About Diabetes Research
What Is A Clinical Research Study?
A clinical research study is a scientific evaluation of the safety and exact effects of a new treatment (medication or medical device) when used by human subjects. Prior to testing in humans, the treatment is extensively tested in laboratory and animal studies.
A clinical research study may show that a new treatment is better than, as good as, or no better than the standard treatment for the same disease. Clinical research studies are also how treatments are found for diseases which previously didn't have a treatment.
Why Are Clinical Research Studies Necessary?
Researchers are constantly looking for better or new ways of treating diseases. Without clinical research the medications and/or medical devices available for treating all diseases would not change or improve.
Although much information is gained by laboratory and animal studies, new treatments must undergo controlled testing in human subjects because their safety and effectiveness may be different in humans and may differ from one person to the next.
The Food and Drug Administration (FDA) requires clinical research before it can approve a new treatment as safe and effective for public use. Clinical research is the only accurate way to discover how a treatment works in human subjects.
What Are The Different Phases Of Research?
There are four phases of clinical research. In Phase I studies, a new treatment is given to 20-100 healthy (not having the disease intended to be treated) people to discover the best way and amount to administer it without unacceptable side effects. Phase I studies also reveal information about how the body processes a new drug, how long the drug lasts in the body, and how the body eliminates the drug.
In Phase II studies, the new treatment is given for a relatively short time to several hundred human subjects who have the disease that the treatment is intended to treat. In Phase II studies, the treatment is being studied to determine if it actually has a beneficial effect on some marker of the disease in question. If Phase II studies do show that there is a benefit to using the treatment, it is then tested in Phase III studies.
In Phase III studies, the new treatment is compared to the standard treatment for the disease and is given to several hundred to several thousand human subjects for longer times. There are at least two groups of human subjects in Phase III studies, the treatment group (those who receive the new treatment) and the control group (those who receive the standard treatment or a placebo (inactive medication)).
In Phase IV studies, the new treatment is in the post-marketing phase. This phase is where they monitor for any safety issues and adverse effects of the drugs after they are approved and on the market.
Who Conducts Clinical Research Studies?
Pharmaceutical companies, research institutions, or other health care organizations may sponsor a clinical research study. The sponsor is responsible for applying to the Food and Drug Administration (FDA) to begin testing a new treatment in humans. The sponsor also funds the study and designs the protocol of the study in collaboration with the FDA. A protocol is a set of detailed guidelines that the investigators (research staff) follow in order to conduct the same clinical study at several different locations. Regardless of who the sponsor is, only trained doctors, nurses and research assistants actually run the study.
Who Is Eligible To Participate In Research?
Participation in a clinical research study is always voluntary. For each research study there are specific inclusion and exclusion criteria that must be met by every participant. The criteria that must be met are in place to protect the participant as well as to maintain the integrity of the research study. Some examples of inclusion criteria are: being within a specific age range, having a specific disease, and taking certain medications to treat that disease. Some examples of exclusion criteria are: pregnant women, persons with an allergy to the medication being studied, and persons with abnormal liver or kidney function.
What Are The Risks?
For every research study the risks are different. Most risks involve side effects or adverse reactions and are temporary. However, the fact that a treatment is still being studied makes it is impossible for every side effect and adverse reaction to be known. Some side effects and adverse reactions may be permanent. Before participating in a clinical research study, participants are informed of the known risks and during the study are monitored closely to decrease the risks.
There are a number of safeguards in place to protect participants. The Food and Drug Administration (FDA) regulates all clinical research studies and must approve the study after reviewing the study plans for safety. Also, any site doing clinical research has an Institutional Review Board (IRB), made up of doctors, other medical experts, and laypeople, which reviews the potential risks and potential benefits of the study.
What Are The Benefits?
There is a possibility that the treatment being studied will improve the participants health. Participants in clinical research studies receive a great deal of personal medical attention and free education about their disease and managing their disease. The treatment being studied is provided to participants free of charge. The examinations, laboratory tests, and other tests and procedures that are done during the study are also free and the results are shared with the participants and their doctors. Some clinical research studies offer financial reimbursement to participants for their time and reasonable travel and parking expenses.
Why Participate In A Research Study?
Some people participate in a clinical research study purely as a means of making a contribution to science. Others, because there is a possibility that the treatment being studied will improve their own or thier family members health. As a result of participating in clinical research, the information gained from each participant has the potential of improving the lives of millions.
Questions To Ask Before Agreeing To Participate In A Clinical Research Study
Potential participants should expect complete and honest information about the research study they are considering participating in. At the first visit to the research clinic, the informed consent form which explains the study in detail is read and all questions are answered. This is required by law to make sure that participants understand what is involved in the study. The following information should be obtained before consent is given:
- What is the purpose of the study? What is the treatment being studied supposed to do and how?
- Will all the participants receive the treatment or does the study involve the use of a placebo (inactive medication)?
- How long does the study last?
- How many visits to the research clinic will need to be made?
- What tests or procedures will be done and how?
- How long will each visit last?
- What are the possible risks and benefits?
- Are their other treatments available for the same condition?
- What happens in the event of an injury from the treatment or study procedures?
- Who should be contacted if further questions or problems arise?
Before participating in a clinical research study, potential participants are encouraged to discuss the study with their primary care physician.
Participants are free to stop participation at any time during a study.