Clinical Trials for Multiple Sclerosis: What You Need to Know
Have you ever considered participating in a clinical trial? I have, yet... I haven’t.
ClinicalTrials.gov provides "patients, family members, health care professionals, and members of the public easy access to information on clinical trials for a wide range of diseases and conditions." The U.S. National Institutes of Health (NIH), through its National Library of Medicine (NLM), developed the site in collaboration with all NIH Institutes and the Food and Drug Administration (FDA).
It's useful to know that there are different types of clinical trials:
Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy; Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. (ie. medicines, vaccines, vitamins, minerals, or lifestyle changes); Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition; Screening trials test the best way to detect certain diseases or health conditions; and Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.
Yesterday, I received an email from a communications company (PR agency) who was hired to “create awareness regarding two clinical research studies in multiple sclerosis.” The studies are being conducted to compare safety and efficacy of alemtuzumab (Campath) with Rebif (interferon beta-1a) and are Phase 3 trials.
When considering participation in clinical research, it is useful to know the purpose or the phase of the trial. Clinical trials are conducted in phases with each having a different purpose and to help scientists answer different questions:
Phase 1 trials are initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase 2 trials are controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
Phase 3 trials are expanded controlled and uncontrolled trials during which the study drug or treatment is given to large groups of people 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 4 trials are post-marketing studies intended to delineate additional information including the drug's risks, benefits, and optimal use of the approved therapy.
If you are interested in participating in a clinical research study, search Multiple Sclerosis studies in ClinicalTrials.gov. Or consult the clincal trial resource page hosted by the National MS Society.
I'm curious. Have you ever participated in a clinical trial? If so, what was your experience like and would you recommend that experience to others?