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New treatments await--if they can be tested: the challenges of clinical trials recruitment.

Clearly one of the most exciting aspects of MS research today is the number of experimental therapies in the late stages of clinical studies. In 2002, according to the Society's list of Clinical Trials in MS, there were only three large-scale studies recruiting more than 1000 people with MS; the 2008 list contains 11 such studies! These large, phase 3 studies are essential for gaining a better understanding of a new drug's safety and effectiveness.

Together, the 136 studies on the 2008 list have recruited, or are in the process of recruiting, more than 35,000 people to participate in clinical trials of MS agents. This is a difficult task. Investigators usually have strict criteria by which they determine who may enroll in a study. On the patient side, participation requires a careful process of weighing the potential benefits and risks of possibly foregoing conventional therapies for the chance to try something new.

There also are aspects of MS that make patient recruitment particularly challenging. For example, some studies require that participants have never taken a disease-modifying agent. But, since the Society's National Clinical Advisory Board, among others, recommends that people diagnosed definitively with MS consider treatment as soon as possible, this is a hard group of people to find. Also, people in the early stages of MS, whose symptoms might be mild, may not consider or desire enrolling in a clinical study.

Getting the word out

We're trying to help bring investigators and patients together through our online database of studies nationwide that are recruiting patients with MS. The database includes a section listing international studies. Thirty-six studies are currently recruiting patients and are listed with sites throughout the U.S. and in 11 other countries. The database is searchable by state and by type of MS.

Our clinical trials section also provides valuable information on what you need to know before getting involved in a clinical study, and guidelines for making that decision. Visit this valuable resource at recruiting.

Seeking another gold standard We also are making efforts to improve the process of clinical research by seeking alternatives to currently accepted trial designs and outcome measures, which are the mechanisms by which investigators determine the efficacy and safety of medications. Our International Advisory Committee on Clinical Trials in MS (IACCTMS) is greatly involved in this effort. They are working with Gary Cutter, PhD, head of the Section on Research Methods and Clinical Trials at the University of Alabama School of Public Health, to evaluate other clinical trial design strategies that might be more efficient, faster, and require fewer patients.

Furthermore, we are addressing changes in MS drug development. Our current FDAapproved disease-modifying treatments offset the immune attack on the brain and spinal cord, but none as yet directly addresses protecting nerve fibers, damage to which contributes significantly to progressive disease. Slowly, we are seeing more "neuroprotective" agents under study in MS. They include riluzole, a drug used to treat ALS ("Lou Gehrig's disease"), and the cannabis derivative dronabinol.

A panel convened by the IACCTMS has recommended that neuroprotective studies include people with actively progressive disease and that the studies evaluate clinical signs and symptoms as well as MRI outcomes. They also recommended boosting the number of neuro-protective agents under study by using "weeding" studies, in which multiple treatments are tested simultaneously in smaller trials to determine which might succeed in larger efforts. (Multiple Sclerosis 2005;11:669-676)

Taking a balanced approach Making it easier to study drugs should not come at the cost of patient safety. The IACCTMS led a task force on the ethics of placebo-controlled trials in MS which recently updated its recommendations. (Neurology 2008;70:1134) The use of placebos--"dummy" medications--as a control group for experimental therapies when there are multiple agents available to treat relapsing forms of MS has been of growing concern.

The task force recommended the use of placebo only in carefully chosen and conducted studies. In these clinical trials it is important that participants understand that other treatment options are available but that they are refusing these established, effective therapies in order to take part in the new placebo-controlled clinical trial.

The task force's recommendations highlight the great importance of the process of "informed consent." This is usually thought of as the long, technical document that people sign when enrolling in a study, but actually it's a process that continues throughout the study. The task force suggests using, when possible, a health professional or informed lay person who is not a member of the research team or affiliated with the sponsor to help the patient volunteers make autonomous decisions and to maintain his or her understanding of that decision throughout the study. They also recommend counseling and re-consenting during a placebo-controlled trial if there is a disease relapse or if an individual's disease otherwise worsens during the study. We require that placebo-controlled studies listed on our Web site adhere to the recommendations of this task force.

As clinical research in MS heats up, we need to ensure that this long, complicated process gets easier for all of those involved, and yet remains safe and productive. We are proud to be guiding and facilitating this exciting era, as it will surely help us to stamp out MS.

Dr. John Richert is executive vice president for the society's research & clinical Programs.
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Title Annotation:Research Now
Author:Richert, John R.
Article Type:Clinical report
Date:Sep 22, 2008
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