1. Helping the people of Canada maintain and improve their health Aider les Canadiens et les Canadiennes à maintenir et à améliorer leur santé Health Canada’s Clinical Trials Database November 21, 2013 August 22, 2007 8:45-11:45 Banting Theatre Carole Légaré, MD Director, Office of Clinical Trials

2. 2 Health Canada’s Clinical Trials Database http://www.hc-sc.gc.ca/dhp- mps/prodpharma/databasdonclin/index-eng.php http://www.hc-sc.gc.ca/dhp- mps/prodpharma/databasdonclin/index-eng.php

3. 3 Plan Objective, Background Information provided by database, screen shots Characteristics of database Elements we have considered Consultations Limitations Clinical Trial completion

4. 4 Provide an overview of Health Canada’s Clinical Trial Database Information on Database Background What information can be found in the CT database How does it work - characteristics Limitations Study Termination Objectives

5. 5 Idea of a Health Canada clinical trial database is not new Consultation took place in 2005-2006 Never materialised- resources and regulatory concerns at the time Auditor General’s 2011 Fall Report recommended that “Health Canada should fulfill long-standing commitments to enhance public access to information on authorized clinical trials” The Standing Senate Committee on Social Affairs, Science and Technology therefore recommended in November 2012 that the Minister of Health “move to immediately require clinical trial registration to the greatest degree permitted under its existing legislative and regulatory authorities” Background

6. 6 Registration and disclosure considered a scientific, ethical and moral responsibility (WHO) Canada is behind other jurisdictions with their own registries (e.g., US, EU, Aus / NZ, Japan, China, Brazil, India), up until May 2013 there was no Canadian source of information for trials in patients 2012 survey showed only 50% of CTs authorised by Health Canada, from May 2011-2012, were registered in public registries Some journals require clinical trials to be registered for data to be published Background

7. 7 Information provided by the database: Medical condition Protocol title Drug name Sponsor’s name Study population Trial status Date of No Objection Letter (NOL) Study end date Study start date Protocol and control number

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11. 11 A listing of specific information relating to phase I, II and III clinical trials in patients Intent is to inform the public Not a registry: Information is limited - more administrative Database is prospective  Only CT that received an NOL from April 1 st, 2013 Information provided in both official languages Extracted from the DSTS (Drug Submission Tracking System) database (like the HC’s Drug Product Database) Searchable Limitations: Trial status Characteristics of the Database

12. 12 Elements we have considered: With exception of US and EU, phase I trials are being registered (WHO, ICMJE and CIHR policy; GSK, Lilly, BMS, Roche, Novo Nordisk) HC wants to protect the public from un-regulated trials With the exception of US, other countries ask for prospective registration Releasing information after the NOL is published is more in line with the objective of the database, which is to inform prior to patients enrolling Restricted Substances - Cocaine

13. 13 Notice and consultation with stakeholders: public, academia, industry, etc. Majority of Comments (73%) from healthcare professionals and academia/researchers Great majority thought that more information should be available Industry were concerned with IP and competitive information Included text within the Guidance for Clinical Trials Sponsors: Clinical Trial Application (Link: http://www.hc-sc.gc.ca/dhp- mps/prodpharma/applic-demande/guide-ld/clini/ctdcta_ctddec-eng.php)http://www.hc-sc.gc.ca/dhp- mps/prodpharma/applic-demande/guide-ld/clini/ctdcta_ctddec-eng.php Consultation

14. 14 We notice that for an important number (20-50%) of CTAs that received an NOL we did not receive a Clinical Trial Site Information (CTSI) form- Unknown if the trial has started Sponsor’s have an obligation under the regulations to submit CTSI forms when the trial is initiated at the site HC needs to be informed when there is a site closure When there is an amendment to a CTA, a CTSI form also need to be submitted confirming REB approval and other changes if applicable Important to know if a trial is ongoing when there are safety issues with a product under investigation Limitations of database

15. 15 Discontinuance of a trial at a site or its entirety needs to be reported within 15 days (C.05.015) A great number of sponsors do not report completion of trials Desirable to have information on the status of the trial In the context of new safety information where we need to know if a trial is ongoing With the new CT database this will avoid unnecessary enquiries on the CT status for sponsors Clinical Trial Completion

16. Contact Information Office of Clinical Trials Therapeutic Products Directorate Health Canada 1600 Scott Street Holland Cross, Tower B 5th Floor, Address Locator 3105A Ottawa, Ontario K1A 0K9, General Phone: 613-954-6493, Enquiries: oct_bec_enquiries@hc- sc.gc.ca Joël Raymond, Manager, Submission Management Division Phone: (613) 954-4922 email: joel.raymond@hc-sc.gc.ca 16