FAQs About Dermatology Research
If you are considering participating in one of our clinical research trials, it's likely you have many questions. This page answers the questions most frequently asked by our potential participants.
- How is the safety of the participant protected?
- Will I be compensated for my time and travel? What will I receive?
- Why would a pharmaceutical company need to conduct research on a drug?
- Who can participate in a clinical trial?
- What happens during a clinical trial?
- What is informed consent?
- What should I consider before participating in a trial?
- How should I prepare for the meeting with the research coordinator, doctor, nurse practitioner or physician's assistant?
- Should I continue to see my own health care providers while in a trial?
- What are side effects and adverse reactions?
- What are the benefits and risks of participating in a clinical trial?
- Can I leave a clinical trial after it has begun?
How is the safety of the participant protected?
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians and community advocates that ensures a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
The Center for Skin Research follows a carefully-controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.
Will I be compensated for my time and travel? What will I receive?
For most studies, The Center for Skin Research gives participants a monetary stipend to offset the cost of time and travel. The amount is determined by the pharmaceutical company sponsoring the study and varies depending on the number of office visits required, the length of the study and the treatment being tested. It generally ranges somewhere between $150 and $300.
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There are non-monetary benefits of participating in a clinical trial as well. For one, you will receive investigational treatment of your skin condition at no cost, with no insurance coverage required. Once you enroll in a trial, you receive the same care you would receive if you were a medical dermatology or cosmetic dermatology patient. You will receive an examination and diagnosis by a board-certified dermatologist or certified physician's assistant and have the opportunity to ask questions about your condition. At the end of the study, your dermatologist will make a recommendation for continued treatment of your condition.
Why would a pharmaceutical company need to conduct research on a drug?
There are several reasons why pharmaceutical companies would need to conduct a study. For example, the pharmaceutical company may be testing the generic version of a name brand medication that is already on the market. In other instances, the pharmaceutical company may want to test a medication that is on the market for one purpose to see if it can be used to treat another medical condition. For example, an antibiotic that is on the market for respiratory tract infections, such as pneumonia, is also used to treat acne. If you are interested in a study and want to know the reason it is being conducted, ask the Research Center's staff during your initial call.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. These guidelines, which differ from trial to trial, are based on factors like age, gender, the type and stage of a disease, and other medical conditions. The factors that allow someone to participate in a clinical trial are called "inclusion criteria." The factors that keep someone from participating are called "exclusion criteria." Using inclusion/exclusion criteria is an important part of medical research that helps to produce reliable results and protect the safety of participants.
If you think you may qualify to participate in a trial, call The Center for Skin Research at (713) 985-0210. We will conduct a brief telephone screen and determine whether a particular clinical trial is right for you. If you pass the telephone screening, then we will schedule an in-office appointment with our doctors and research staff to see if you meet the inclusion criteria and to explain the particular requirements of the study. We will also answer any questions you may have about participating in the trial.
What happens during a clinical trial?
Every clinical trial at The Center for Skin Research starts with a screening process that ensures each candidate is eligible to participate. Once you enroll in a trial, you receive the same care you would receive if you were a medical dermatology or cosmetic dermatology patient. We cater to our patients and offer the same nurturing environment that is found in all divisions of the practice.
Your research team, which consists of doctors, physician assistants, nurse practitioners, nurses and clinical research professionals, will give you specific instructions for participating in the trial. Depending on the investigational treatment being tested, you may be asked to take a pill, apply a topical ointment or come in for therapy. All studies require regular visits to The Center for Skin Research so that your research team can monitor your progress. Some trials last as long as 18 months, while others are as short as 8 weeks. During this time, you will receive monetary compensation for your time and travel.
What is informed consent?
The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Participants must sign an "informed consent" form before joining the study, indicating they understand that the trial is research, and that they can leave the clinical trial at any time. This informed consent helps ensure that a prospective clinical trial participant understands what's involved in the trial.
What should people consider before participating in a trial?
Answers to these questions may be helpful in making your decision:
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- Is any long-term follow-up care part of this study?
- How will I know that the experimental treatment is working? Will results of the trial be provided to me?
- Who will be in charge of my care?
How should I prepare for the meeting with the research coordinator, doctor, physician's assistant or nurse practitioner?
Your initial meeting with the research team is your chance to ask questions and determine whether a clinical trial is right for you. You may want to consider doing the following:
- Write down possible questions to ask.
- Bring a friend or relative for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion to replay later.
Should I continue to see my own health care providers while in a trial?
Yes. Our clinical trials provide short-term treatments for skin-related conditions supervised by our board-certified dermatologists, physician assistant or registered nurse, but do not provide extended or primary health care. You should still see your primary care physician or specialist for any health issues that are not related to the trial. You may, however, be asked to suspend treatment previously prescribed by your dermatologist or any other treatment that may conflict with the research study's protocol.
What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the experimental drug or treatment. Experimental treatments must be evaluated for both immediate and long-term side effects. You will be asked at each visit if you have experienced any adverse effects or changes in your health since your last visit whether you think they may be related to the trial drug or not.
What are the benefits and risks of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best way for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at a leading health care facility during the trial.
- Help others by contributing to medical research.
You should also be aware of potential risks with clinical trials.
- There may be unpleasant, serious or even life-threatening side effects to an experimental treatment. If serious side effects occur, The Center for Skin Research will halt treatment immediately.
- The experimental treatment may not be effective for the participant.
- The study may require more time and attention than a non-study treatment, including trips to the study site, more treatments or complex dosage requirements.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial at any time. When withdrawing from the trial, the participant should let The Center for Skin Research know that they would like to withdraw and their reasons for withdrawing.
Source: National Library of Medicine, "Participation in Clinical Trials." Available at: http://www.clinicaltrials.gov/ct/info/resources. Accessed February 12, 2008.