Participating in a Clinical Trial – Frequently Asked Questions
Why are clinical trials conducted?
Clinical trials are essential to the development of new interventions (drugs, procedures, devices etc.) that help people to live longer and with less pain or disability. They help researchers to understand what does and doesn’t work in humans that cannot be learned in the laboratory or in animals. Clinical trials also help doctors decide if the side effects of a new treatment are acceptable when weighed against the potential benefits. Clinical trials are also required by the health agencies prior to approval and commercialization.
Your participation in a clinical trial can help the medical community bring new, life improving medications and treatment options to patients with multiple sclerosis.
What is the difference between a Phase II Trial and Phase III Trial?
Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In Phase II trials, the study drug or treatment is given to a smaller group of patients (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely. Phase III trials are the last step before an investigational drug is approved for general use. The trials listed on Mymstrials.com are all phase III trials.
Why Should I Participate?
Your participation in a clinical trial can help the medical community bring new, life improving medications and treatment options to patients.
If you choose to participate in a clinical trial, you may receive investigational drugs, medical treatment and/or procedures at no cost.
How Do Clinical Trials Work?
Clinical trials follow rigid drug testing procedures designed to help researchers determine the safety and effectiveness of the drug or medical treatment being studied.
The Food and Drug Administration (FDA) has a set of regulations that must be followed when bringing a new drug or treatment to market. Clinical trials conduct research and collect data in alignment with these FDA regulations.
Who Can Participate in a Clinical Trial?
Every clinical trial has a set of criteria that trial participants must meet in order to participate, including agreeing to signing an informed consent form and HIPAA authorization.
The ability and willingness to travel to the location of the clinical trial is also required. (Travel can be frequent)
If you are interested in participation, visit Mymstrials.com to pre-qualify online (done privately, and takes 30 seconds)
Are medical care expenses covered in association with the trials?
Yes, 100% of medical care you receive in relation to the trials is covered by the trial sponsor. There is no insurance required to participate, no deductibles, no fees whatsoever. If you participate, there will be no cost for exams, MRIs, study drugs, and other related medical care.
What type of medical care is provided during the study?
During your in-person visits, medical care will take place (at no cost to the patient) including but not limited to, physical examination (including check of blood pressure, heart rate and body temperature) blood and urine sampling, study medication dispensation, MS related tests, questionnaires related to your quality of life, periodic brain MRI, EKG. A full schedule of participation activity will be shared with you at the beginning of the study.
Will I receive the study drug if I participate in the phase III trials found at MyMSTrials.com?
Half or more of all participants will receive the study drug: Tolebrutinib. For the Gemini I and Gemini II trials, half will receive Tolebrutinib and half will receive an existing MS Medication: teriflunomide. For Perseus and Hercules trials, two-thirds will receive the study drug, and one-third will receive a placebo.
What is a placebo?
A placebo is an inactive pill that has no active treatment. In clinical trials, experimental treatments are compared with placebo to better evaluate the treatment’s effectiveness.
All patients should consult their doctors before considering participation in a clinical trial.