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Managing global regulatory complexityClinical trial transparency, reporting and real-time data driven compliance
August 14, 2019
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Speakers• History and overview of clinical trial disclosure
• Global perspectives on disclosure• Challenges in regulations and changing environments
• Best practices for improving efficiencies and harmonization
• Role of technology
• Summary
Today’s discussion
April Hernandez, MScRegulatory Consultant, Life SciencesClarivate Analytics
Teresa FishburneGlobal Practice Leader, Clinical and Regulatory Consulting ServicesClarivate Analytics
Robert A. PaarlbergPrincipalPaarlberg & Associates LLC
Overview of the clinical trial disclosure and transparency landscape
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Key disclosure/transparency milestones
1997 2000 2001 2005 2007 2009/11 2014 2015/16 2018 2019
FDAMA 113(11/97)
CT.gov database launched (2/00)
EU Clinical Trials Directive 2001/20/EC(4/01)
FDAAA 801(9/07)
CT.gov Results Reporting
(9/09)
EU Clinical Trial Regulation(4/14)
EudraCT Results Reporting(7/14)
NIH Final Rule (9/16)
EU Clinical Trial Information System (est. 4Q20)
Lay Summaries Mandated(est. 4Q22)
Health Canada PublicRelease of Clinical
Information (3/19)
ICMJE – Data Sharing Plan
(1/19) ICMJE - Data Sharing
Statement(7/18)
EMA Policy 0043(11/10)
FDA ‘CSR Pilot’ (1/18)
U.S. Transparency Initiatives
EU Transparency Initiatives
Canada Transparency Initiatives
ICMJE Policies
EMA Policy 0070(1/15)
ICMJE –Registration Requirement
(7/05)
2020 2020+
EU Clinical Trial Register Launched(3/11)
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Clinical trial disclosure continuumDuring the lifecycle of a clinical trial these core documents must be disclosed
EMA Publication
Website
Disclosed on ClinicalTrials.gov
Journal Publications
Health Authorities
Scientific Congresses
Disclosed on
EudraCT
Study Protocol
Statistical Analysis
Plan
Clinical Study Information & Updates
Clinical Study
Report
Clinical Study
Results Data
Affiliates/CROs prepare CTAs
Lay Summaries
Country Registries
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Clinical data flow
*The Protocol, SAP, and all Global Protocol Amendments must all be included as part of the Summary Results Posting for ClinicalTrials.gov.
Protocol *
Narratives
SAP*
PublicationsPlanning
Journals
Scientific Symposium
Presentations
Protocol Registration
Protocol Amendments*
Summary Results Posting
Lay Summary
Publications
Clinical Development/ Regulatory Process
Clinical Trial Transparency
TLGs
Common Technical
Document
Posters
Redacted & Anonymized Clinical
Data
Clinical Study Report
Data Sharing Data Sharing Requests
Patient Level Data
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Who is looking at ‘your’ data?Clinical trial disclosure stakeholders
Patients
‘Transparency Watchdogs’
(e.g., FDAAA/EU Trials Tracker, AllTrials,
Bioethics International)
Financial Community
Competitive Analysis
CompaniesCompetitors
Academic Researchers
Plaintiff Attorneys
Third Party PayersJournal Editors
Healthcare Practitioners
Challenges in regulations and changing environments
Poll question:What do YOU view as the top challenge of clinical trial reporting harmonization?
A. Individual country registry requiring data at varying points in time and different data sets
B. Lack of standardization in the way data is captured and reported
C. Locally compliant reported data from in-country teams not aligned with data publicly available in other countries
D. The need for a central place where trial sponsors and their local affiliates are tracking what is being disclosed, when it’s being disclosed, and where it’s being disclosed
• Customized solution allowed top 20 pharma to:
– Confidently plan global strategy for clinical trial development and registration
– Streamline data entry requirements by syncing timelines
– Ensure regulatory compliance for clinical trials in all applicable markets
– Clarify responsible parties for information entry into registries and source of information (e.g., CTA, Direct from Source)
Case study A solution to these challenges
The Lebanese Ministry of Public HealthChallenges in regulations and changing environments
• Developed a mandatory clinical trial registry • Studies must be registered prospectively and must be
completed before the recruitment of the first patient/subject• Responsible parties must register and submit summary results
of investigational clinical trials– Applies to all interventional trials of drugs, biologics, and
medical devices
– Registration is optional for observational studies but highly recommended
• An official decree has not published, but is considered to be a WHO Primary Registry
• The Plataforma Brasil is a Brazilian unified database containing research projects involving human beings, developed to support the CEP/CONEP System analysis and monitoring follow-up.
• Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clínicos(ReBEC)) is a joint project of the Brazilian Ministry of Health, Pan American Health Organization (PAHO) and Oswaldo Cruz Foundation (FIOCRUZ).
• Registration is mandatory and Brazilian Clinical Trials Registry (ReBec) is part of the International Clinical Trials Registry Platform (ICTRP) registry network.
• In order to hold a clinical study in Brazil, sponsor must provide proof of registration.
• The Brazilian Ministry of Health published Circular 189/2017/CONEP/CNS/MS: Registry of Clinical Research Protocols in the Brazil Platform, 16-May-2017, which mandated trials be published in the Platform and no more paper would be allowed by 2018.
Brazilian Ministry of HealthChallenges in regulations and changing environments
• Aim is to ensure that a complete view of research is accessible to all those involved in health care decision making to improve research transparency and strengthen the validity and value of the scientific evidence base
• An individual company cannot register a trial with WHO• Platform consists of Primary Registries, Partner Registries
and Data Partners • WHO is a driver in the development of some of the smaller
country clinical trial registries, adding to the network of globally available information
WHO International Clinical Trials Registry PlatformChallenges in regulations and changing environments
Best practices for improving efficiencies and harmonization
Monitor the landscapefor changes andpotential issues
Conduct in-depth analysis to inform
R&D activities
Keep all departments informed and on top of
regulatory changes
Establish a transparency steering
committee
Role of technology
Poll question:What do YOU view as the MOST beneficial way technology can simplify clinical trial transparency and reporting?
A. Streamline communication and ensure that users are informed of new regulations and their impact in a timely manner
B. Empower your teams to reference the most current information and remain compliant
C. Reduce risk of non-compliance and of time and resources spent searching for the most up to date information
D. Can’t choose, all of the above are necessary
• Enables regular intelligence updates to ensure your teams are referencing most current information and remain compliant
• Provides a bird’s eye view of changes and allows you to drill into detail to allow for flexible review of intelligence
• Delivers impact analysis, full history of activity, and status changes to better monitor performance
Optimal solutions should meet these criteria
Role of technology
Increase accuracy, speed and productivity
• Notify teams of new assignments and manage their workload through task management and collaboration tools
• Utilize notifications to streamline communication and ensure that users are informed of new regulations and their impact in a timely manner
• Leverage activity reporting to measure performance over time and identify areas for improvement
Benefits of technology
Optimize Collaborate Reduce risk Streamline
Leverage technology to prioritize tasks and remain compliant
Drive efficiencies by utilizing a single point of customized regular updates that fits seamlessly into existing workflows
Quickly communicate changes, updates and alerts with others across all functional areas to ensure consistency
Increase transparency through organized monitoring and prioritization to draw attention to immediate actions
Reduce time and resources spent on searching for information and expertise – instead, monitor performance
Join us for an exclusive virtual event on October 16th!
Register now! http://bit.ly/CortellisSimplifyGlobalComplexity
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