Before agreeing to participate in a clinical trial, there are many things participants should know
Participants should be fully aware of all of the information provided in the research protocol, which typically includes:
•The purpose of the study
•The criteria for participation
•The study’s schedule
•The study’s length
•The information about the participant being studied
Participants should also understand how treatments used during the trial will affect any current treatments they are taking. They should always consult their personal physicians before agreeing to participate in a clinical trial. Most participants work with their health care providers and the trial’s research team collaboratively. Some patient volunteers may benefit from a drug being studied, but the research team does not provide complete healthcare.
The amount of information that participants require to make an educated decision about participation varies based on the type of clinical trial and the individual making the decision. Some questions participants should ask researchers include:
•What type of treatment will be involved in the study?
•What evidence is there that the new treatment could be effective?
•What other tests have been done involving this treatment?
•How do the test treatment’s risks compare with those of alternative treatments?
•What are the responsibilities for participation?
•What safety measures are in place?
•What happens if an injury occurs?
•What follow-up or long-term care is available?
•Can treatment be continued after the study if it is effective?
•Who is funding the study?
•Will results of the study be provided afterward?
Patients should understand what their options are if they were to become sick or their condition were to worsen during a clinical trial.
"Why Should I Participate in a Clinical Trial?"
Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease.
Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.
The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.
People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.
Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
Have you ever wondered...."what are the Study Coordinator and Doctor talking about" during your study visit?
It’s important for participants and prospective participants to understand certain terms and phrases associated with clinical trials.
All clinical trials are conducted in phases:
Phase I trials: involve a relatively small group of 20-80 people in order to evaluate safety and identify side effects of a new drug or treatment for the first time.
Phase II trials: involve a bigger group of 100-300 people in order further evaluate a drug’s safety and effectiveness.
Phase III trials: involve even more people, usually between 1,000-3,000, to confirm effectiveness, monitor side effects and compare with typical treatments.
Phase IV trials: also referred to as post-market monitoring, occurs after the FDA approves the drug or treatment and the organization monitors its use among the public.
A control group is a group of participants, usually half of all participants, that receives either no treatment or a standard treatment. Researchers compare a control group with a group receiving the experimental treatment in order to determine differences between the two groups.
A placebo is a drug or treatment that is harmless. It is given to the control group in a study without their knowledge. Usually, it is not used if a participant has an illness or condition that would be made worse if he or she went without some kind of treatment.
In order to further reduce bias, researchers conduct blind studies. In single blind studies, patients are not told which treatment they are given. In double-blind studies, neither the research team nor the participants know who is receiving which treatment. Typically, a third party, such as a pharmacist, will know who receives what treatment.
Randomization occurs when different treatments, including placebos, are assigned to participants at random without the knowledge of researchers or participants in order to reduce bias.
Once participants understand the study and understand the lingo used in clinical trials, they should evaluate the benefits and risks of participating.
Participants should be fully aware of all of the information provided in the research protocol, which typically includes:
•The purpose of the study
•The criteria for participation
•The study’s schedule
•The study’s length
•The information about the participant being studied
Participants should also understand how treatments used during the trial will affect any current treatments they are taking. They should always consult their personal physicians before agreeing to participate in a clinical trial. Most participants work with their health care providers and the trial’s research team collaboratively. Some patient volunteers may benefit from a drug being studied, but the research team does not provide complete healthcare.
The amount of information that participants require to make an educated decision about participation varies based on the type of clinical trial and the individual making the decision. Some questions participants should ask researchers include:
•What type of treatment will be involved in the study?
•What evidence is there that the new treatment could be effective?
•What other tests have been done involving this treatment?
•How do the test treatment’s risks compare with those of alternative treatments?
•What are the responsibilities for participation?
•What safety measures are in place?
•What happens if an injury occurs?
•What follow-up or long-term care is available?
•Can treatment be continued after the study if it is effective?
•Who is funding the study?
•Will results of the study be provided afterward?
Patients should understand what their options are if they were to become sick or their condition were to worsen during a clinical trial.
"Why Should I Participate in a Clinical Trial?"
Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease.
Treatments might be new drugs or new combinations of drugs, new surgical procedures or devices, or new ways to use existing treatments.
The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.
People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.
Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
Have you ever wondered...."what are the Study Coordinator and Doctor talking about" during your study visit?
It’s important for participants and prospective participants to understand certain terms and phrases associated with clinical trials.
All clinical trials are conducted in phases:
Phase I trials: involve a relatively small group of 20-80 people in order to evaluate safety and identify side effects of a new drug or treatment for the first time.
Phase II trials: involve a bigger group of 100-300 people in order further evaluate a drug’s safety and effectiveness.
Phase III trials: involve even more people, usually between 1,000-3,000, to confirm effectiveness, monitor side effects and compare with typical treatments.
Phase IV trials: also referred to as post-market monitoring, occurs after the FDA approves the drug or treatment and the organization monitors its use among the public.
A control group is a group of participants, usually half of all participants, that receives either no treatment or a standard treatment. Researchers compare a control group with a group receiving the experimental treatment in order to determine differences between the two groups.
A placebo is a drug or treatment that is harmless. It is given to the control group in a study without their knowledge. Usually, it is not used if a participant has an illness or condition that would be made worse if he or she went without some kind of treatment.
In order to further reduce bias, researchers conduct blind studies. In single blind studies, patients are not told which treatment they are given. In double-blind studies, neither the research team nor the participants know who is receiving which treatment. Typically, a third party, such as a pharmacist, will know who receives what treatment.
Randomization occurs when different treatments, including placebos, are assigned to participants at random without the knowledge of researchers or participants in order to reduce bias.
Once participants understand the study and understand the lingo used in clinical trials, they should evaluate the benefits and risks of participating.