What should I know?
A clinical trial is designed to evaluate the effectiveness and safety of medications or medical devices by monitoring their effects on large groups of people. Clinical research trials may be conducted by government health agencies such as NIH, researchers affiliated with a hospital or university medical program, independent researchers, or private industry.
They represent an avenue for receiving potentially promising new therapies that would not otherwise be available and to determine that a proposed method to heal or alleviate a medical condition will pass strict standards for safety first, and then efficacy in clinical use.
Once a proposed therapy reaches the first step in human clinical trials- the “Phase I study”, it will have passed the Food and Drug Administration’s scrupulous requirements for safety and efficacy in animal models, but will not have been tested in humans.
Clinical trials go through phases. A Phase I Clinical Trial will look at the safety of the component introduced to the body, and that the method of administration is safe. For cell therapies the method of introduction will involve cell injection into or around the injured or diseased tissue or organ. The initial Phase I study will involve a few people- often around 20- and is designed only to test the safety of the proposed therapy. Some efficacy might be observed but that is not the focus of the Phase I trial.
Phase II trials continue to examine safety, in a larger group of patients, and will also start looking at efficacy - does the method do what it claims? The Phase II trial will include a control group- a group that does not receive the experimental treatment, receives a placebo (inactive substance) instead, or receives a tried-and-true therapy for comparison purposes, and will include a group of patients large enough to allow statistical analyses of outcome measures.
Phase III trials are the last round needed to show promise for the new method before the FDA will approve it for use in the common clinical setting. This phase will involve a large group of patients, a placebo control group, and often involve several different hospitals or treatment centers working together. In a “blinded study” the staff members administering the candidate therapy do not know if the treatment or the placebo has been given, and the patient will not know. Only the trial leaders keep careful records of what was given, to be revealed at the end of the trial. This is the fairest way to evaluate a therapy and to rule out “placebo effects” from patients who are expecting to feel better.
Clinical trials involve qualified candidates, usually people who are already under the care of a doctor or are recruited from a population in order to be trial participants. If you are considering taking part in a clinical trial, please remember the following:
To the left is a list of stem cell therapy and regenerative medicine clinical trials at UC Davis. If you do not find what you are looking for, you may place your key words here and click send. This will take you to the NIH-hosted site,
- Recruits are not generally allowed to determine what part of the study they will participate in. Some subjects may be in a control group, rather than receiving the intended therapeutic agent. While giving great hope, it is important to remember the primary purpose of a clinical trial is to demonstrate safety first, and then safety and efficacy.
- Likewise, would-be recruits who are not selected to be in a trial cannot change the criteria that would allow them to participate. Clinical trials details are all determined and vetted through the FDA. Changing the parameters after this process for any reason jeopardizes the research.
- Recruits should not be charged money for participating in a trial. FDA-approved clinical trials are funded by the Investigator’s institution, by a company, or by funding agencies such as the NIH or CIRM. Clinical trials sponsors are vetted through the UC Davis Internal Review Board (IRB) and proper US agencies.
- Please visit A Closer Look before considering any opportunity both within and outside the United States to understand the risks, responsibilities and possibilities of clinical trial research.
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