Author Topic: Risk evaluation & monitoring in MS therapeutics  (Read 129 times)

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Offline agate

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Risk evaluation & monitoring in MS therapeutics
« on: November 30, 2013, 08:04:56 pm »
From Sage Publications Multiple Sclerosis Journal, November 30, 2013:

Quote
Risk evaluation and monitoring in multiple sclerosis therapeutics

Michel C Clanet1
Jerry S Wolinsky2
Raymond J Ashton3
Hans-Peter Hartung4
Stephen C Reingold5

1Department of Neurosciences University Hospital Toulouse, France
2Department of Neurology, The University of Texas Health Science Center at Houston, USA
3AshtonMediCom, UK
4Department of Neurology and Center for Neuropsychiatry, Medical Faculty, Heinrich-Heine-Universitšt im UKD, Germany
5Scientific and Clinical Review Associates LLC, USA

Michel Clanet, Department of Neurosciences, PŰle Neurosciences CHU Toulouse Purpan Place Dr BAYLAC TSA 40031 31059 Toulouse Cedex 9, France. Email: michel.clanet@inserm.fr


Background:

 Risk for multiple sclerosis (MS) disease-modifying therapies (DMT) must be assessed on an ongoing basis. Early concerns regarding the first-approved DMTs for MS have been mitigated, but recently licensed therapies have been linked to possibly greater risks.

Objectives:

 The objective of this review is to discuss risk assessment in MS therapeutics based on an international workshop and comprehensive literature search and recommend strategies for risk assessment/monitoring.

Results:

Assessment and perception of therapeutic risks vary between patients, doctors and regulators. Acceptability of risk depends on the magnitude of risk and the demonstrated clinical benefits of any agent. Safety signals must be distinguishable from chance occurrences in a clinical trial and in long-term use of medications. Post-marketing research is crucial for assessing longer-term safety in large patient cohorts. Reporting of adverse events is becoming more proactive, allowing more rapid identification of risks. Communication about therapeutic risks and their relationship to clinical benefit must involve patients in shared decision making.

Conclusions:

It is difficult to produce a general risk-assessment algorithm for all MS therapies. Specific algorithms are required for each DMT in every treated-patient population. New and evolving risks must be evaluated and communicated rapidly to allow patients and physicians to be well informed and able to share treatment decisions.

The abstract can be seen here.

Note that the full article is available free. If you go to the link and look on the right side of the screen, you'll see a link to the complete article.

« Last Edit: May 31, 2016, 01:52:50 pm by agate »
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