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

http://www.acresglobal.net

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

http://www.acresglobal.net