Speech (House debate)

{
    "time": "2013-12-03 10:10:00",
    "attribution": {
        "en": "Hon. Rona Ambrose (Minister of Health, CPC)",
        "fr": "L'hon. Rona Ambrose (ministre de la Sant\u00e9, PCC)"
    },
    "content": {
        "en": "<p data-HoCid=\"3505369\">Mr. Speaker, with regard to milestones and the reporting process in the Canadian MS clinical trial supported by the Canadian Institutes of Health Research as queried in questions (a), (b), (c), (d), (n), and (r), the Canadian MS clinical trial supported by the Government of Canada is taking place in four sites across the country: Vancouver, Winnipeg, Montreal, and Quebec City. The trial led by Dr. Anthony Traboulsee from the University of British Columbia started on November 1, 2012; two sites, Vancouver and Montreal, received ethics approval in 2012, and the other two sites received ethics approval from their research institutions by February 2013.</p>\n<p data-HoCid=\"3505370\">The four teams have met on a regular basis to ensure harmonization of the protocol among the sites. Protocol training, ultrasound technician training, and interventional radiologist training took place at the four sites over the course of 2013 and were completed by September 2013. </p>\n<p data-HoCid=\"3505371\">The recruitment of patients has started at the four sites and is expected to be completed over the next year. In all, 100 patients are expected to participate in the trial.</p>\n<p data-HoCid=\"3505372\">In August 2013, Dr. Traboulsee announced that researchers had been able to assess approximately 50 patients to determine whether they have the CCSVI condition and that procedures had been done on fewer than 10 patients.</p>\n<p data-HoCid=\"3505373\">It is important to note that the study is a double-blind study. In other words, neither the subjects of the experiment nor the persons administering the experiment know the critical aspects of the experiment. This process is important, as it guards against both experimenter bias and placebo effects. In this context, the researcher team will be unable to analyze and share preliminary data before the study is completed. </p>\n<p data-HoCid=\"3505374\">Dr. Traboulsee expects to reach final conclusions on the safety and efficacy of the CCSVI procedure by 2016. It is expected that the results of this study will be published in peer-reviewed journals. Under CIHR\u2019s open access policy, researchers awarded CIHR funding are required to ensure that all research papers generated from CIHR-funded projects are freely accessible through the publisher's website or an online repository within 12 months of publication. </p>\n<p data-HoCid=\"3505375\">As indicated in the request for applications, the principal investigator will have to submit a final report to CIHR. He is also required to submit annual progress reports. </p>\n<p data-HoCid=\"3505376\">With regard to the protocol and funding of the MS clinical trial as queried in questions (e), (f), (g), (h), (i), (j), (k), (l), (m), (o), (p), and (q), funding of the $6 million study over four years is a collaborative effort of CIHR, the MS Society of Canada, and the provinces in which the trial will take place. The Provinces of British Columbia, Manitoba, and Qu\u00e9bec and the MS Society of Canada have each pledged $500,000 towards this clinical trial.</p>\n<p data-HoCid=\"3505377\">Details regarding the funding opportunity developed by CIHR to support a phase I/II MS clinical trial, including the selection criteria, are available on CIHR\u2019s website. </p>\n<p data-HoCid=\"3505378\">The proposals submitted to CIHR for the funding opportunity were rigorously evaluated by a panel of international experts. The panel recommended supporting the application submitted by Dr. Anthony Traboulsee, which ranked first in the competition. </p>\n<p data-HoCid=\"3505379\">It is important to note that all of the 100 MS patients participating in the trial will receive the CCSVI procedure at some point. During the first year of the trial, half of the patients will receive the CCSVI procedure, while the other half will undergo a placebo procedure. In the second year, MS patients who received the placebo procedure in the first year will undergo the CCSVI procedure, while those that received the CCSVI procedure in the first year will undergo the placebo procedure. MS patients participating in the double-blind clinical trial will be monitored over a two-year period. Specific questions regarding the protocol of this independent research project or the cost of the clinical procedures should be addressed directly to the principal investigator of the study.</p>",
        "fr": "<p data-HoCid=\"3505369\">Monsieur le Pr\u00e9sident, en r\u00e9ponse aux parties a), b), c), d) n) et r) de la question, la SP, l\u2019essai clinique canadien sur la scl\u00e9rose en plaques, la SP, appuy\u00e9 par le gouvernement du Canada, a cours \u00e0 quatre centres du pays, soit \u00e0 Vancouver, \u00e0 Winnipeg, \u00e0 Montr\u00e9al et \u00e0 Qu\u00e9bec. Cet essai, men\u00e9 par le Dr Anthony Traboulsee de l\u2019Universit\u00e9 de la Colombie-Britannique, a d\u00e9but\u00e9 le 1er novembre 2012. Deux centres, ceux de Vancouver et de Montr\u00e9al, ont re\u00e7u l\u2019approbation \u00e9thique n\u00e9cessaire en 2012. Les deux autres ont re\u00e7u l'approbation \u00e9thique de leur \u00e9tablissement de recherche en f\u00e9vrier 2013.</p>\n<p data-HoCid=\"3505370\">Les quatre \u00e9quipes se sont r\u00e9unies sur une base r\u00e9guli\u00e8re pour assurer l\u2019harmonisation du protocole dans tous les centres. De la formation sur le protocole, ainsi que de la formation destin\u00e9e aux techniciens en \u00e9chographie et aux radiologistes d\u2019intervention, a \u00e9t\u00e9 offerte aux quatre centres jusqu\u2019au mois de septembre 2013.</p>\n<p data-HoCid=\"3505371\">Le recrutement des patients a d\u00e9but\u00e9 aux quatre centres et devrait se terminer au cours de la prochaine ann\u00e9e. En tout, une centaine de patients devraient participer \u00e0 l\u2019essai.</p>\n<p data-HoCid=\"3505372\">En ao\u00fbt 2013, le Dr Traboulsee a annonc\u00e9 que les chercheurs avaient r\u00e9ussi \u00e0 \u00e9valuer environ 50 patients afin de d\u00e9terminer s'ils pr\u00e9sentaient une insuffisance veineuse c\u00e9phalorachidienne chronique, une IVCC, et que moins de 10 patients avaient subi une intervention pour la traiter. </p>\n<p data-HoCid=\"3505373\">Il importe de noter qu\u2019il s\u2019agit d\u2019une \u00e9tude \u00e0 double insu. Autrement dit, ni les sujets de l\u2019exp\u00e9rience ni les personnes qui proc\u00e8dent \u00e0 l\u2019exp\u00e9rience ne connaissent les aspects critiques de cette derni\u00e8re. Cette fa\u00e7on de proc\u00e9der est importante parce qu\u2019elle \u00e9vite le parti pris de l\u2019exp\u00e9rimentateur et les effets placebo. L\u2019\u00e9quipe de recherche ne sera donc pas en mesure d\u2019analyser et de communiquer les donn\u00e9es pr\u00e9liminaires avant la fin de l\u2019\u00e9tude. </p>\n<p data-HoCid=\"3505374\">Le Dr Traboulsee pr\u00e9voit en arriver \u00e0 une conclusion finale sur la s\u00e9curit\u00e9 et l\u2019efficacit\u00e9 de l\u2019intervention contre l\u2019IVCC d\u2019ici 2016. Les r\u00e9sultats de l\u2019\u00e9tude devraient \u00eatre publi\u00e9s dans des revues \u00e0 comit\u00e9 de lecture. Conform\u00e9ment \u00e0 la Politique de libre acc\u00e8s des IRSC, les chercheurs qui re\u00e7oivent du financement des IRSC sont tenus de s\u2019assurer que tous les articles de recherche d\u00e9coulant de projets financ\u00e9s par les IRSC sont rendus librement accessibles dans le site Web de l\u2019\u00e9diteur ou un d\u00e9p\u00f4t en ligne dans les 12 mois suivant leur publication. </p>\n<p data-HoCid=\"3505375\">Comme cela est pr\u00e9cis\u00e9 dans l\u2019appel de demandes, le chercheur principal doit soumettre un rapport final aux IRSC, en plus de rapports d'\u00e9tape annuels. </p>\n<p data-HoCid=\"3505376\">Enfin, pour ce qui est des parties e), f), g), h), i), j), k), l), m), o), p) et q) de la question, le financement de six millions de dollars sur quatre ans consacr\u00e9 \u00e0 cette \u00e9tude s\u2019av\u00e8re un effort concert\u00e9 des IRSC, de la Soci\u00e9t\u00e9 canadienne de la SP et des provinces o\u00f9 se d\u00e9roulera l\u2019essai. Les provinces de la Colombie-Britannique, du Manitoba et du Qu\u00e9bec, ainsi que la Soci\u00e9t\u00e9 canadienne de la scl\u00e9rose en plaques, se sont d\u00e9j\u00e0 engag\u00e9es \u00e0 verser 500 000 $ chacune pour la r\u00e9alisation de cet essai clinique. </p>\n<p data-HoCid=\"3505377\">On peut obtenir de plus amples renseignements sur la possibilit\u00e9 de financement lanc\u00e9e par les IRSC afin d\u2019appuyer l\u2019essai clinique sur la SP de phase I/II, y compris les crit\u00e8res de s\u00e9lection, dans le site Web des IRSC.</p>\n<p data-HoCid=\"3505378\">Les propositions pr\u00e9sent\u00e9es aux IRSC dans le cadre de la possibilit\u00e9 de financement ont \u00e9t\u00e9 soumise \u00e0 une \u00e9valuation rigoureuse d\u2019un comit\u00e9 d\u2019experts internationaux. Ce comit\u00e9 a recommand\u00e9 d\u2019appuyer la demande du Dr Anthony Traboulsee, qui s\u2019est class\u00e9e premi\u00e8re lors du concours. </p>\n<p data-HoCid=\"3505379\">Il importe de noter que la centaine de personnes atteintes de SP qui participent \u00e0 l\u2019essai vont toutes subir une intervention contre l\u2019IVCC. La premi\u00e8re ann\u00e9e, la moiti\u00e9 des patients subiront l\u2019intervention, tandis que l\u2019autre moiti\u00e9 subira une intervention fictive. La deuxi\u00e8me ann\u00e9e de l\u2019essai, les patients qui auront subi l\u2019intervention fictive la premi\u00e8re ann\u00e9e subiront l\u2019intervention contre l\u2019IVCC, et vice versa. Les personnes atteintes de SP prenant part \u00e0 l\u2019essai \u00e0 double insu seront suivies pendant deux ans. Toute question pr\u00e9cise au sujet du protocole de ce projet de recherche ind\u00e9pendant ou du co\u00fbt des interventions cliniques devrait \u00eatre adress\u00e9e directement au chercheur principal de l\u2019\u00e9tude. </p>"
    },
    "url": "/debates/2013/12/3/rona-ambrose-1/",
    "politician_url": "/politicians/rona-ambrose/",
    "politician_membership_url": "/politicians/memberships/1250/",
    "procedural": false,
    "source_id": "p3505369",
    "h1": {
        "en": "Routine Proceedings",
        "fr": "Affaires Courantes"
    },
    "h2": {
        "en": "Questions on the Order Paper",
        "fr": "Questions au Feuilleton"
    },
    "h3": {
        "en": "Question No. 53",
        "fr": "Question no 53"
    },
    "document_url": "/debates/2013/12/3/",
    "related": {
        "document_speeches_url": "/speeches/?document=%2Fdebates%2F2013%2F12%2F3%2F"
    }
}