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gust 22, 2007 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 Carole Légaré, MD Director, Office of Clinical Trials Health Canada’s Clinical Trials Database http://www.hc-sc.gc.ca/dhpmps/prodpharma/databasdonclin/index-eng.php 2 Plan • • • • • • • Objective, Background Information provided by database, screen shots Characteristics of database Elements we have considered Consultations Limitations Clinical Trial completion 3 Objectives • 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 4 Background • 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” 5 Background • 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 6 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 7 10 Characteristics of the Database • 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 1st, 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 11 Restricted Substances - Cocaine 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 12 Consultation • 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/dhpmps/prodpharma/applic-demande/guide-ld/clini/ctdcta_ctddec-eng.php) 13 Limitations of database • 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) formUnknown 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 14 Clinical Trial Completion • 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 15 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: [email protected] • Joël Raymond, Manager, Submission Management Division Phone: (613) 954-4922 email: [email protected] 16