New Migraine Medication Clinical Trial Guidelines Published
Do you ever wonder how clinical trials for Migraine medications are designed and set up? When we stop and think about it, without some kind of guidelines, there would be a free-for-all with trials differing so much that the results would be rendered useless. Yes, we have the FDA and various agencies to govern them, but how can those agencies possibly know what's best for all the various types of medications? Plus, our agencies have no authority in other countries, and clinical trials conducted in other countries often impact research in the United States.
Just as health care professionals generally turn to the International Headache Society (IHS) for diagnosing Migraine and other headache disorders by using their International Classification of Headache Disorders, Second Edition (ICHD-II), researchers turn to IHS guidelines for setting up and conducting clinical trials for Migraine medications.
Yesterday, the IHS released "Guidelines for controlled trials of drugs in migraine: Third edition. A guide for investigators." The new guidelines represent an expert consensus summary, and recommend a contemporary, standardized, and evidence-based approach to investigators conducting and reporting randomized, controlled Migraine clinical trials.
Migraine clinical research has increased exponentially since the last set of guidelines was published. Clinical researchers and pharmaceutical companies have accumulated further experience, and the trend is towards large, multi-national and multi-center studies. Given these developments, it was timely to bring the guidelines up to date.
The IHS stresses that it endorses adherence to the guidelines unless there is scientific justification to deviate from them. They represent research practice parameters and are the highest level in the hierarchy of evidence-based recommendations in the absence of published standards of research practice.
Trials for acute Migraine (medications taken when a Migraine occurs) are addressed in the new guidelines' first section, followed by discussions and recommendations relating to clinical trials for Migraine prevention. This includes short-term prevention or 'mini-prophylaxis' for predictable Migraine attacks, such as those associated with a woman's menstrual cycle. Sub-sections include:
- patient selection,
- trial design,
- evaluation of results and statistics.
A toolbox for each type of trial (acute and prevention) is provided at the end.
The guidelines do not include broader discussions of clinical trials methodologies or ethical considerations, which are published elsewhere.
The publication supersedes previous guidelines. The first edition, published by the Clinical Trials Subcommittee of the IHS in 1991, highlighted the complex nature of Migraine clinical trial methodologies and offered a road map to clinical investigators who were interested in the field. Widely adopted, these guidelines were the impetus for similar guidelines' development for tension-type headache and cluster headaches as well. A second edition was published in 2000 and formed the basis for the European Medicines Agency's 2007 publication, Guidelines on Clinical Investigation of Medicinal Products for the Treatment of Migraine.
Freedom from pain as the primary measure of treatment efficacy is gaining ground in clinical trials today.
International Headache Society Clinical Trials Subcommittee. "Guidelines for controlled trials of drugs in migraine: Third edition. A guide for investigators." Cephalalgia 2012 32: 6. DOI: 10.1177/0333102411417901.
Press Release. "New migraine clinical trial guidelines." Los Angeles. Sage Publications. January 24, 2012.
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