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 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 an investigational treatment are acceptable when weighed against the potential benefits. Clinical trials are also required by the health agencies prior to being sold and prescribed by healthcare professionals.
How Do Clinical Trials Work?
Clinical trials must adhere to Good Clinical Practices (GCP), rigid standards that clearly state what is allowed by medical professionals during a clinical trial.
Clinical trials follow rigid drug testing procedures designed to help researchers determine the safety and effectiveness of the investigational 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.
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 investigational study drug or treatment is given to a smaller group of patients (100-300) to do a preliminary assessment of its efficacy and safety to help decide whether and how to conduct a Phase III trial.
In Phase III trials, the investigational study drug or treatment is given to large groups of people (1,000-3,000) to assess its effectiveness, monitor side effects, compare it to commonly used treatments, and collect other information about the safety of the investigational drug or treatment. If they are successful, phase III trials are the last step before an investigational drug is submitted to the FDA requesting approval for general use. The trials listed on www.mymstrials.com are all phase III trials.
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)
Are travel expenses reimbursed?
Yes, if you need to travel to attend the study visits, all travel related costs are reimbursed including meals, hotel, transportation, and airfare.
Are study-related medical care expenses covered in association with the trials?
Yes, 100% of study-related medical care you receive in relation to the trials is covered by the trial sponsor. There is no insurance required to participate. If you participate, there will be no cost for study-related exams, the investigational study drugs, and other study-related medical care.
What type of study-related 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 investigational study drug if I participate?
Half or more of all participants will receive the investigational study drug: tolebrutinib. For the Gemini I and Gemini II trials, half will receive tolebrutinib and half will receive an existing MS Medication: Aubagio® (teriflunomide). For Perseus and Hercules trials, two-thirds will receive the investigational 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, investigational treatments are compared with placebo to better evaluate the investigational treatment’s effectiveness.
What about clinical trials participation during COVID-19?
This study requires in-person visits to the study site. Precautions are being taken to reduce the on-site risks of exposure to COVID-19. Each individual site location will review their protocols including mask wearing, social distance, pre-appointment check in. Study sites are medical facilities where COVID safety procedures are followed.
If you are or plan to be vaccinated with COVID-19, you may still be eligible for the studies. The COVID-19 vaccine can be administered before entering in the study or afterwards, without needing study drug interruption. This should be discussed with your study doctor.
In order to ensure treatment continuity and safety of patients participating in our clinical trials during this worldwide pandemic, several alternative solutions have been put in place and can be accessed if they are available in your area:
- Investigational study drug can be sent directly to you at home, to ensure that you will receive the investigational study drug even if you are unable to come to the research center/hospital/clinic
- Telehealth/video consultation can be organized instead of on-site visits
- Some study visits can be performed at home, via Home Nursing Program
- Have the possibility to sign your consent either on paper or electronically (eConsent) in a patient App.
Can I speak with someone if I have questions?
For additional details about the trials you can visit clinicaltrials.gov
Who is sponsoring these trials?
Sanofi is the trial sponsor. See more details about Sanofi online here.
How Are Clinical Trials Conducted?
Clinical trials usually take place at a local hospital, medical clinic, or research facility, and care is provided by licensed physicians and/or medical researchers at the trial site.