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Clinical Trials: Participant Information
« Thread started on: Sep 6th, 2006, 09:51am » |
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Clinical Trials: Participant Information
Part 1 of 4 Curtis A. thingyman, M.D.
Neurosurgeon
Barrow Neurological Institute of Phoenix, AZ
Phoenix, AZ, USA
http://www.spineuniverse.com/displayarticle.php/article2713.html?news=beta1
Ms. Mary Claire Walsh
SpineUniverse Staff Writer
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Clinical trials are a type of research study that uses human volunteers to see if certain medications or treatments are safe and effective. This type of research is an important tool researchers use to find ways to improve health and offer new treatment options for a wide variety of health conditions. While there are many ways in which clinical trial studies are designed, most are either interventional studies, in which a controlled environment is used to see if experimental treatments are safe and effective; or observational, in which natural settings are used to see how therapies or treatments affect large groups of people.
Most clinical trial studies are sponsored by pharmaceutical or biotechnology companies, medical institutions, and foundations. In some cases, a government agency such as the National Institutes of Health (NIH) provides funding for the trials. The United States Food and Drug Administration (FDA) oversees all clinical trial studies done in the U.S. It is responsible for determining if a clinical trial is needed, approves the scope and goals of the trial, helps select the researchers who will run the trial, review the results of the clinical trial, and determine if the new medication or device will be made available to the public.
Who can participate in a clinical trial?
In order for a clinical trial to produce reliable results, participants in the study must be carefully selected. All clinical trials have rules and guidelines about who can and cannot participate. These are called inclusion and exclusion criteria and involve such factors as age, gender, treatment history, stage of disease, and other medical conditions. Factors that allow a person to participate in a clinical trial are called the inclusion criteria and factors that do not allow a person to participate are called exclusion criteria. Some trials look for participants who are healthy and have no previous health conditions while other studies only want participants with certain illness to participate. Before a clinical trial can accept any participants, the sponsor of the study must clearly describe the inclusion and exclusion criteria.
What are the different types of clinical trials?
There are a variety of types of clinical trials including the following:
Treatment trials - test new treatments.
Prevention trials - look for new ways to keep people healthy or keep a disease from returning.
Diagnostic trials - look for better ways to diagnose a disease.
Screening trials - look for better ways to detect a disease.
Quality of life trials - look for better ways to improve the quality of life of people with chronic illnesses.
Each clinical trial is conducted in four phases. The FDA must approve each phase before the study can continue.
Phase I:
In this phase, a new drug or treatment is tested on a small group of healthy people to determine safe dosage, study how the drug works in the body, and see if it has any side effects. The overall safety of the drug is not known during this phase.
Phase II:
The drug or treatment can now be tested on a larger group of people to see if it is effective and to further test its overall safety. Rating scales are developed and used to record data during this phase.
Phase III:
Now the drug or treatment is ready to be tested on even larger numbers of people. The study will look even more closely at the drug's effectiveness, if it has any side effects, overall safety, and how it can improve a person's quality of life. Most drugs that reach this phase are considered for FDA approval.
Phase IV:
Once given FDA approval, the trial can enter into the final phase, which involves monitoring the drug after it has been released to the public. In this phase, researchers look for additional information such as risks, benefits, and optimal or additional uses of the drug. In some cases this phase is used to test the drug on a sub-group of people (such as patients over a certain age).
While clinical trials are an important (and sometimes the only) way to test a new medication or treatment, participants must be aware of the risks and benefits of the study.
Risks and Safety Measures
Participants must be aware that they may experience unpleasant, serious, or even life-threatening side effects of the drug or treatment being studied. They must also know that the treatment may not work, and that the requirements of the study may be more than they bargained for. Every clinical trial has a protocol, which is the plan on which the entire study is based. The protocol describes exactly what the participants must do during the trial such as how often they need to see the research staff, how much of the drug they need to take, what other procedures they must follow, and how long the trial will last. Sometimes, particularly for participants who are not in good health, these activities take up a good deal of time and attention.
To minimize risks, all clinical trials that involve human participants in the United States are approved and monitored by an Institutional Review Board (IRB). This is a group of doctors, researchers, community advocates, and others who ensure the ethical nature of the trial and make sure that the rights of the study participants are protected. The IRB also reviews all study-related documents such as the protocol, participant recruitment announcements, and consent forms.
Benefits
There are also many benefits to participating in a clinical trial. Not only does it give patients access to the latest research and treatments before they are available to anyone else, patients often are able to get expert medical care from leading health centers during the trial. Participation in a clinical trial also allows patients to become active participants in their own health care as well as help others by contributing to medical research. For many people, these benefits outweigh the potential risks of participation.
Clinical Trials: It's Your Choice
It's your personal choice if you want to participate in a clinical trial. If you are unsure, talk to your doctor, family, and friends. If you find a trial that you might qualify for, contact the research staff to get more information. Knowing as much as you can about the trial will make your decision a bit easier.
Depending on the type of study you are participating in, the clinical trial is conducted by a team that includes doctors, nurses, social workers, researchers, and other health care professionals. Once you have been given approval to participate, the trial will follow this general procedure:
You will be seen by the researchers before the trial to get your health history and assess your overall health.
You will be given specific instructions about how to participate (this is called the study protocol).
During the length of the trial you will be monitored. This may involve numerous doctor visits, tests, or other procedures.
Once the trial is completed, you will be able to stay in touch with the team for follow-up treatment information.
Important Questions To Ask About A Clinical Trial
If you are considering participating in a clinical trial, it's best to find out as much as you can about the study. To help you, here is a list of questions that you should consider:
What is the purpose of the study?
Who will be in the study?
Who is conducting the study?
Has the drug or treatment ever been tested before?
What does the protocol involve?
Will any part of my participation be painful? Require hospitalization? Affect my daily life?
Can I still participate if I'm on other medications?
What are the risks?
What if I need or want to drop out of the study?
How long with the trial last?
Do I have to pay for this treatment?
Do I get paid to participate in this study?
Do I need to talk to my insurance company before participating in this study?
How will I know if the treatment is working?
Can a friend or family member join with me?
What happens after the trial is over? Can I still get the treatment?
How do I find out about the results?
If you decide to participate in a clinical trial, be sure you are given a consent form. This is a document that clearly describes the nature of the study and outlines the requirements, risks, and benefits of participation. Read this document carefully before you sign it so you have all the information you need about your participation. Keep in mind that a consent form is not a contract and you can leave the study at any time.
For More Information
To find out about clinical trials, talk to your doctor to see if he or she is currently participating in any studies or knows of any that you would qualify for. Also, look at the links below this article for additional information about clinical trial opportunities. Finally, the National Institutes of Health has a website (http://www.clinicaltrials.gov/ct) dedicated to clinical trials and gives details about how to find out about the various trials currently being conducted.
It's your personal choice if you want to participate in a clinical trial. If you are unsure, talk to your doctor, family, and friends. If you find a trial that you might qualify for, contact the research staff to get more information. Knowing as much as you can about the trial will make your decision a bit easier.
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Re: Clinical Trials: Participant Information
« Reply #1 on: Sep 6th, 2006, 09:52am » |
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Clinical trial research is a complex and varied area of science. The following are some common terms you might see during your participation in a clinical trial.
Adverse Reaction - an unwanted effect of a drug.
Approved Drugs - drugs that have undergone and passed the vigorous FDA testing and approval process.
Baseline - the time during a clinical trial before a participant receives the drug or treatment being studied. Baseline measurements are then compared to measurements taken after the participant begins using the drug or treatment.
Blind - a clinical trial is called "blind" if participants are not told if they are receiving the actual treatment or a placebo.
Clinical Investigator - the researcher in charge of the clinical trial.
Clinical Trial - a type of research study that uses human volunteers to see if certain medications or treatments are safe and effective.
Confidentiality - in regards to clinical trials, this means that the personal identities and medical information of study participants remain confidential.
Contraindication - a circumstance in which the use of a drug or treatment should not be used.
Control Group - the group of study participants who receive a placebo instead of the drug or treatment being studied.
Diagnostic Trials - a type of clinical trial that looks for better way to diagnose a disease or condition.
Double-Blind Study - a type of study in which neither the participants nor the research staff knows who receives the drug and who receives the placebo.
Efficacy - the ability of a drug or treatment to produce positive results.
Experimental Drug - drugs that have not received FDA approval for a particular condition. If a drug is used to treat conditions other than what it was approved for, this is called "Off-label use".
FDA (Food and Drug Administration) - an agency of the U.S. Department of Health and Human Services responsible for making sure that all drugs, vaccines, and medical devices are safe and effective.
Inclusion/Exclusion Criteria - the guidelines or standards that determine whether or not a person qualifies to participate in a clinical trial.
Informed Consent - the process by which research staff explain the details of a clinical study to participants of a clinical trial.
Institutional Review Board (IRB) - a group of doctors, researchers, community advocates, and others who ensure the ethical nature of a clinical trial and make sure that the rights of the study participants are protected.
Open-Label Trial - a clinical trail in which both the research staff and the study participants know which drug or treatment is being studied.
Phase I Trials - the first step of a clinical trial in which a drug or treatment is tested on a small group of people to assess dosage, study how the drug works in the body, and see if it has any side effects.
Phase II Trials - the second step of a clinical trial in which the drug is tested on a larger group of people to see if it is effective and to further test its overall safety.
Phase III Trials - the third step of a clinical trial in which researchers look even more closely at the drug's effectiveness, if it has any side effects, its overall safety, and how it can improve a person's quality of life.
Phase IV Trials - the final step of a clinical trial that occurs after FDA approval. This phase involves monitoring the drug after it has been released to the public to see if there is any new information such as risks, benefits, or additional uses of the drug.
Placebo - a substance with no active ingredients and no treatment value. Used to compare with experimental drugs or treatments.
Prevention Trials - a type of clinical trial that looks for better ways to keep people healthy or keep a disease from returning.
Protocol - the plan on which the entire clinical trial is based. The protocol describes exactly what the participants must do during the trial such as how often they need to see the research staff, how much of the drug they need to take, what other procedures they must follow, and how long the trial will last.
Quality of Life Trials - a type of clinical trial that looks for better ways to improve the quality of life of people with chronic illnesses.
Randomized Trials - a study design in which participants are randomly assigned to one of the two or more groups being used to study the drug or treatment.
Screening Trials - a type of clinical trial that looks for better ways to detect a disease.
Side Effects - any undesired results of a drug or treatment.
Treatment Trials - a type of clinical trial that tests new drugs or treatments.
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