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Canadian Fabry Disease Initiative Study: Scientific Oversight |
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The Canadian Fabry Disease Initiative (CFDI) Study is being
conducted by a consortium of clinical researchers at five collaborating
centres across Canada. The objective of the CFDI
Study is to gather additional information regarding the use of enzyme
replacement therapies to treat patients suffering from Fabry Disease.
The CFDI Study is funded for three
years through a joint partnership of Health Canada, participating
provincial governments and the private sector. The Canadian Institutes
of Health Research (CIHR), as the Government of Canada's health
research funding agency, is responsible for administering the federal
funding to the CFDI Study.
CIHR and the Fonds de la recherche en santé du Québec (FRSQ) are
working with Health Canada and provincial governments to ensure that
the CFDI Study meets internationally accepted standards of scientific excellence. CIHR and FRSQ
arranged for international peer review of the Study at the proposal
stage and collaborated on the establishment of the Independent
Scientific Oversight Committee (ISOC) to monitor, evaluate and
communicate publicly the results of the research
More information about CFDI can be found on the CIHR website here:
http://www.cihr-irsc.gc.ca/e/35799.html
The Independent Scientific Oversight Committee (ISOC) will prepare an assessment of the CFDI Study, at least annually or as needed. The ISOC assessment will be based on the annual progress reports to be submitted by the CFDI research team, any ad hoc submission of proposed amendments to the Study protocol, and reviews of copies of the CFDI Study Data and Safety Monitoring Board reports.
ISOC assessment will include the following activities:
- monitoring the progress of the CFDI Study;
- assessing and ensuring the scientific validity of any interim data
and analyses included in Study progress reports for public release;
- assessing and ensuring the scientific validity of any proposed
changes to the Study protocol (particularly, but not exclusively, to
the eligibility criteria and/or the drug assigned to patients, or to
the dose eligible patients receive);
- taking into consideration any emerging ethical issues, including
safety of research participants (as reported by the Data and Safety
Monitoring Board); and
- reviewing research expense reports.
More information about the CFDI Terms of Reference is here:
http://www.cihr-irsc.gc.ca/e/35803.html#1
Information on the Scientific Oversight Committee is here:
http://www.cihr-irsc.gc.ca/e/35802.html
Other informative links:
http://clinicaltrials.gov/ct2/show/NCT00455104
http://communications.medicine.dal.ca/newsroom/fabry.htm
Under the CFDI study protocol, all Canadian Fabry disease patients meeting the criteria for treatment guidelines are eligible for the therapy. Guidelines can be found here:
http://www.garrod.ca/data/060613-1322-01.html
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