What are the 4 Phases of FDA Clinical Trials?

Once a clinical trial is completed, researchers carefully examine all data collected before making a final determination as to the meaning of the findings or whether further testing may be needed. After phase 1 and phase 2 trials, researchers must decide whether to stop testing if it is determined that the new drug, device, or other treatment being tested is not safe or ineffective. After phase 3 trials, researchers reach conclusions about the medical importance of the new treatment approach for certain diseases or conditions. The purpose of a phase 2 clinical trial is to determine the correct dose and effectiveness in treating that particular disease.

Historically, phase II clinical programs have experienced the lowest success rate of the four phases of development. Researchers often use this type of trial to find out if they can reduce a person's risk of harm or death with early detection of the disease or condition. The protocol is designed to answer specific questions and to safeguard the health of participants in a clinical trial. Sponsorship and funding for clinical trials often comes from pharmaceutical companies that manufacture drugs, devices and other treatments.

In addition to those conducting clinical trials and government agencies that regulate trials, an Institutional Review Board (IRB) is established to review, monitor and approve biomedical research involving human subjects. At the end of Phase 1, results are collected, analyzed and submitted to the FDA for permission to proceed to Phase 2 Clinical Trials. Participants in clinical trials should be aware of these risks, as well as all the safeguards offered to them as human subjects of clinical research. Although phase 0 studies are conducted in humans, this type of study is not like the other phases of clinical trials.

While not mandatory in all cases, it is generally expected that there will be at least two successful phase III trials, demonstrating the safety and effectiveness of a drug, in order to obtain approval from appropriate regulatory agencies, such as the FDA (U.S. (USA) or the EMA (European Union). Whether the results of a clinical trial are particularly significant, they can be widely discussed among members of the media, at scientific meetings and by patient advocacy groups. The FDA is now tasked with ensuring that different groups are included and represented accordingly in clinical trials.

But FDA pharmacist David Banks cautioned against participating in clinical trials simply because of the potential for free treatments or other compensation. A publication focused on clinical research recently reported that, according to industry findings, nearly 90 percent of new drugs and treatments that reach clinical trials never reach FDA approval status. Phase I TrialsResearchers are testing an experimental drug or treatment for the first time in a small group of people. However, there are some circumstances in which clinical patients are used, such as patients who have terminal cancer or HIV, and the treatment is likely to make healthy people sick.

Bernice Gerchak
Bernice Gerchak

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