Regulatory Focus™ > News Articles > Health Canada Launching Clinical Trials Transparency Database

Health Canada Launching Clinical Trials Transparency Database

Posted 29 April 2013 | By Alexander Gaffney, RAC

Health Canada will soon make public key information on clinical trials conducted by industry in the country, introducing a measure of transparency that is ultimately meant as a half-step toward still greater measures.

The 26 April 2013 statement explains that Health Canada is informing all clinical trials sponsors that essential data on pharmaceutical trials will be published starting in May 2013, "and will include trials that were issued a No-Objection-Letter (NOL) as of 1 April 2013."

The information released will include the sponsor's protocol number, the protocol title, the drug name, the medical condition for which it is being studied, the drug's authorization date, the trial sponsor's name, the control number for the trial, and the start/end date for the trial.

The move is not unexpected, with Health Canada announcing the change in December 2012. At the time, it was envisioned that the database would be launched in April 2013-a month earlier than its current planned launch date.

As Regulatory Focusexplained at the time, the database is also seen as an interim measure before a formal Canadian trial registry can be implemented. Those plans remain under consideration.

All known phase I, II or III clinical trials will have their basic information included in the registry, and information will be updated on a daily basis.

The information would put the database in line with much of the information publicly released in the US under the ClinicalTrials.gov database, but would fall well short of the transparency initiatives being called for by EU regulators, who have called for all anonymized patient-level data to be made publicly available.



Health Canada: Notice - Publication of information about certain Clinical Trial Applications authorized by Health Canada


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