Characteristics of Participating in a Multiple Sclerosis Clinical Trial

  • So you are thinking about whether to participate in a clinical trial?  There is much to know in making your decision.  In the past few weeks, we have been discussing many of the the important things you need to know (see Part One and Part Two).  In this post, we will explore aspects of participating in a clinical trial.

     

    As often promoted, patients who participate in clinical trials may gain access to new treatments before they are widely available, help others by contributing to medical research, and receive trial-related medical care.  But not everybody is eligible to participate in any clinical trial.  There are inclusion/exclusion criteria which come into play based on such factors as "age, gender, the type and stage of a disease, previous treatment history, and whether you have other medical conditions."

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    Inclusion/exclusion criteria make sure that researchers will be able to answer the specific questions posed in the trial protocol.  Some research studies need participants with specific illnesses or conditions to be studied in the clinical trial, while others need healthy participants.

     

    ClinicalTrials.gov shares that the clinical research team is responsible for checking your health at the beginning of the trial, will give you specific instructions for participation during the trial, monitor you carefully during the trial, and stay in touch after the trial is complete.  Since some clinical trials involve more tests and doctor visits than you might normally have for an illness or condition, this might be a viable way to obtain needed medical care if you are uninsured. 

     

    A bloggery friend of mine, Jeri of Fingolimod and Me, has been in the fingolimod (Novartis) trial and she is one who has used her trial to obtain medical care in addition to gaining access to the drug being studied.  She is unsure of just how she's going to regain access to the drug which has helped her so much during recent years (not to mention that it's difficult to obtain medical care when you are on Medicaid) when the drug becomes FDA-approved and her extension trial ends.

     

    "To help someone decide whether to participate in a specific clinical trial, the doctors and nurses involved will explain the details... about the study, including its purpose, duration, required procedures, and key contacts."  This is part of the informed consent process.  The official informed consent document must also explain the risks and potential benefits involved.

     

    You should feel comfortable asking questions about any of the information presented, and it is this point at which you must decide whether or not to sign the document and join the trial. Keep in mind that "informed consent is not a contract" and you can leave a clinical trial at any time. When withdrawing from the trial, you should let the research team know and tell them the reasons you are leaving the study.  Don't just simply not show up for your scheduled appointments.

     

    In treatment trials, it is especially important that participants report any side effects or adverse reactions.  As we discussed last fall the comments section of FDA, Social Media, and Pharmaceutical Advertising, it is difficult to determine if something is a side effect or an adverse reaction.  Even our doctors do not agree often on what is worth reporting.

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    Here is what ClinicalTrials says on the subject.  "Side effects are any undesired actions or effects of the experimental drug or treatment.  Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects."  Look at the full prescribing information for any of our medications and you will find examples of side effects which were reported during the trials of that medication.

     

    Many trials include a quality of life assessment as part of the bigger trial, especially if the trial is designed to compare treatments. It is either included as part of the main trial or is classified as a separate "quality of life study."

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    You will probably be asked to fill in some questionnaires as part of the study and/or may be asked to keep a diary which could contain notes about how you are feeling after your treatment, or when you get a particular side effect and how long it lasts.

     

    Some of the questions asked at each appointment may seem odd, but it is important to know how treatments affect people, in addition to knowing how well they work clinically. Improving patients' quality of life is often an important goal of treatment. Patients are more likely to stick with a treatment if it has fewer side effects or is more convenient, which is just plain common sense if you think about it.

     

    As mentioned in Part Two, researchers must design a carefully controlled protocol BEFORE the study begins.  Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. You may read more about an Institutional Review Board on the FDA website.

     

    As a clinical trial progresses, researchers report the results of the trial at scientific meetings (such as ECTRIMS or AAN), to medical journals (such as NEJM or The Lancet), and to various government agencies (such as the FDA and NIH). Note that individual trial participants' names are never revealed in these reports.  It is from the reports and abstracts of meetings of ECTRIMS (European Committee for Treatment and Research in Multiple Sclerosis) or the AAN (American Academy of Neurology) where we first learn the promising or disappointing early results of these trials.

     

    How do I find a clinical trial in which to participate?

     

    The most complete listing of clinical trials - completed, open, recruiting, not recruiting - is found at ClinicalTrials.gov, a service of the National Institutes of Health.  Trials can be found by disease condition, drug intervention, sponsor, or location.  One can also search simply by using keywords in the search box to narrow down the results.

     

    Currently, a search for “multiple sclerosis” turns up 558 clinical trials, 209 of which are seeking new volunteers.

     

    The following are trials listed by disease condiiton:

  • It is a personal decision whether or not to participate in a clinical trial, but please know that researchers need willing participants to help further the science of MS treatment.  Maybe eventually, the scientists will stumble upon that elusive cure.... one can hope.

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    If participating in a clinical trial involving an investigational medication is not of interest to you, then you may want to consider participating in an MS registry or tissue donation bank.   We discussed these types of projects in the post - MS Research and Registries - which was outlined NARCOMS, Accelerated Cure Project, and Brain Tissue Donation.

     


    SOURCES:
    Understanding Clinical Trials from ClinicalTrials.gov

    Clinical Trial Basics from National MS Society

    Types of Trials from CancerHelpUK

    Fingolimod and Me by Jeri/Tinkled Pink

     

    MORE INFORMATION ON HEALTHCENTRAL:

    MS Research and Registries

    Clinical Trials I: What You Need to Know

    Clinical Trials II: Phases and Protocols

    Clinical Trials III: Patient Participation

     

    Lisa Emrich is author of the blog Brass and Ivory: Life with MS and RA and founder of the Carnival of MS Bloggers.

Published On: February 24, 2010