Download Roche Sponsored Clinical Trials in `Developing Countries`

HIV, Globilisation and Futures:
HIV Clinical trials in a global world
Dr Gillian Hales
Roche Products
HIV and the Futures of Globilisation
HIV and Globilisation are issues that relate to the individual
and to the global community
Globilisation has led to increased information and
expectations
The effect of Globilisation on Clinical trials & changes for the
Pharmaceutical Industry
‘Developing Countries’ – An Umbrella
Term
Tiers defined by economic status (World Bank)
Least Developed Countries (LDCs)
e.g. Cambodia, Afghanistan, Haiti, Uganda
Defined by profound poverty & weakness of economic,
institutional and human resources
Low Income Countries
e.g. India, Indonesia, Vietnam
Lower Middle income Countries
China, Philippines, Thailand
HIV and the Futures of Globilisation
Why should we undertake clinical trials in developing countries?
Broader demographics
Different clades
Large number of treatment naïve patients
HIV and the Futures of Globilisation
Ethical issues in clinical trials in developing countries
Ensuring that drugs post study are affordable
Ability for poor patients to provide informed consent
if no other treatment options accessible
Different standards for trials in developing countries vs. high
income countries e.g.:
Usage where contraindicated, e.g. breastfeeding
“Sub- standard” therapy
HIV and the Futures of Globilisation
What do clinical trials provide in developing countries?
Infrastructure
Education
Treatment
HIV-NAT
HIV Netherlands Australia
Collaboration (HIV-NAT),
Thailand
Research
HIV-NAT has completed 10 trials and is currently
involved in conducting 12 additional trials in which
approximately 1500 people are currently enrolled
Post-trial patients are receiving antiretroviral therapy
at 17 sites throughout Thailand
The HIV Netherlands Australia Thailand research collaboration: lessons from 7 years of clinical research
Kelly Safreed-Harmona, David A. Cooper, Joep M. A. Langec, Chris Duncomb, Praphan Phanuphakd
AIDS 2004, 18:1971–1978
HIV-NAT
HIV Netherlands Australia
Collaboration (HIV-NAT),
Thailand
Research
HIV-NAT opened in 1996 with only one physician,
two nurses and two part-time laboratory staff
members.
The organization now employs 40 people, including
6 physicians and 10 nurses.
The HIV Netherlands Australia Thailand research collaboration: lessons from 7 years of clinical research
Kelly Safreed-Harmona, David A. Cooper, Joep M. A. Lange, Chris Duncomb, Praphan Phanuphakd
AIDS 2004, 18:1971–1978
Eight Roche Policies Relevant to
‘Developing Countries’
Clinical trials (x2)
1.
2.
All Roche drugs
HIV/AIDS specific
Patents (x2)
Pricing (x3)
Drug donations
Policy posted on http://www.roche.com
Aim of Policies
Provide clear and consistent parameters with
guidance for action
A key part of Roche’s commitment to
sustainability in action
Roche HIV drugs
Roche HIV Clinical Trials
In
‘Developing Countries’
Covers Roche Sponsored Clinical Studies
AND
Roche Supported Third Party Clinical Studies
Roche takes responsibility for issues relating to third party studies
which it supports
Roche sponsored HIV studies
Continuous assured supply of Roche ARV for all participants after
trial ends assured for as long as they continue to receive medical
benefit from that medication, (provided that the benefit-risk ratio for
the product continues to support such use)
Provisions for post trial care to be secured before the trial
commences and clearly specified in patient consent forms
Description of post trial drug supply incorporated into the protocol
Support for third party sponsored HIV
clinical trials in developing countries
SoC according to accepted standards of therapy as defined in
WHO treatment guidelines for resource-limited settings or
international treatment guidelines
A written agreement describing how post trial treatment will be
assured for as long as participants continue to benefit from that
treatment
Preference given to studies in developing countries which include
centres in high income countries as well
Ethical standards demonstrably equivalent to those of a high
income country
Commitment to publish information on a public Clinical Trials
Registry
Roche Patent & Pricing Policies
Roche is committed to finding healthcare solutions that are
sustainable and have a long-term impact, particularly on the lives
of those living in the Least Developed Countries and subSaharan Africa
Roche aims to have a transparent patent and pricing policies for
all its medicines in the world’s Least Developed Countries
Roche Patent Policy
Not to file patents for any medicines – across all disease areas –
in the Least Developed Countries
Not to file patents on new or investigational HIV medicines in
Least Developed Countries and sub-Saharan Africa
Not to take action in Least Developed Countries and sub-Saharan
Africa against the sale or manufacture of generic versions of HIV
medicines
No patents for its treatments for malaria – Fansidar®
(sulfadoxine/pyrimethamine) or Lariam® (mefloquine) – in Least
Developed Countries and sub-Saharan Africa
Roche Pricing Policies
HIV protease inhibitors (Invirase and Viracept) supplied at
no profit to Least Developed Countries and sub-Saharan
Africa (69% of all people living with HIV worldwide)
Roche no profit prices are 30-59% lower than the price of
generic versions of these medicines
Reduced pricing for Invirase and Viracept available to low
and lower middle income countries (+ 24% PLWHA)
Roche Drug Donations Policy
Drug donations not a key component of our policies to increase
sustainable access to Roche medicines
Donating drug for chronic diseases is totally different to donating
emergency aid
Pegasys for cryptosporidium in children (Africa)
Valcyte (Uganda)
Rocephin (Cambodia)
HIV therapy is lifelong; unethical for Roche donate ARVs without
guarantee of lifelong continuous supply for each recipient
Regional commitment to HIV/AIDS
HIVNAT – Roche contribute to funding for HIVNAT
Cambodia Treatment Access Programme (CTAP)
Cambodia currently has the highest recorded HIV prevalence in
Asia, with over 170,000 people currently living with HIV/AIDS
CTAP was established in September 2003 and is a three-way
partnership between:
The Cambodian Ministry of Health
The National Centre in HIV Epidemiology and Clinical
Research (UNSW)
Roche
The new treatment centre has been established to provide a range
of clinical services and has been designed to provide the framework
for a comprehensive programme of training and research in HIV
medicine
Global commitment to HIV/AIDS
CARE Programme
The Cohort programme to evaluate Access to antiretroviral
(ARV) therapy and Education (CARE), which was set up by
Roche and Pharm-Access International
The program aims to widen access to HIV therapy by focussing
on disease education and building up local medical
infrastructure
Roche provides the funding plus HIV treatment and
diagnostic tests for the programme
Roche and HIV
Roche has a continued commitment to research and
development in HIV/AIDS
Development of novel pharmaceuticals and diagnostic
strategies to address key unmet medical needs,
including an investment of US $800 million dollars to
develop fusion inhibitors
Implementation of antiretroviral access programs in
resource-poor settings
Establishment of collaborative partnerships to help build
and strengthen healthcare infrastructures in these areas
Back-Up Slides
Roche Sponsored Clinical Trials in
‘Developing Countries’ - All drugs
Where continued treatment is necessary
e.g. life-threatening diseases – cancer
and no alternative treatment is available commercially,
an adequate supply of treatment is to be assured for all trial
participants following the trial, until Roche drug available commercially
Provisions for post trial care
to be secured before trial commences
to be specified in patient consent forms
Roche Supported 3rd Party Clinical Trials
in ‘Developing Countries’ - All drugs
The SoC according to accepted standards of therapy for the
treatment of the disease as defined in WHO or international
treatment guidelines
Preference given to studies in developing countries which include
centres in high income countries as well
Ethical standards demonstrably equivalent to those of a high
income country
Commitment to publish trial information on a public Clinical Trials
Registry and results and outcomes on a public repository