What Should You Expect When Participating in a Clinical Research Study?
An intervention can be a drug, a device such as a pacemaker, a diagnostic tool, a genetic test, or even a new way to prevent disease or offer support for sick people. In some cases, clinical trials test new uses for existing medications. Clinical trials also test new therapeutic options for existing drugs – for example, once-a-week dose instead of a daily dose or an inhaled medication instead of an injection.
Researchers use clinical trials to find out whether an intervention is safe and/or effective. In addition, they are also investigating the possibility of existing drugs offering relief for other specific conditions for which the drugs may not currently be approved. Companies must show that new investigational medical products are both safe and effective before they can be approved. Clinical trials are the best way to test whether new investigational medications, practices, or devices are safe and effective.
If you are considering participation in a clinical research study, you may have some questions about what to expect.
Why should I participate in a clinical trial?
Two reasons: to help yourself and to help others.
It’s possible the treatment being tested will improve your health or your condition. You will certainly receive a very thorough evaluation of your condition, including many laboratory and other tests, and you will be given your diagnosis and an explanation of it.
In addition to potentially improving your health, you may also decide to participate in a clinical trial for the satisfaction that comes from being part of a scientific research study that may help others. Every day, there are people hoping for a breakthrough treatment that will make coping with their condition easier or cure it altogether. Clinical trial volunteers help make those discoveries available to people throughout the country and possibly around the world.
Is my participation confidential?
All information including medical, history of illness, personal and any information obtained during the study is confidential and protected by state and federal regulations governing clinical research. We will not release your personal information to anyone without you specifically authorizing us to do so.
Will I be compensated for participating in a clinical trial?
In nearly all of our trials, we will reimburse you a flat fee for your travel expense for each office visit. The reimbursement rate varies per study and will be discussed with you in detail on your visit to the office.
Who decides if I am eligible for a clinical trial?
Researchers must make two types of decisions about whom they study for a clinical trial, inclusion criteria and exclusion criteria.
Inclusion criteria are those characteristics that everyone must have to join the trial. For example, in a study of a medication for people with diabetes, all study participants need to have diabetes.
Exclusion criteria are those characteristics that people cannot have if they want to participate in the study. For instance, in a study of medication to prevent heart attacks, people who have already had a heart attack might be excluded.
How long do the studies last?
Each clinical trial is different.
Upon qualification into the study, this information would be provided to you.
How long does each office visit last?
The time for each visit can vary.
The initial visit is usually at least three hours because of the comprehensive and thoroughness of our initial assessment. Most visits after that are typically 45-60 minutes in duration.
Who will be diagnosing me or giving me medical advice?
We have an excellent staff with a wealth of experience, knowledge and familiarity in clinical research; however, only our board-certified doctors will provide you with medical assessment and advice.
What can I expect from the clinical trial team?
You can expect to be given a very thorough explanation about the clinical trial and to have all your questions answered by the study doctor and his staff.
You will be given an informed consent form to read and sign. This is required by law to make sure you understand what is involved in the trial. The consent form will include a discussion of the potential risks and benefits, and will have information about the schedule and duration of the trial, and the name of the study doctor whom you can call with questions or problems. You can also expect to have an evaluation of your condition and to be given the diagnosis by the study doctor.
Who decides what intervention I will get during a clinical trial?
Many clinical trials test a new investigational drug against a placebo, which looks just like the drug but doesn’t contain any active ingredients (like a sugar pill).
Other clinical trials test two different drugs to determine which is more effective. If it is a randomized trial, participants are randomly assigned by computer to the drug or the placebo. Because researchers have no say in the decision, the process is fair for everyone. However, randomization also means the researchers cannot guarantee what you will get if you enter the trial. Only the medication companies have this information in order to efficiently determine outcomes.
Some trials compare different drugs or different doses to learn which is most effective. The study participants are randomly assigned to one drug and do not know which medication they are taking.
What will it cost me to participate in a clinical trial?
All medical care, including tests and medications related to the clinical trial, is provided at no charge.
What happens if I want to leave a clinical trial?
You can leave a clinical trial at any time for any reason.
An important safeguard in a clinical trial is your freedom to leave. The informed consent document that you sign does not force you to remain in a trial. Clinical trials may offer you suggestions about how to leave the trial, particularly if the trial medication needs to be withdrawn gradually, but you have the final decision. If you leave a clinical trial, it may be helpful to let the researchers know why you are leaving, but this is not required. This information may help researchers improve the clinical trial process for other participants and may make the results of the trial more reliable.
What safeguards are in place to protect me?
By federal law, researchers must take several steps to make clinical trials as safe as possible.
- A written examination about the content of clinical research and ethical responsibility of the researchers.
- Preclinical studies that show that a new investigational treatment is safe and effective in laboratory animal tests.
- Use of strict protocol – an outline prepared before the beginning of a study that describes exactly what will take place during the trial.
- A written description of all the information that you will need to make an informed decision about joining a clinical trial. The process of giving you this information is called an informed consent.