What is a clinical trial?
A clinical trial is a research study involving volunteer participants to assess the safety and effectiveness of trial medication and/or new treatment techniques. A clinical trial is used to help the Food and Drug Administration (FDA) determine whether or not the trial treatment or medication being studied is safe and effective at treating a particular diagnosis and should be approved for use by the general public.
What kind of research do you do?
Clinical trials are conducted in four phases with each phase focused on a different purpose. Phase II and III clinical trials are “intent to treat” trials in which the investigational medication is provided to a large group of participants to ensure it is safe and effective in treating a specific diagnosis.
These types of clinical trials require participants with a certain health condition who may or may not be taking medication. You can be on medication and have a diagnosis to participate in our trials. In fact, that is what may qualify you to participate.
Phase IV clinical trials are “aftermarket” trials. The medication provided in these clinical trials has already been approved by the FDA.
A Phase IV study may be conducted:
- To gain additional information about the medication and its effects, risks, benefits, and optimal use, or
- To compare a medication to another currently marketed medication for advertising and sales purposes.
Will I get paid to participate?
The most valuable benefits of participating in a clinical trial are the potential for treatment or medication for your health condition and the one-on-one medical care, both of which you would receive absolutely free of charge and with no involvement of your health insurance. Depending on the length of your trial, these benefits can add up to thousands of dollars. You also have the benefit of feeling good about participating in research that could benefit future generations.
In addition to free medication, many of our clinical trials also offer monetary stipends for each clinic visit completed during the course of your trial. Some trials also include provisions for mileage if you live out of town. If you qualify to participate in one of our clinical trials, you will receive detailed information from a study coordinator about the available stipends, number of visits required, and the overall trial schedule.
How do I get qualified?
There are many factors that weigh in on whether or not you qualify for a particular trial. These guidelines are determined by the pharmaceutical sponsor conducting the trial. Your medical history and current state of health will help us identify if you are a good candidate for any of our clinical trials.
What are the risks and potential side effects?
As with any medication you take—prescribed, over-the-counter, and investigational—there are risks and potential side effects. There is also a possibility that the medication provided may not be effective in treating your health condition.
The specific risks and potential side effects of the medication that your trial is evaluating will be outlined and provided to you in a detailed informed consent document. After reviewing the document, you will have a better understanding of the medication to make a decision about participating. If you have questions or concerns at any point during your health screening, while reading your trial paperwork, or during your trial participation we encourage you to contact us so that we can help.
Will the study drug affect my other medication?
The sponsors of our clinical trials want to ensure safe participation for everyone involved. They have done their due diligence with medical professional direction to identify any health conditions or medications that may be adversely affected by a trial treatment plan. If there is any potential risk related to your personal health, that risk will be identified and fully explained to you prior to your trial participation. That risk may also result in disqualification to participate in a trial.
How long is a clinical trial and how much time will it take?
The duration and frequency of visits of each clinical trial varies depending upon the medication and/or treatment plan being studied. We will provide the specifics of your clinical trial when we determine which one(s) you are interested in and may qualify for.
Does participating in a trial affect my health insurance?
Your health insurance is not affected by trial participation. As part of the Affordable Care Act, health plans and insurers cannot deny your participation in a clinical trial, limit or deny coverage of routine costs, or increase costs as a result of your choice to participate in a clinical trial. Your insurer cannot limit your benefits if you choose to enroll in a clinical trial.
Will I have access to treatment after the study?
The medication provided to you during the trial will no longer be provided after your last study visit. It may be possible that you can have the medication prescribed to you by your Dermatologist if it is already FDA approved. However, if it is not yet an approved medication, you may have to wait to see if/when the medication is approved before you would have access to it again.
If you do not have a Dermatologist and would like to continue seeing one of our providers for your ongoing health needs, this is also an option to you. Ask us for more information.
Can I do another trial after I finish this one?
Yes. If you are a qualified candidate for another one of our clinical trials, you may be eligible to begin another trial. There is usually a 30-day waiting period in between trials.
Can I do more than one trial at a time?
Unfortunately, no, you can only participate in one trial at a time.
Why do people participate in clinical trials?
New Treatment Options
- The most common reason patients enroll in clinical trials is the lack of a generally accepted therapy—or ineffectiveness of available therapy—for their health condition. Participating in a clinical trial may offer a new alternative to the current standard treatment before it’s available to the general public.
Better Health for Future Generations
- Many people volunteer for participation because they have a potentially hereditary health problem such as osteoporosis, diabetes, or high blood pressure, and they want to do all that they can to improve the available treatment options and medications for that condition for future generations.
- Participation in a clinical trial gives you the opportunity to develop a close doctor-patient relationship in which you could receive trial medication and treatment for the duration of the trial absolutely free of cost. Some trials may also provide monetary compensation for your time and effort involved with the trial. This can be especially helpful to those individuals on a fixed budget, those without access to health insurance, and those on high deductible health plans.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. Additionally, most clinical research is federally regulated with built-in safeguards to protect participants. Clinical trials follow carefully controlled guidelines (protocols) that detail and direct what researchers will do in the trial.
Should I continue to see my primary health care provider while in a trial?
Yes. While most clinical trials provide short-term treatments related to a specific illness or condition, they do not provide extended or comprehensive primary health care after your trial has ended. It is also important that your primary health care provider is aware of your participation in a trial so that they can ensure that any new prescriptions do not conflict with trial guidelines.
Can I leave a clinical trial after it has begun?
Yes. You may leave a clinical trial at any time; however, we do ask if you need to withdraw from a trial, that you inform the research team and share your reason(s) for leaving the trial.
What is a placebo?
A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment’s effectiveness. In some trials, participants in the control group will receive a placebo instead of an active drug or experimental treatment.