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Managing global regulatory complexity

Clinical 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, MSc Regulatory Consultant, Life Sciences Clarivate Analytics Teresa Fishburne Global Practice Leader, Clinical and Regulatory Consulting Services Clarivate Analytics Robert A. Paarlberg Principal Paarlberg & Associates LLC

Overview of the clinical trial disclosure and transparency landscape

Paarlberg & Associates LLC 4

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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 Public Release 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 continuum

During 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

• n

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* Publications Planning 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 Companies Competitors Academic Researchers Plaintiff Attorneys Third Party Payers Journal 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 Health

Challenges 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
• f 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
• f 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 Health

Challenges 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 Platform

Challenges in regulations and changing environments

Best practices for improving efficiencies and harmonization

Monitor the landscape for changes and potential 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

• f 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

• thers 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

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