• Patients & Families

• About CARE-MS Studies
  • About CARE-MS I
  • About CARE-MS II
• Patient Prescreener
• About Clinical Studies

• ClinicalTrials.gov
  Registry of federally and privately supported clinical studies conducted in the U.S. and internationally.
  

• U.S. Food and Drug Administration Comprehensive, Web-based resource of clinical study information.
  

• The Center for Information & Study on Clinical Research Participation Dedicated to educating and informing stakeholders about clinical study participation.
  
  
• National Multiple Sclerosis Society Descriptions of the clinical research process and a database of ongoing clinical studies in MS.

About Clinical Studies

According to the U.S. Food and Drug Administration (FDA), a clinical study is a research study conducted in human volunteers that determines whether a new drug is effective and safe. Carefully conducted clinical studies may lead to new treatments and methods of improving health.

Clinical Study Participation

There are generally known and unknown risks and benefits associated with participation in clinical studies, such as:

• The treatment may not be effective for the participant.
• The clinical treatment plan may require more of the participant's time and attention than a standard treatment. (Participants may need to visit the study site on a regular basis, be subjected to additional tests, receive more treatments than is normally necessary, stay in the hospital, and/or follow complex dosage requirements.)
• There may be unknown and potentially serious, or even life-threatening, side effects resulting from the treatment and/or study procedures.

Participating in clinical studies is one approach for eligible patients to volunteer to possibly help others by contributing to medical research.

To determine who is eligible to participate, clinical studies establish guidelines called inclusion and exclusion criteria. Inclusion criteria are the factors that make an individual eligible, while exclusion criteria are those factors that prevent an individual from participating. These guidelines are intended to protect participants’ safety and ensure researchers are able to secure answers to the questions they intend to study. Factors which may be considered include:

• Age
• Gender
• Type of condition
• Disease stage
• Medical history

Informed Consent Process

A person with MS who has met all of the eligibility criteria and may be interested in participating in one of these studies must go through the informed consent process which begins with a visit at a study doctor's office. During the initial visit, the study will be fully explained to you, and you will have an opportunity to ask questions. Then, if you are interested in further screening, you will be asked to sign an informed consent document, which explains all aspects of the study including possible risks and benefits of the study drugs and procedures. The informed consent process also ensures you understand that the study is voluntary and that you can leave the study at any time.

After you have signed the informed consent document, the study doctor will determine your eligibility based on clinical criteria. You may be given a physical examination and certain laboratory and other tests. If your results meet the entrance criteria and if you agree to participate, you will be enrolled.

To learn if you may prequalify to participate in CARE-MS I or CARE-MS II, complete the online prescreener now.