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About Clinical Trials
Why Volunteer?
As a volunteer in a clinical trial you are helping in the development of new therapies. Such therapies may offer better treatments and possibly cures for many acute and chronic illnesses. Although you may or may not benefit from your participation, others may indirectly benefit from your participation.
What happens during a clinical trial?
Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to either standard treatments or to no treatment if a present one does not exist.
Clinical trials are done to test the safety and effectiveness of new products. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all.
Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can give safely.
Phase 2 studies include more people than Phase 1 studies. Phase 2 studies include people who have the disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves on to Phase 3. In Phase 3 studies large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
What can I expect?
Every clinical trial is designed to answer certain research questions. A trial plan called a “protocol” maps out what study procedures will be done, by whom, and why. Products are often tested to see how they compare to standard treatment or to no treatment. The Food and Drug Administration (FDA) often provides extensive technical assistance to researchers conducting clinical trials by helping them design better trials that can characterize the effects of a new product more effectively, while at the same time reducing risks to those participating in the trials.
The clinical trial team includes doctors, nurses and other health care professionals. This team checks the health of the participants at the beginning of the trial and assesses whether they are eligible to participate. Those who are eligible and agree to participate are given specific instructions, monitored, and carefully assessed during the trial and after it’s completion.
What are the risks?
Some treatments being studied can have unpleasant or even serious side effects. Often these are temporary and subside when the treatment stops. Others, however, can be permanent. Some side effects can show up during the treatment while others may show after the treatment has ended. The risks depend on the treatment being studied and the participant’s state of health at the time of participation. All known risks will be fully explained by the study team before the trial begins. Study participants will be informed of new risk information as it becomes available.
What is Informed Consent?
The FDA requires that study participants are completely informed about the study. This process is known as “informed consent” and must be in writing. A consent form detailing the study objectives, the study plan, the risks and benefits is carefully reviewed with study participants by a member of the research team. This process provides an opportunity for the researcher and participant to exchange information and ask questions. The consent form must be signed by the participant prior to initiating any study related procedures.
The bottom line:
Although you may or may not benefit from your participation, others may directly benefit in the future from your participation. If you are unsure whether you want to participate in a clinical trial, take time and talk it over with family and friends. Know the risks associated and determine what level of risk you are willing to accept. Talk to your doctor or the research practitioner about the research protocol. Don’t be afraid to ask questions and always expect the best medical care when volunteering.
More Information:
FDA's Office of Special Health Issues
www.fda.gov/oashi/home.html
Centerwatch
www.centerwatch.com
Clinicaltrials.gov
www.clinicaltrials.gov
ElderCare Online's Medical Research Assistant
http://www.ec-online.net/Assistants/medresassistant.htm
As a volunteer in a clinical trial you are helping in the development of new therapies. Such therapies may offer better treatments and possibly cures for many acute and chronic illnesses. Although you may or may not benefit from your participation, others may indirectly benefit from your participation.
What happens during a clinical trial? Clinical trials are done to test whether new products are safe and work against disease. Study products are tested to see how they compare to either standard treatments or to no treatment if a present one does not exist.
Clinical trials are done to test the safety and effectiveness of new products. Many studies require that neither the patient nor the doctor know whether the patient is receiving the study treatment, the standard treatment, or a placebo (an inactive substance that looks like the drug being tested). In other words, some people may be getting no treatment at all.
Studies are done in phases to find different kinds of information. Usually, Phase 1 studies include only a few healthy people. Here, scientists find the best way to give a new treatment and how much they can give safely.
Phase 2 studies include more people than Phase 1 studies. Phase 2 studies include people who have the disease that the product is going to treat. Now scientists try to see how well the product works against the disease. If the product works, the study moves on to Phase 3. In Phase 3 studies large numbers of patients with the disease are included to see if the new treatment works as well as the standard treatment.
What can I expect?
Every clinical trial is designed to answer certain research questions. A trial plan called a “protocol” maps out what study procedures will be done, by whom, and why. Products are often tested to see how they compare to standard treatment or to no treatment. The Food and Drug Administration (FDA) often provides extensive technical assistance to researchers conducting clinical trials by helping them design better trials that can characterize the effects of a new product more effectively, while at the same time reducing risks to those participating in the trials.
The clinical trial team includes doctors, nurses and other health care professionals. This team checks the health of the participants at the beginning of the trial and assesses whether they are eligible to participate. Those who are eligible and agree to participate are given specific instructions, monitored, and carefully assessed during the trial and after it’s completion.
What are the risks?
Some treatments being studied can have unpleasant or even serious side effects. Often these are temporary and subside when the treatment stops. Others, however, can be permanent. Some side effects can show up during the treatment while others may show after the treatment has ended. The risks depend on the treatment being studied and the participant’s state of health at the time of participation. All known risks will be fully explained by the study team before the trial begins. Study participants will be informed of new risk information as it becomes available.
What is Informed Consent?
The FDA requires that study participants are completely informed about the study. This process is known as “informed consent” and must be in writing. A consent form detailing the study objectives, the study plan, the risks and benefits is carefully reviewed with study participants by a member of the research team. This process provides an opportunity for the researcher and participant to exchange information and ask questions. The consent form must be signed by the participant prior to initiating any study related procedures.
The bottom line: Although you may or may not benefit from your participation, others may directly benefit in the future from your participation. If you are unsure whether you want to participate in a clinical trial, take time and talk it over with family and friends. Know the risks associated and determine what level of risk you are willing to accept. Talk to your doctor or the research practitioner about the research protocol. Don’t be afraid to ask questions and always expect the best medical care when volunteering.
More Information:
FDA's Office of Special Health Issues
www.fda.gov/oashi/home.html
Centerwatch
www.centerwatch.com
Clinicaltrials.gov
www.clinicaltrials.gov
ElderCare Online's Medical Research Assistant
http://www.ec-online.net/Assistants/medresassistant.htm
