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Managing global regulatory complexity Clinical trial transparency, reporting and real-time data driven compliance August 14, 2019
Today’s discussion • History and overview of clinical trial disclosure Speakers • Global perspectives on disclosure April Hernandez, MSc Regulatory Consultant, Life • Challenges in regulations and changing environments Sciences Clarivate Analytics • Best practices for improving efficiencies and harmonization Teresa Fishburne Global Practice Leader, Clinical and Regulatory Consulting • Role of technology Services Clarivate Analytics • Summary Robert A. Paarlberg Principal Paarlberg & Associates LLC Insert footer
Overview of the clinical trial disclosure and transparency landscape Paarlberg & Associates LLC 4
Key disclosure/transparency milestones ICMJE – NIH Final Rule (9/16) FDAMA 113 Registration (11/97) CT.gov Results ICMJE – Data FDA ‘CSR Pilot’ Requirement Reporting Sharing Plan (1/18) (7/05) (9/09) CT.gov database (1/19) Lay Summaries launched (2/00) ICMJE - Data Sharing Mandated Statement FDAAA 801 (est. 4Q22) (7/18) (9/07) 2009/11 2014 2015/16 2019 2020 2020+ 1997 2000 2001 2005 2007 2018 EMA Policy 0070 EMA Policy 0043 (1/15) (11/10) EU Clinical Trials Directive EudraCT Results Reporting 2001/20/EC (7/14) EU Clinical Trial (4/01) Information System EU Clinical Trial Regulation (est. 4Q20) (4/14) Health Canada Public U.S. Transparency Canada Transparency EU Clinical Trial Register Launched Release of Clinical Initiatives Initiatives (3/11) Information EU Transparency ICMJE Policies (3/19) Initiatives Paarlberg & Associates LLC 5
Clinical trial disclosure continuum During the lifecycle of a clinical trial these core documents must be disclosed Disclosed Disclosed on on ClinicalTrials.gov EudraCT Lay Summaries Clinical Clinical Statistical Clinical Study Study Study Study Information Analysis Protocol Results & Updates Report Plan Data Affiliates/CROs prepare CTAs EMA Health Publication Authorities Scientific Website Congresses Country Journal Registries Publications Paarlberg & Associates LLC 6
Clinical data flow Publications Journals Publications Planning Posters Scientific Clinical Symposium Development/ TLGs Presentations Regulatory Process Common Clinical Study Protocol * SAP* Technical Report Document Patient Level Narratives Data Clinical Trial Protocol Transparency Registration Redacted & Summary Lay Anonymized Clinical Results Summary Data Posting Protocol Amendments* Data Sharing Data Sharing Requests *The Protocol, SAP, and all Global Protocol Amendments must all be included as part of the Summary Results Posting for ClinicalTrials.gov. Paarlberg & Associates LLC 7
Clinical trial disclosure stakeholders Who is looking at ‘your’ data? ‘Transparency Competitive Watchdogs’ Financial Analysis Competitors Community (e.g., FDAAA/EU Trials Companies Tracker, AllTrials, Bioethics International) Academic Third Party Plaintiff Journal Editors Researchers Payers Attorneys Healthcare Patients Practitioners Paarlberg & Associates LLC 8
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
A solution to these challenges Case study • 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)
Challenges in regulations and changing environments The Lebanese Ministry of Public Health • 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
Challenges in regulations and changing environments Brazilian Ministry of Health • 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.
Challenges in regulations and changing environments WHO International Clinical Trials Registry Platform • 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
Best practices for improving efficiencies and harmonization Monitor the landscape Conduct in-depth Keep all departments Establish a for changes and analysis to inform informed and on top of transparency steering potential issues R&D activities regulatory changes 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
Role of technology • Enables regular intelligence updates to ensure Optimal solutions your teams are referencing most current should meet information and remain compliant these criteria • 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
Benefits of technology • Notify teams of new assignments and manage Increase accuracy, their workload through task management and speed and collaboration tools productivity • 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
Leverage technology to prioritize tasks and remain compliant Collaborate Reduce risk Optimize Streamline Drive efficiencies Quickly Increase Reduce time and by utilizing a single communicate transparency resources spent on point of customized changes, updates through organized searching for regular updates and alerts with monitoring and information and that fits seamlessly others across all prioritization to expertise – instead, into existing functional areas to draw attention to monitor workflows ensure consistency immediate actions performance
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