Transcript INDEPTH Effectiveness and Safety studies of antimalarials in Africa

INDEPTH Effectiveness and Safety
studies of antimalarials in Africa
(INESS )
IMPLEMENTATION SO FAR
Aziza Mwisongo
INDEPTH AGM
PUNE , INDIA
October 2009
Background and rationale
• Rationale approach for malaria treatment
policy
• Phase IV studies in real life conditions (drug
development pipeline)
• Accelerate the uptake of new antimalarial
drugs
Goal
• Overall Goal
– To provide national, regional and international
health decision makers with independent and
objective evidence on the safety and effectiveness
of new anti-malarial drugs as a basis for malaria
treatment policy.
Specific objectives
1. To develop and maintain Phase IV
effectiveness studies Platform in Africa
2. To assess the effectiveness of new malaria
treatment and its determinants in real life
health systems
Design and Implementation
• Phase IV studies will be multi-center studies in (Ghana,
Tanzania, Burkina Faso and Mozambique)
• Large well documented population at risk of malaria
residing in DSS sites
• Previous experience in interventions(Vit A, ITN, malaria
treatment guidelines)
• District wide implementation of new registered
antimalarials(Dihydroartemesinin-piperaquine,
Pyronaridine artesunate)
INESS Milestones- Objectives
Two major objectives ;
- To develop and maintain a Phase IV Effectiveness and
Safety Studies of antimalarials in Africa
- To asses the effectiveness of new malaria treatments
and its determinants in real life
Objectives and Activities
• Objective 1:
• Activity1a: Activation of the consortium governance, structures, task
teams and clearances across the platform
• Activity 1b:Developing training approaches and field protocols
• Activity 1c:Population and Health System Observatory functions
• Objective 2:
• Activity 2a:Determine effectiveness and Safety determinants of
antimalarials in real life health systems
• Activity 2b: HDSS and Health System Data Linkage
Activity 1: Activation of the consortium governance,
structures, task teams and clearances across the platform
- Governance structures are in place and fully
functional
- Task teams established and spearheading
research on health system effectiveness and
safety
- INESS research approved and granted both
national and Institutional IRBs in Ghana and
Tanzania
- Fully functional INESS secretariat based in
Tanzania
Activity 1b: Developing training
approaches and field protocols
- Key stakeholder consultation and by in of INESS work
obtained both in Ghana and Tanzania
- SOPs and specific research tools have been developed ,
piloted and rectified
- TOTs on research methods and tools of health system
effectiveness and safety have been completed for Tanzanian
and Ghanaian DSS sites
- Data collection on access, cost , adherence is ongoing both
in Ghana and Tanzania( Tapping on DSS rounds)
Activity 1c: Population and Health System
Observatory functions
- First planning meeting on data analysis and
management recently concluded
- First joint analysis meeting scheduled in Feb
2010( Core DSS data and INESS data )
- Post TOT mentoring planned scheduled in Feb
2010
- Roll in of Mozambique and Burkina Faso planned
early next year
Activity 2a: Determine effectiveness and
safety determinants in real life health systems
- Standard procedures for phase IV evaluation of anti
malarials already developed and further updates
during implementation
- Development of frameworks to aid drug choices and
policy changes for antimalarials will be developed
in 2010
- Generation and sharing of evidence will be on
continuous bases
Activity 2b: DSS and Health System Data
Linkage
- Innovative data collection equipments(PDAs and Tablet pcs)
have been purchased, tested and are being configured
- Plan for data collection using PDAs and Tablet Pc next rounds
for (access, cost, adherence and health provider compliance
questionnaires)
- Three softwares of data linkage have been developed (
identification of DSS members, capturing of health facility
data and linkages between HF and DSS data )
- Testing of operation of softwares planned in November
- Application of data linkage mechanism is expected early next
year
Other related progress
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INESS launched internationally
Website formed and already uploaded
Brochure designed and is being printed for wide distribution ,
International and national collaborations formed ( Drug
authorities, Roll Back Malaria, AFMs( Global Fund)
• National Communication Working Group identified in Ghana
• Negotiation to support Malaria Media groups in place
Challenges and lessons
• Long set up time ( at least 6 months )-ample
time
• Variation of expertise and availability of core
staffing in sites and secretariat- capacity
building
• Deployment of new drugs- earlier
negotiations with drug companies ( MMV)
and NMCPs