Why should I participate in a clinical trial?
Participating in a clinical trial may potentially improve your specific skin condition or overall health. Clinical trial volunteers help advance the field of medical and cosmetic dermatology.
What safeguards are in place to protect me as a clinical trial volunteer?
First and foremost, a clinical research coordinator will provide you with a thorough written and verbal description of all the information you will need to make an informed decision about joining a clinical trial—a process known as informed consent. The consent form will include a detailed discussion of potential risks and benefits, information about the study schedule and duration, and contact information for the physician and company sponsor overseeing the clinical trial. All clinical trials will adhere to a strict predetermined protocol that outlines exactly what will and may take place during the course of the study.
Will my participation in a clinical trial be confidential?
All information, including medical, personal, or other information obtained during a clinical trial, will remain confidential and is protected by state and federal regulations governing clinical research. Personal information will only be released with your explicit authorization.
Is there a cost to participating in a clinical trial?
In some studies all medical care related to the clinical trial, including exams, laboratory tests, and medications, is provided at no charge to you. In some studies there is a reduced cost for participants. Certain clinical trials may also reimburse you a flat fee to cover your travel and time expenses.
How long does a clinical trial last? How long is each visit?
Each clinical trial is different. This information will be provided to you in the consent paperwork. The length of each office visit may also vary significantly, depending on the study. The initial visit usually lasts 30-90 minutes, while subsequent visits may be far shorter.
Who will be diagnosing me and/or giving me medical advice? Who decides if I am eligible to participate in a clinical trial?
A board-certified physician will diagnose you and/or offer medical advice. Both the physician and a clinical research coordinator will determine if you are eligible for a specific clinical trial.
I already see a doctor on a regular basis at Cleaver Dermatology. Can that physician oversee me in the clinical trial?
Not all of our physicians participate in the clinical trials. Participating physicians vary per study. You will be able to continue to see your established physician for regular medical visits, but will see a physician participating in the study for visits relating to the clinical trial. Clinical research appointments cannot be combined with any other type of patient visit.
What determines eligibility for a clinical trial?
The clinical research team will determine whether you are an appropriate candidate for a clinical trial based on specific inclusion and exclusion criteria. These criteria will be described in detail in the consent paperwork and study protocol and may vary significantly between different clinical trials. Inclusion criteria are characteristics that someone
What if I want to leave a clinical trial?
You are free to leave or cease participation in a clinical trial at any time for any reason. Details about why you have decided to leave the study are appreciated but not mandatory. Depending on the type of clinical trial, the clinical research team may offer you recommendations (i.e. if a study medication needs to be withdrawn gradually), but again, this is not required.