Health Canada Plans "web-based list" of authorized Canadian clinical trials

I sent John Duncan, local MP, some questions re the Oct. 18th HC announcement. Below is the response I received from his Constituency Representative Rita Hatfield
:

---- Original Message ----- From: <john.duncan.c1@parl.gc.ca>
To: <pmmaddocks@shaw.ca>
Sent: Friday, November 23, 2012 6:47 PM
Subject: RE: Today's Press Release


Pat,

My apologies for the delay in getting back to you.

I forwarded your emails, questions and website information to the MP Caucus Liason for Helath Canada and received the following information regarding the Canadian List of Authorized Clinical Trials:

The publication of a web-based list of authorized Canadian clinical trials is a first step towards improving transparency for patients searching for what trials are available in Canada.

•The list is not a registry and will not replace international registries that currently exist; it will be a Canada-based administrative list that is easily found and searchable.

•Health Canada continues to encourage sponsors to register their clinical trials and publish their clinical trial results in existing public registries. Health Canada’s list will complement the disclosure of comprehensive information by sponsors in such public registries.

•The list is being developed to assist patients to independently confirm if a trial that he/she is considering to enrol in, has been authorized.

•The initial scope of the list will focus on drugs that are in early phases of human clinical trials ( Phases I-III), and not in trials in healthy volunteers or trials involving drugs that are already approved (Phase IV) where Health Canada authorization is not required. Other health products such as medical devices are not included at this time.

•Although the information to be published in the list will be provided by clinical trial sponsors and such information is not subject to the Official Languages Act, Health Canada plans to publish the list in both official languages.

•Incoming enquiries or requests should be directed to Dr. Celia Lourenco, Acting Director of the Office of Clinical Trials, Therapeutic Product’s Directorate. (celia.lourenco@hc-sc.gc.ca).

I know the information does not answer all of your questions and would encourage you to contact Dr. Lourenco for further clarification.

I will be sure Minister Duncan is made aware of the correspondence received. Please do not hesitate to let me know if we can be of further assistance.

Sincerely,
Rita Hatfield
Constituency Representative

Hon. John Duncan, PC, MP
Vancouver Island North
Minister of Aboriginal Affairs and Northern Development
Ph: 250-338-9381
Fax: 250-338-9361
Toll Free 1-800-667-8404