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Highlights from ExL Pharma’s 5th Clinical Data Disclosure Summit
January 12-13, 2010
Washington, D.C.
Data Disclosure and TransparencyEuropean Requirements
Growing Public Interest in Transparency
Mandatory Israel Italy France Czech Republic Argentina South Africa China Taiwan Brazil India Netherlands Spain EU (Not yet implemented)
Proposed Croatia Switzerland Canada
Recommended Australia/NZ Germany Japan UK ISRCTN China Latin America Sri Lanka
Source: Adopted from June 2008 DIA meeting Pamela Rose presentation. Subject to changing legislation
For Regulators Eyes OnlyEudraCT: The European Clinical Trial Database
Created based on article 11 of Directive 2001/20 (“Clinical Trial Directive”)
Allows sharing of information by European health authorities (European Medicines Agency, Commission) on clinical trials
Provides for a unique trial identification number Access to regulators and EU Commission only Currently no direct data access by sponsors or
investigators EudraCT is currently a document management
system
How to Enter Information into EudraCT
Sponsor / investigator completes Trial Application Form and submits to participating NCA´s
Sponsor / Investigator requests EudraCT Nr.,
EudraCT
NCA´s, Commission*
*NCA: National Regulatory Authority** Drug Safety, Investigational Products, Approved Products
NCA´s*
Other Dbs**
EudraCT is ChangingNew features coming up
From version 8 EudraCT will be changed from a document storage to a true relational database
XML schema publicly accessible Will provide for multi-language fields Version 8 to go public Q2 2010
Public access to protocol information for ongoing and completed clinical trials (adult and paediatric)
Will be linked to EudraPharm for marketed products Version 9 release not yet defined (end 2010?)
Public access to clinical trial results (adult and pediatric, approved and investigational)
Making EudraCT Fit For for the PublicA Challenging Undertaking
Public Access Which information: Data fields, protection of confidential data,
languages When to release: Before / after trial start, Ethics Committee
vote How to access: Search engine, link to other registers and
portals Results
Which information and how: format, data fields Data Quality: Consistency with other result information (eg
FDAAA) Third Country Trials
EudraCT number for non-EU trials Link to EudraVigilance and Investigational Products database
Some Specific ChallengesTrial Registration
Registration in EudraCT is part of the trial application process which is a national process
Protocols for the same trial may differ between different countries (“local amendments”)
Some EU countries require all or part of the application in local language
For Trial Portals (e.g. IFPMA, WHO) and quality assurance: Which protocol version is the reference version?
Some Specific ChallengesRelease of Information to the Public
Release to information from EudraCT to the public will be triggered automatically once the trial is approved Trial may not start for significant time or not at all Reasons for Ethic Committee rejection will be made public Protocol may undergo numerous amendments before final
start Quality and consistency of information between
different EU countries and with non-EU registers for global trials For trial designs For result information
Creation of a search engine capable of handling multiple languages
Some Specific ChallengesThird Country Trials
Trials exclusively running outside of the EU do not normally require a EU trial application and no EudraCT number but have to be included in EudraCT when part of a paediatric investigation plan (PIP) Specific process for EudraCT number application Cannot be handled by National authorities Direct access necessary to EudraCT by international
sponsors / investigators Adverse drug experience from non-EU trials to be
entered into European Pharmacovigilance database Investigational Product database to capture non-EU
approved comparators
Developing Data Standards
The European Medicines Agency joined the CDSC and HL7 consortia
Objective is to harmonize electronic data definition standards for health related data on an internationally Study protocols Electronic health data Public health databases Etc
Common data definition standards should ease data exchange and maintain data quality
Transparency in Clinical TrialsWhat is Different in Europe Compared to US?
EU Pediatric Regulation
EU Regulation 726/2004
FDAAA
Scope All interventional studies Phases 2-4 Phase 2-4
Process Submission of information as part of the trial application process
Data entered by authorities
As paediatrics Submission of information independent of trial applicationData entered by applicant
Release Data automatically released after trial approval or rejection
As paediatrics Data release triggered by applicant
Language All official EU languages As paediatrics English
Versions One per participating country As paediatrics Single version
Scope All information currently in EudraCT wil be made publicly accessible
Only information defined by chapter 8
The Clinical Trials Registry- India (CTRI)
New Mandatory Registration: Overcoming the Hurdles and Best Practices for Compliant Registration with India’s Clinical Trials Registry
Increasing clinical trial flow to India is a result of several fundamental strengths
0 5 10
Cancer
Diabetes
HIV
Epilepsy
Hypertension
Schizophrenia
Asthma
Alzheimer's
Cardiac Deaths
• Large patient populations with
diseases of both developed &
developing world
• Competent medical
professionals
• Site infrastructure
• Potential for cost & time
savings
• Likely high growth market in
future
India has a large patient pool in diabetes, cardiovascular disease
HIV and Oncology.
Source: National Commission on Macroeconomics and Health , Ministry of Health &
Family Welfare, Government of India, New Delhi, September 2005
Mio Patients
40
34
150
India - the highest # of protocols and sites in AsiaBut still relatively limited number…
India- 2009 Clinical Study Start Up times
Time ( weeks)
TOTAL* 18-22 weeks
* Review time includes Export License approval
• No import duty on clinical trial supplies2003
Exemption from registration requirements for CTS 2003 Amendments to Schedule Y 2005
Export of biological specimens 2005
Exemption from Service Tax on new drug testing 2007
Need for export license (blood products) waived 2009
Mandatory registration of interventional Clinical Trials 2009
Key Regulatory milestones
Clinical Trials Registry - India
Set up by ICMR’s NIMS To encourage all registration of clinical trials prior to patient
enrolment Full disclosure of all WHO mandated items To improve transparency and accountability Improve internal validity Conform to accepted ethical standards Lead to reporting of all relevant results of all CTs in India and
the region
Registration of all clinical trials prospectively
Voluntary disclosure of all items in the register
To improve transparency
To improve internal validity of trials
Conform to accepted ethical standards
CTRI Vision
Encourage all clinical trials to be prospectively registered before enrolment of first patient
To comply with ICMJE and WHO-ICTRP requirements
CTRI Mission
Who is responsible for registering a trial?
Principle Investigator (PI) or the Primary Sponsor
For Multi-Centric and Multi-Sponsor Trials, it is the lead PI or lead Sponsor should take responsibility for registration.
In case of Multi-Country Trials, the Indian PI should also get the trial registered in CTRI quoting any other Registration number as its Secondary ID.
Internet
NIMS Campus
1. The NIMS Pilot CT Registry Portal will be hosted on the Internet 2. Responsible Registrants can register the details of the clinical trials directly on the portal3. Interested parties/general public can directly search for information on the registry.
Responsible Registrants
Leased Line to Internet(to be provided by NIMS)
Public/Interested parties
Pilot Implementation Server(to be provided by NIMS)
Firewall(to be provided by NIMS)
Layout of the Registry
Still have any questions? For additional information on ExL Pharma’s Clinical Data Disclosure Summits, please visit www.exlpharma.com