Will I Benefit From Participating In A Clinical Trial?
It is important for research volunteers to understand the general principles that apply to anyone taking part in the study:
- Participation is entirely voluntary;
- While you may or may not experience personal benefits as a result of taking part in the study, knowledge may be gained from your participation that may benefit others; and
- At any time, patients may decide to discontinue their participation without any negative consequences.
What Are The Costs Associated With Research?
Costs associated with research may vary. In some instances, additional testing or physician visits may be required. The cost of these extra tests may be covered by the study, although you or your insurance company may ultimately be responsible for the additional costs incurred. Information regarding this topic will be outlined in the research volunteer's Informed Consent Form. For more detailed information about costs associated with research please contact us (916) 851-2283
or by emailing us at [email protected]
What Are The Phases Of A Clinical Trial?
There are four phases of a typical clinical trial involving an investigational drug:
Phase I: In this phase, it is usually the first time a new treatment, drug or device is used in humans. The treatment under investigation is given to a small number of research volunteers at a very low dose or setting, and is increased over time according to the response. The purpose of this phase is to determine the best way to give the new treatment - either by mouth, injected into the blood or injected into the muscle - and how much of it can be given safely.
Phase II: Phase II helps to determine the effect of a research treatment on a particular disease or condition. Phase II trials involve the development of a protocol, or plan, about how the trial will be conducted and how the data will be analyzed. These plans are submitted to the Institutional Review Board (IRB), who must approve the protocol before the clinical trial begins. The IRB is a group of health professionals and non-medical persons whose job it is to review and monitor clinical research to protect the safety and rights of participants. Some research is also reviewed and monitored by federal agencies, such as the National Institutes of Health or the Food and Drug Administration. In a Phase II clinical trial, there may or may not be a control group. Control groups receive standard, current care. Treatment groups receive the experimental therapy.
Phase III: This phase compares the new treatment with the standard treatment on a larger group of research volunteers to determine effectiveness, dosing, and optimal characteristics of a treatment, drug or device. The same review and approval process takes place as in a Phase II clinical trial. In this phase, there is most likely a control group and a treatment group. Research volunteers are randomized, or assigned to a group based on chance.
Phase IV:This phase of research is conducted after approval has been given by the Food and Drug Administration. The purpose of a Phase IV clinical trial is to continue testing the study drug or treatment to collect information about its side effects in various populations and any side effects associated with long-term use.
What Is A Placebo?
A placebo is designed to resemble the treatment under investigation through a clinical trial. The exception is that the placebo is inactive. An example of a placebo is a pill containing an inactive substance
instead of the drug being studied. By giving one group of participants a placebo and the other group the active treatment, the researchers can compare how the two groups respond and get a truer picture of the active treatment's effects.
What Is A Protocol?
All clinical trials are based on a set of rules and action plan called a protocol. The study's principal investigator follows a protocol for the study. A protocol describes what is being studied (a new drug, new medical device, or new treatment), what types of patients may be eligible for the trial, the schedule of tests, procedures, medications and dosages, and the length of the study. While in a clinical trial, participants are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment.
What Is A Control Group?
A control group is the standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug, while the control group is given either a standard treatment, or standard treatment plus a placebo
Patient Video Resources
For informational videos on research and to learn more about clinical trials, Click here
to be redirected to the Office for Human Research Protection web page. There you will find a video series available in English and Spanish describing how research works, and what research is.