The goal of the Canadian Migraine Forum was to work towards improving the lives of Canadians with migraine by reducing their migraine-related disability. This paper reviews the epidemiology and diagnosis of migraine, and the effects of migraine on health related quality of life. Many patients with migraine do not consult a physician for their headaches, and when they do they often do not receive a correct diagnosis. The discussion at the Forum concluded that better education, both for physicians and the public, on issues relating to migraine was a necessary step in improving migraine diagnosis. The degree of disability caused by migraine is often not recognized by society, and can be substantial for individuals with migraine. Once again, education of the public and of the health professionals who see these patients is key, so that the best migraine management can be instituted to minimize the impact of migraine on the individual, the family, and society at large.

The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context- based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what “authorization to market a drug in Canada” means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to the drug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues.

In the past two decades there has been a tremendous effort among clinicians and searchers to improve the diagnostic criteria of the dementias on the basis of the differential neurological and neuropsychological profiles. This was an obligatory requirement for clinical trials and the development of treatments. Over the years it became rapidly evident that the cohorts of patients in studies had some degree of heterogeneity, making it difficult to interpret the results of some studies, particularly in the vascular dementias and the mild cognitive impairment (MCI) group. For example, many sub-types of the vascular group were included in clinical trials, such as the cortical strokes, the lacunar states and the diffuse white matter disease cases, and some of the patients might have had also mixed pathology. In addition, the standard DSM IV criteria for dementia no longer represent our present knowledge of the clinical profile of some of the dementias such as vascular dementia (VaD) and fronto-temporal dementia where the memory impairment is not necessarily the first requirement. To improve the validity of clinical trials and eventually help developing more appropriate treatments, we revised the present diagnostic criteria and made recommendations for some changes in the context of the 2nd Canadian Conference on the Development of Antidementia Therapies, held in 2004 and reviewed in the light of the recent literature as of early 2006. It is expected that in the near future, these dementia criteria for clinical trials will have to be revised again in order to include specific subtypes of the dementias as well as biomarkers, structural and functional imaging.

The purpose of this paper is to discuss both normal perivascular spaces (PVSs) and pathological giant perivascular spaces (GPVSs). The anatomy and physiology of normal PVSs, including important immunological and lymphatic roles, are described. Special attention is given to the Magnetic Resonance Imaging (MRI) findings of both normal and GPVSs. Furthermore, the clinical features and pathogenesis of GPVSs are explored, with special emphasis on the pathological implications of these lesions, and their relevance. It is important that symptomatic GPVSs not be mistaken for more devastating disease processes. When the lesions in question occur in a characteristic location along the path of a penetrating vessel, are isointense with cerebrospinal fluid on all MRI sequences, do not enhance with contrast material, are not calcified, and have normal adjacent brain parenchyma, their appearance is pathognomonic of GPVSs. The clinician should realize that an extensive differential diagnosis is superfluous and that biopsy is unnecessary in these patients. Instead, the clinical focus should be aimed at neurosurgical intervention, as dictated by the symptoms of mass effect.

Magnetic resonance imaging (MRI) procedures have been used for over 20 years. This modality is considered relatively safe and holds great promise. Yet, MRI has a number of risks. In order for MRI research to meet the Canadian standard of disclosure, the investigator must communicate and make note of all risks in their research protocols and consent forms. Those creating and reviewing research protocols and consent forms must take notice of the different circumstances under which MRI poses a risk. First, this paper will describe the current standard of disclosure in Canada for research participants. Second, the paper will provide a comprehensive synthesis of the known physical and psychological risks associated with MRI. Third, the paper will provide recommendations concerning areas for further investigation and risk reduction strategies. This information will thus equip researchers and research ethics boards (REBs) with the criteria needed for the composition of research protocols that meet the Canadian disclosure standard.