More MS news articles for June 2001

Clinical Trial Design Important Consideration for Neurologists Evaluating MS Therapy

'Meaningful Clinical Endpoint,' Double Blinding, Trial Size and Duration 'Extremely Important' to Vast Majority Surveyed

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ROCHESTER, N.Y., June 18 /PRNewswire/ --

Harris Interactive (Nasdaq: HPOL), a worldwide market research and consulting firm, announced today the results of a survey that shows what neurologists feel is important as they evaluate the effectiveness of different treatments for multiple sclerosis (MS).  The substantial majority of neurologists surveyed say that the design of the clinical trial in which the treatment was tested is a very important consideration.

According to the study, three out of four neurologists in the U.S. consider clinical trial design very important when they judge the effectiveness of an MS therapy.  And, when evaluating the design of a trial, equally large majorities think it extremely important that the trial be double-blinded, have a "meaningful clinical endpoint," be randomized, include a sufficient number of patients and last for a sufficient amount of time.

The most important requirement of a trial, according to those surveyed, is that it have "a meaningful clinical endpoint" -- in other words, that the clinical outcome measured in the trial be clearly recognized as an appropriate objective in the treatment of MS patients.  And, among possible outcome measures, the vast majority of neurologists consider "sustained disability progression" (80%) to be a more significant measure than number of relapses experienced (20%).

"The survey shows that when deciding which therapies to prescribe to their patients with MS, neurologists pay attention to the clinical trials in which these therapies were tested," said Bob Leitman, Group President for Healthcare, Public Policy and Education Research at Harris Interactive. "Furthermore, doctors appear to be reasonably savvy about trials -- paying attention not only to 'the results', but also to how these results were obtained, recognizing that some trials are, in fact, better than others."

In addition to a "meaningful clinical endpoint", the next most important requirement, according to the physicians surveyed, is that the trial be double-blinded.  With double blinding, the physician, as well as the patient, is unaware of whether the patient is receiving the treatment being tested, or an alternative treatment or a placebo.  Double blinding is generally considered an essential element of good trial design in order to avoid bias.

Other requirements of clinical trials considered most important by survey respondents included having a sufficient number of patients, lasting a sufficient amount of time, and being randomized.  For the typical neurologist, somewhere around 200 patients is the minimum number that should be included in a clinical trial for an MS therapy.

With regard to the minimum duration of a trial, relatively few neurologists (12%) think that less than one year is a sufficient amount of time to show a significant effect on a clinical outcome.  A much larger proportion (49%) of neurologists thought that between two and three years is the minimum amount of time required for a clinical trial, and one in four (25%) felt more than three years would be necessary to demonstrate a significant effect on clinical outcomes.

"Most neurologists want clinical trials that last long enough to demonstrate the long-term efficacy and safety of MS therapies," says Leitman. "This is consistent with the chronic nature of this disease and neurologists' strong preference for clinical trials where the measured outcome is sustained disability progression."

Survey Methodology

This survey, commissioned by Biogen, Inc., was conducted online by Harris Interactive during April 2001 with 251 neurologists who treat MS patients. The survey averaged approximately 13 minutes in length.

About Harris Interactive

Harris Interactive (Nasdaq: HPOL) is a worldwide market research, polling and consulting firm.  It is best known for The Harris Poll and its pioneering use of the Internet to conduct scientifically accurate market research.  The Harris Interactive Internet-based forecasts for the 2000 election were the most accurate in the history of the polling industry.  With expertise in pharmaceutical, health care, automotive, finance, ecommerce, technology, consumer packaged goods and other markets, the firm has spent 45 years providing its clients with custom, multi-client and service bureau research. In February 2001, the Company acquired the custom research group of Yankelovich Partners, a leading consultative marketing and opinion research firm.  Through its U.S. and Global Network offices, Harris Interactive conducts international research in multiple, localized languages. Harris Interactive currently maintains a database of more than 7 million online panelists -- the largest of its kind.  For more information about Harris Interactive, please visit the Company's website at http://www.harrisinteractive.com .

SOURCE Harris Interactive
http://www.harrisinteractive.com .