In general, it takes six to seven year to complete a clinical trial. It can take up to 10 years for a new drug to be launched on the market. Animals must be used to test a drug before it can reach the stage of clinical trials. Adare Pharmaceuticals, for example, can only submit a treatment application to the Food and Drug Administration after the clinical trials have been completed. The FDA will review all results of the entire process and decide whether to approve the treatment.
The clinical trial phase of a drug’s journey from the lab to the market is the most time-consuming due to all the steps required to ensure its safety and effectiveness. Understanding what takes place during each phase will help you to understand why the process is so lengthy.
Phase 1
Typically, this phase of a trial involves between 20 and 80 healthy individuals who have the condition being studied. It is used to test the safety of new drugs, examining any side effects and answering questions about how the drug works in the body. It may also be examined to see if it’s effective.
Phase 2
Around 70 percent of new potential treatments go through this phase, which examines the effectiveness, investigates side effects and monitors safety. Researchers will administer the medication to large groups of participants with the same condition. This could be anywhere between several hundred and thousands of people. It is important to learn the best way to administer a drug candidate to maximize potential benefits while minimizing any risks. The Phase 2 phase can last from a few weeks to two years.
Phase 3
This phase is only reached by around 33 percent. It tests the effectiveness and safety of the therapy on the most participants. The study usually involves 300-3,000 participants who are from the patient population for whom the drug is intended to be used. It can last anywhere between one and four years. Participants will be randomly assigned to one of three control groups: a group receiving either a standard treatment or a placebo. In this phase, the studies are designed to determine if the drug candidate is effective and safe for the specific patient population. After this phase is complete, which may involve multiple trials, researchers will examine the results to determine if the drug candidate has an acceptable safety profile and is effective in treating a particular health condition.
If the drug is approved at the end of the phase, the pharmaceutical company will submit a New Drug Application or a Biologics License Application to the FDA. The FDA will then approve the drug and the company can begin marketing it.
