View
215
Download
0
Category
Tags:
Preview:
Citation preview
A Global Network for Clinical Research—Really?Greg Koski, PhD, MD, CPI (Honorary)
Associate Professor of AnesthesiaHarvard Medical SchoolSenior Scientist James Mongan Institute for Health PolicyCo-Founder,Alliance for Clinical Research Excellence and Safety
Drug development has been entirely proprietary and conducted largely in corporate silos
Clinical trials are not “global”—they are international
Harmonization is a euphemism for failure to standardize!
One cannot keep doing things the same way and expect different results
2
3
“The current approach to drug development is inefficient, ineffective and unsustainable.”
DIA Europe 2010
4
Global R&D Expenditure, Development Times, Global Pharmaceutical Sales & New Molecular Entity Output 1999-2009
*The development time data point for 2009 includes data from 2008 and 2009 onlySource: CMR International & IMS Health
5
Development Time For New Molecular Entities First Launched Onto The World Market 2000-2009
The development time data point for 2009 includes data from 2008 and 2007 onlyMajor companies are defined as those spending ≥US$ 2 billion in 2009 on ethical pharmaceutical R&D.
For many, the current approach to drug development has lost its way At one time, the foundation of pharmaceutical
industry was its desire to develop new medicines and devices to treat and prevent disease
That foundation has been undermined by financial motives
The industry has lost public trust and respect as a result
The industry is repeatedly charged with unethical conduct and exploitation
6
The failing silo business model must be reconsidered in light of dwindling pipelines, spiraling costs, growing regulatory burdens and declining productivity.
The erosion of public trust in the pharmaceutical industry must be addressed and the practices that have taken us down the current path must be changed.
7
THE GLOBAL AIR TRANSPORTATION SYSTEM
Global Network of Airports and
Air-Traffic Controllers
Standardized Policies and Operating Procedures
Shared Information
and Communicatio
ns Infrastructure
A GLOBAL AIR TRANSPORT “SYSTEM”
Airports
Travel Agencies & other Travel and Tourism intermediaries
Freight Forwarders
Industry SuppliersAirlines
IATA - INTERNATIONAL AIR TRANSPORT ASSOCIATION
The IATA was founded in Havana, Cuba, in April 1945.
It is the prime vehicle for inter-airline cooperation in promoting safe, reliable, secure and economical air services -- for the benefit of the world's consumers.
The international scheduled air transport industry is now more than 100 times larger than it was in 1945.
Few industries can match the dynamism of that growth, which would have been much less spectacular without the standards, practices and procedures developed within IATA.
www.iata.org
INTERNATIONAL AIR TRANSPORT ASSOCIATION
• to promote safe, reliable and secure air services.Safety & Security
• to achieve recognition of the importance of air transport worldwide social and economic development.
Industry Recognition
• to assist the industry to achieve adequate levels of profitability, by optimising revenues while minimising costs (fuel, charges and taxation).
Financial Viability
• to provide high-quality, value for money, industry required products and services that assist the airlines in meeting the needs of the consumer.
Products & Services
• to develop const-effective, environmentally-friendly, standards to facilitate the operations of international air transport.
Standards & Procedures
• to identify and articulate common industry positions and support the resolutions of key industry issues (congestion, infrastructure).
Industry Support
THE GLOBAL AIR TRANSPORTATION SYSTEM
Global Network of Airports and
Air-Traffic Controllers
Standardized Policies
and Operating Procedures
Shared Information
and Communicatio
ns Infrastructure
A GLOBAL CLINICAL RESEARCH SYSTEM
Global Network of Accredited
Research Sites and Research Ethics
Committees
Standardized Policies
and Operational Procedures
Shared Information
Infrastructure and
Pharmacovigilance System
A GLOBAL SYSTEM FOR DRUG DEVELOPMENT?
A global network of accredited, sustainable clinical research sites Trained and certified professional research
teams Standardized operating policies and
procedures Committed to highest standards of
performance Trusted in their communities and by their
global partners
14
A GLOBAL SYSTEM FOR DRUG DEVELOPMENT?
A shared infrastructure for clinical research that aligns good business practices with ethical principles to enhance safety and efficiency while reducing the cost and time required to bring new medical products to market.
Supported by a robust information technology platform to ensure safety and continually monitor and improve performance
The network would provide a framework for quality assurance and regulatory reform that would benefit the entire industry
15
BENEFITS OF A SYSTEMS APPROACH
Drives and rewards standardization Drives regulatory simplification and compliance Enhances performance
Increases efficiency Reduces redundancy
Promotes and enhances safety Reduces costs Increases transparency and improves public trust Promotes investment in sustainable, self-
supporting professional clinical research capacity in emerging nations and markets
16
IF WE BUILD IT, THEY WILL COME…
The Alliance for Clinical Research Excellence & Safety (ACRES), modeled after the International Air Transport Association(IATA), would: positively align ethics, scientific integrity and good
business practices provide appropriate opportunities and incentives
to further the mission of drug and device development
in a safer, scientifically sound, socially responsible manner that rewards all participants and stakeholders
IF WE BUILD IT, THEY WILL COME…
An independent, non-profit, non-governmental organization
Established/incorporated in an appropriate ‘international’ venue
Funded through an independent global trust fund supported by grants, donations, and user fees
Promote the use of existing tools, policies and processes rather than re-inventing them—
Facilitate abs streamline clinical research while improving safety and quality
ACRES NETWORK ARCHITECTURE—THE CORE
Site Development & Operations Support
Quality Management & Systems Improvement
InformationSystems Management
ACRESSecretariat
ACRES NETWORK ARCHITECTURE—THE SITES
Site Director
Principle InvestigatorsStudy
Coordinators
Data Manager
Operations Manager
Administrative Support Specialists
Principal Investigators
ACRES NETWORK INFRASTRUCTURE—THE NEURAL NET
Web-enabled, “cloud-based” integrated information system with central data warehouse and knowledge engines
System support/facilitation of all operations Point-of-entry EDC, including AE reporting SOP driven continuous compliance/quality control Shared data-base for trial initiation and support Centralized quality assurance and safety
monitoring
Recommended