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Clinical Trials
The federal government of the United States has defined research as follows: “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to general knowledge.
A clinical trial (also clinical research) is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health. Interventional trials determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments. Observational trials address health issues in large groups of people or populations in natural settings.
Phases of Clinical Trials
Phase I The first of four phases of clinical trials, Phase I studies are designed to establish the effects of a new drug in humans. These studies are usually conducted on small populations of healthy humans to specifically determine a drug's toxicity, absorption, distribution and metabolism. Phase II After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed. Phase III The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling. Phase IV After a drug has been approved by the FDA, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events.
Risk to Human Subjects
Review committees, such as the UCI Institutional Review Board and the UCI GCRC Advisory Committee take into consideration the risk:benefit ratio when approving protocols for use of human subjects and center resources, respectively. The level of risk to the prospective research participant cannot, under any circumstances, outweigh the level of benefit to the participant and/or to generalizable knowledge.
When assessing risk, committees determine whether the level of risk exceeds that of “minimal risk”. The definition of minimal risk, as addressed in the Code of Federal Regulations means that “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” It is important to note that the Federal regulations define only “minimal risk.”
The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults.
Relevant Links
http://www.clinicaltrials.gov/ct/info/resources
http://www.centerwatch.com/patient/backgrnd.html
http://www.clinicaltrials.com/trials/patientsvc.asp
http://www.cc.nih.gov/ccc/prrc/healthyvols.html#healthy%20vols
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/45cfr46.htm
http://www.rgs.uci.edu/researchprotections/irb/index.htm
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