre-clinical experiments that were conducted in non-human systems.

A team of reviewers then evaluates the data and each reviewer writes up his recommendations about the product in question. Members of the FDA review these recommendations and decide whether or not to approve the new drug. In some cases, the FDA may ask the applicant to do further studies on the drug and then reapply.

If approval is granted, the clinical trial continues on to phase 4, also known as the post-marketing surveillance trial.

FDA Approval Criteria

When reviewing clinical trial data, the FDA and similar agencies are looking for the safety and efficacy of the new drug or device. The data must clearly demonstrate that the benefits outweigh any risks for patients.

Resources

CenterWatch. (2010). Overview of clinical trials. Retrieved December 12, 2010, from http://www.centerwatch.com/clinical-trials/overview.aspx

ClinicalTrials. (2007). Understanding clinical trials. Retrieved December 12, 2010, from http://clinicaltrials.gov/ct2/info/understand

U.S. Food and Drug Administration. (2010). The FDA’s drug review process: Ensuring drugs are safe and effective. Retrieved December 12, 2010, from http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm