Frequently Asked Questions concerning MDRI’s clinical trials and studies, who can participate, and what to expect if enrolling in one of our trials.
Before a new drug or treatment is approved by the U.S. Food and Drug Administration (FDA), it must be shown to be both safe and effective. This can be accomplished through clinical research trials, which are controlled trials to test and investigate study medications. There are no costs associated with participation and volunteers are typically reimbursed monetary amount for their participation. There are four different phases for a clinical research trial.
- Phase I studies assess the safety of a drug or device and usually involves fewer study volunteers than later phases. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased.
- Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second “control” group receives a standard treatment or placebo. Often these studies are “blinded” which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug.
- Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of
the drug or device, the benefits and the range of possible adverse reactions. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug. - Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. During phase IV studies pharmaceutical companies wish to compare the drug with current therapies, monitor long-term
efficacy, and determine cost effectiveness compared to other therapies.
Every clinical research study has a different set of inclusion and exclusion criteria to qualify for the study, all of which have been approved by an Institutional Review Board. These qualifications are based on the extent of the disease being investigated, medical history, and laboratory
values. Patients may be “pre-screened” via telephone for baseline qualifications; more extensive testing is performed during a scheduled “screening visit”. Taking part in any study is voluntary. You may choose not to take part or may leave the study at any time. If you agree to take part
and then decide against it, you can withdraw for any reason without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care.
Study Visits:
- Patients typically need to allow 1-3 hours for their study visits. During these visits, the patients will be requested to fill out study questionnaires, have their vital signs taken, labs drawn, physical exam/assessments by a physician, and receive study medication.
Study Termination:
- Subjects may decline participation and/or withdraw consent and at any time. A study termination visit will still be necessary, even though study drug will no longer be administered.
Trial Completion Visit:
- During their final scheduled visit, the subject completes their participation in the study. This is usually an abbreviated visit to follow up on adverse events; it typically occurs a month after the final dosage of medication; however, all studies have individual requirements and timelines.
Qualified study participants will receive study drug, related testing at no charge to the clinical trial participants. Also, they will receive compensation for their time and travel.
All clinical trials are scrupulously reviewed by the FDA, Institutional Review Board (IRB), our physicians and staff to ensure the utmost safety for all trial participants with the goal of minimizing side effects.
- You particularly will receive a treatment that works for you that you would otherwise not have access to
- You will be closely monitored by our experienced medical staff
- You could be helping others in the future with a successful treatment
- You will receive compensation for your participation
Pfizer, Abbvie, Boehringer-Ingelheim Pharmaceuticals, Novartis, Incyte, Bristol-Myers-Squibb, Innovaderm, Arcutis, Eli-Lilly and Company, Allergan, Amgen, Anacor, Apopharma, Avillion, Dermira, Galderma, Janssen, Leopharma, National Institute of Health, Regeneron, Sandoz, Sienna, UCB Biopharma SRL, Xenoport, Mindera, Aslan.
Typically studies will require a clinical diagnosis prior to enrollment, and will request medical records from patients to affirm the date of diagnosis.
A placebo is a treatment containing all compounds present in the investigational product except the active ingredient. It is necessary in clinical trials to have something to compare results to. In some cases this is a different medication (which might compete directly to the investigational product), and other times it can be a placebo. This is to ensure that the results obtained from the study are valid, and an improvement when compared to a comparator or placebo.
BSA is determined by measuring the number of handprints of involvement present. A handprint includes the palm and the fingers as shown in the image. 1-handprint is approximately equivalent to 1% of body surface area. In other words, if a study requires 10% – this will equate to 10-handprints.
A long-term extension follows an initial study. All patients on these studies will receive medications, typically for a longer time period of one to several years. During that time, patient visits are typically less frequent (every few months).
This is an observational study where patients are followed to track treatments (medications, efficacy, length of time used), side effects, complications, and other medications & medical conditions. This can help identify trends or highlight associations to help guide treatment for patients in the future.
No, your participation is voluntary and you are free to withdraw from trial at any time. Before consenting to participate in a clinical trial the study will be reviewed with you in full, including: the risks/benefits, protocol, appointments, and answer any questions you may have to the best of the staff’s ability. Should you feel you can no longer participate we simply ask that you notify us of your decision.
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