Transcript Slide 1

INAT and Research
First Meeting of the Core
Group of the
Subgroup on Introducing
New Tools and Approaches
(INAT)
12th November 2010
Berlin
Christian Lienhardt
Stop TB Partnership
Geneva
Aims of this presentation
Background: the TB situation today
The Stop TB strategy and the Global Plan to
Stop TB 2006-2015
Why a revised Global Plan to Stop TB 20112015 ?
The role of new tools in achieving the goal
of TB elimination
Key challenges and opportunities that can
facilitate or impede the Plan’s success: the
role of INAT
The global burden of TB in 2008
Estimated
number of
cases
All forms of TB
Estimated
number of
deaths
1.9 million
9.4 million
(range 8.9–9.9 million) (range 1.6–2.3 million)
HIV-associated TB
1.4 million (15%)
(1.3–1.6 million)
520,000
(0.45–0.62 million)
Multidrug-resistant
TB (MDR-TB)
440,000
(0.39-0.51 million)
150,000
(0.05–0.27 million)
The global response:
Stop TB Strategy & Global Plan
1.
Pursue high-quality DOTS
expansion and enhancement
2.
Address TB-HIV, MDR-TB,
and needs of the poor and
vulnerable
3.
Contribute to health system
strengthening
4.
Engage all care providers
5.
Empower people with TB
and communities
6.
Enable and promote
research
TB Control Global Targets
2015: Goal 6: Combat HIV/AIDS, malaria and other diseases
Target 8:
Indicator 23:
Indicator 24:
to have halted by 2015 and begun to reverse the
incidence…
incidence, prevalence and deaths associated with TB
proportion of TB cases detected and cured under DOTS
2015: 50% reduction in TB prevalence and deaths relative to 1990 levels
2050: elimination (<1 case per million population)
Full implementation of Global Plan: 2015 MDG
target reached but TB not eliminated by 2050
Incidence/million/yr
10000
1000
Projected
incidence 10x
lower than today,
but 100x bigger
than elimination
target in 2050
100
10
Elimination
target: 1 /
million / year
by 2050
Elimination 16%/yr
Global Plan 6%/yr
Current trajectory 1%/yr
1
2000
2010
2020
2030
Year
2040
2050
Source: L. Abu Raddad et al, PNAS 2009
Potential impact of new TB vaccines,
diagnostics and drugs in SE Asia
"Moving beyond the TB box"
Core TB
control area not enough
TB care and
control
Health systems
And policies
Development
Research
Need to
expand on
research
Strengthening the fight
The Global Plan 2006-2015
defined direction and costs
The Global Plan 2011-2015
strengthens the fight
11 billion US$
to develop
new tools
9.8 billion US$
to develop new
tools
Improve TB Control
Basic
Science
Translational
Studies
Preclinical
Studies
Clinical
Studies/Trials
Operational
Studies/Trials
Improve TB Control
Develop
Point of Care
Diagnostics
Basic
Science
Develop a
Safe and
Effective
Vaccine
Transform the
Field of
Therapeutics
Translational
Studies
Preclinical
Studies
Clinical
Studies/Trials
Operational
Studies/Trials
• Knowledge gaps
Fundamental questions in TB
• Resources gaps
Fundamental Research
• Fundamental science is an integral part of an
aggressive,
transformational research response to the continuing global
TB epidemic
• FR is crucial to addressing questions that underpin
development of new diagnostics, drugs and vaccines and the
creation of improved control strategies to meet the goal of
elimination of TB by 2050
Diagnostics Development
• To diagnose all forms of TB (PTB, EPTB, DS/DR-
TB, LTBI) in all populations
• To develop a Point of Care Diagnostics of TB
• To develop a Point of Care Diagnostics of Latent
TB Infection
• To ensure wide availability of and equitable access
to new diagnostic tools at all health care levels in
endemic countries
Targets for introduction of new
diagnostic tests 2006–2015
Integration of new diagnostics in
the tiered health system
•Surveillance
•Reference methods
•Network supervision
In house DST
(MODS, NRA,
CRI) Special
LC / DST
15d/ 30d
Reference
Labs
settings and
conditions
•Resolution testing
(screening-test negative
drug resistance)
SC / DST
LC / DST
30d / 15d
60d / 30d
Regional
Labs
LPA Rif / INH 2d
District
Level
•Screening
•Passive case finding
•Detect and treat
SubDistrict
Level
Microscopy
Level
•Clinical
Screening
•Primary care
Community
Level
Strategic
focus 2 & 3
Integrated NAAT +40% /2h
ZN 2-3d
LED FM +10%
Manual NAAT+25%
RDT Gen1 / Gen 2
Strategic
focus 1
Drug Development
• To develop safe, short and high-efficacy drug regimens for
treatment of DS-TB, DR-TB and LTBI, that can be used in
children and in combination with HIV treatment;
• To build and maintain trial site capacity necessary to
support trials for drug-sensitive and -resistant TB, as well as
latent TB infection;
• To ensure clear and efficient regulatory guidelines for
approval of new TB drugs and regimens, from development
to registration, and ensure adoption of new TB drugs and
regimens at the country level.
Drug Development Pipeline
Vaccine Development
• To develop safe, short and high-efficacy drug regimens for
treatment of DS-TB, DR-TB and LTBI, that can be used in
children and in combination with HIV treatment;
• To build and maintain trial site capacity necessary to
support trials for drug-sensitive and -resistant TB, as well as
latent TB infection;
• To ensure clear and efficient regulatory guidelines for
approval of new TB drugs and regimens, from development
to registration, and ensure adoption of new TB drugs and
regimens at the country level.
Vaccine Development Pipeline
Operational Research
•
•
The "missing link" between development of new tools
and effective uptake in programmatic practice
include several aspects:
• improving programme performance and outcomes;
• assessing the feasibility, effectiveness and impact of
on-going or new strategies or interventions on TB
control;
• collecting data to guide policy recommendations on
specific interventions.
Funding required - Global Plan to Stop TB 2011-2015
What are the research challenges for full
implementation of the Global Plan ?
1. Massive scale-up of research necessary to accelerate progress in TB
control
2. Profound need of Fundamental research "upstream" to feed the
development of new tools for TB control
3. Better understanding of the whole spectrum of infection for
development of appropriate diagnostic and prevention tools
4. Need to field test new drugs, diagnostics and vaccines in GCLP
compliant sites→ capacity building and technology transfer
What are the research challenges for full
implementation of the Global Plan ?
5. Need of combined and synergistic implementation of several novel
strategies:
- diagnosing TB much earlier
- treating cases in a much shorter time (≤ 2 months),
- scaling-up treatment of LTBI (especially in high-risk populations)
- mass vaccinations using a more effective vaccine
6. Research needed downstream to fight obstacles to optimal TB
control:
- early diagnosis and case detection (DS and DR-TB),
- prevent development of TB in high-risk groups,
- ensure uptake of innovations within existing health systems
7.
Weak health systems and services compromising TB care; lack of
bold policies on free access to care, drug quality and restriction, labs,
human resources, infection control, etc.
INAT Objectives
• To address the challenges of introducing and
implementing new tools or new approaches in TB control
programmes as an integral part of accelerating progress
toward the MDGs
• To set priorities for operational and evaluation research
that will facilitate the wide-scale implementation of new
tools or new approaches
• To advocate for the appropriate uptake of new tools and
approaches at the country level
• To track progress in the uptake and expansion of new
policies and approaches.
Removing Barriers: A role for INAT
In close collaboration with the Stop TB Partnership WGs, the TB Research
Movement and WHO/STB, the role of INAT would be:
•
to engage in early dialogue with partners (i.e. pharmaceutical
companies, regulatory authorities, research groups, technical
partners, PDPs and donors) to alert them on the need to take into
account programmatic questions;
•
to promote collaboration and action by partners for optimal use of new
tools to improve TB control in all populations, including HIV infected
persons and M/XDR-TB;
•
To assist in collecting evidence on the impact of new tools/approaches
on case detection, case management and equitable access to care to
inform policy development;
Removing Barriers: A role for INAT
•
to help guide/promote the conduct of feasibility studies and costeffectiveness studies at an early stage in collaboration with
partners, in order to inform policy-making;
•
to increase awareness and engagement of national authorities in the
implementation of policies and guidelines for proper use of new tools
and approaches at all levels of health care
•
to contribute to the harmonization of regulatory requirements for TB
diagnostics, drugs and vaccines
Thank you for
your attention !