Oladayo Oyelola, PhD, SC (ASCP) Director, Clinical Trial Information Disclosure Daiichi Sankyo Pharma Development Edison, NJ 08837 Evolving Requirements For Posting Clinical Trial Information on the EudraCT and the EU Portal: Potential Impact on Demand CBI Clinical Data Disclosure and Transparency Philadelphia, PA. 18 & 19 January 2017
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Evolving Requirements For Posting Clinical Trial ...1).pdf · Evolving Requirements For Posting Clinical Trial Information on the EudraCT and the EU ... Form 3674 for US IND submissions
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clinical trial information disclosure.
Evolving EudraCT and EU Portal Requirements
3
Presentation Outline
Background and Timelines of Clinical Trial Information Disclosure
Overview of US and EU Clinical Trial Disclosure Regulations and Requirements
EMA Regulation (EU) No. 536/2014
New EU Portal and Database
EudraCT vs CT.gov (US) Data Elements
Evolving EudraCT and EU Portal Requirements
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Clinical Trial Disclosure Background & Timelines
Evolving EudraCT and EU Portal Requirements
1988/1997
US HOPE Act
/ FDAMA
2000
Clinical
Trials.gov
Launched
in US
2004/2005
ICMJE trial
registration
requirement for
publication
consideration.
EFPIA/IFPMA/
JPMA/PhRMA
Joint Position
Statement.
Other regional
and national
disclosure laws
2008 - 2010
EU Directives on
trial disclosures
Japan: MHLWNotification #415
Joint Position
revised
Joint Position of
Clinical Trial
Results in
Scientific
Literature
Other national
disclosure laws
2007
FDAAA
2011
EU-CTR.
2012
US disclosure of
results
notification
process during
informed consent
(in effect 2012)
US TEST Act
introduced to
expand
requirements (not
enacted)
2013
WMA’s Declaration of
Helsinki Revised
article 26
Alltrials Campaign
Launched
PhRMA / EFPIA’s
principles for
responsible data
sharing
EU Ombudsman’s
petition for access to
research data
2014
NIH proposals to
enhance transparency
of clinical trial results
TransCelerate
recommendation on
non promotional Lay
Summaries
EMA New Clinical
Trial Regulation –
Policy 0070
2015
IOM issues report on
sharing clinical trial
data
EMA Policy 0070 in
effect
WHO position
Statement on ethics
of publication and
data sharing
Good Pharma
Scorecard initiative
2016
EMA Policy 0070
Final Guidance
TransCelerate MRCT
white paper on return
of results to clinical
trial participants
(input from EMA /
FDA)
ICMJE data sharing
proposal for
publication
Open Knowledge:
Online database of
clinical trials
US White House
Cancer Moonshot
Initiative
Modified from TransCelerate BIOPHARMA INC
2017?
5
US Public Law 110-85: FDAAA/Final Rule (2007/2016)
Scope: Registration of clinical trials for Drugs & Medical devices
• Applicable to all Phase II to IV trials (Phase I trials are optional)
• ClinicalTrials.gov registry site launched in 1999
• Sponsors or PI submit information on registration system managed by the NIH
• Registration within 21 days of subject enrollment
• Standard statement on registration required in informed Consent forms
Study results data interface activated in 2007
• Results submission within 12 months of primary / study completion date
• Delayed submission may be approved, if
• certify seeking initial approval (new product license) or new use or new indication
Protocol registration & study results posting on ClinicalTrials.gov
• Registration certification, Form 3674 for US IND submissions
• FDA Compliance Program Guidance Manual - "Registration of Studies on ClinicalTrials.gov"
(Section D of Chapter 48)
Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting – Oct 2016
Evolving EudraCT and EU Portal Requirements
6
EU Trial Disclosure/Registration
EU Article 57(2) of Regulation (EC) No 726/2004
• Applies to adult trials within EU and third countries, if part of Paediatric Investigation Plan (PIP)
• Applicable to Phase II to IV trials + Phase I, if part of a PIP
Article 41(2) of Regulation (EC) No 1901/2006
• Applies to paediatrics trials within EU and third countries, if part of PIP
• Applicable to Phase I to IV trials
New EMA Regulation (EU) No. 536/2014
• Scope the same Art 41 and 52 - interventional clinical trials of medicinal products
• A new single EU portal and database planned to support:
• One application dossier for each clinical trial and/or modifications
• Coordinated approach to clinical trial authorization and supervision
• Transparency of clinical trial authorization, conduct and results
Study Protocol information registration site launched in March 2011
• EMA extracts and registers protocol information in EudraCT
• As submitted in the Clinical Trial Application (CTA) form before enrolment
• Direct disclosure on EU-CTR at the time of clinical trial authorisation
Evolving EudraCT and EU Portal Requirements
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EU Clinical Trial Disclosure Regulations
• Study Results data and information site launched in October 2013
• Scope covers all studies conducted in the EU or 3rd country, if part of PIP
• Studies in the EudraCT database from 2004 to date
• Compliance effective date is 21 July 2014
• Paediatric study results disclosure within 6 months of study completion – LSLV
• Adults study results disclosure within 12 months of study completion – LSLV
• Results of studies ending after date will be required as indicated above
• Results of studies that ended before July 2014, to be completed within 24 months
• Study data entry by Sponsor, Marketing Authorisation Holder, or
PIP addressee
• Applicable to all medicinal products - licensed/marketed and those
in development
Disclosure on EU-Clinical Trial Register - Clinicaltrialsregister.eu
Evolving EudraCT and EU Portal Requirements
8
Overview of EMA Policy - 0070
• The new policy will exist alongside the current access to documents policy
• The policy applies prospectively, it will not apply to legacy data submitted prior to the implementation of the policy
• Policy scope: clinical data submitted on/after the implementation date in relation to EU centralized procedure (CP) and article 58 applications (WHO).Does not apply to clinical data submitted for non-CP products.
• Clinical data: clinical reports and individual patient data (IPD)