Participating in a clinical trial
What are the benefits of participating in a clinical trial?
Clinical trials are intended to determine that new drugs are safe and effective. By participating in a a trial, people are given the opportunity to obtain treatments that may not be widely available for years. It is rewarding for many people to be an integral part of the drug development process. Volunteers are often provided financial compensation for their time and sometimes are provided with transportation, but financial compensation should not be the motivating factor for participating in a clinical study.
What are the risks of participating in a clinical trial?
All medications have side effects, which may vary from mild to severe.. Each product tested will have it's own unique treatment and side effect profile. Often times there is preexisting data from other studies that help determine what the individual risks are. The investigator can provide further details depending on the clinical trial.
How are participants protected?
The drug development process is strictly guided by the F ood and Drug Administration (FDA) in the United States, and Institutional Review Boards (IRB's), are fundamental in making sure there is strict adherence to ethical guidelines. All participants must review and sign an informed consent. All clinical trials are bound by international ethical guidelines and Good Clinical Practice is defined by the International Conferences on Harmonization (ICH) as: “A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity and confidentiality of trial subjects are protected.”
What is informed consent?
Informed consent is a process in which researchers provide potential and enrolled participants with information about a clinical study. This information helps people decide whether they want to enroll, or continue to participate, in the study. The informed consent process is intended to protect participants and should provide enough information for a person to understand the risks of, potential benefits of, and alternatives to the study. I
Phases of Clinical Research
Phase II
Phase III
Phase III
If a new treatment is found to be reasonably safe in phase I clinical trials, it can then be tested in a phase II clinical trial to find out if it works. The type of benefit or response the doctors look for depends on the goal of the treatment.
Phase III
Phase III
Phase III
This phase is designed to assess the effectiveness of the new intervention and, thereby, its value in clinical practice. Phase III studies are randomized controlled multicenter trials on large patient groups and are aimed at being the definitive assessment of how effective the drug is, in comparison with current 'gold standard' treatment
Phase IV
Phase III
Phase IV
A Phase IV trial is also known as postmarketing surveillance trial, or informally as a confirmatory trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold