 |
|
|
| 1.4 Synthesis |
| |
| |
| 
|
The matrix of the
definition process of priorities in health research
addressed the following variables: research need, priority
lines, methodology, construction of the call for bid
and participant institutions. |
|
| |
Synthesis of the
definition process of priorities in health research
To systematize and
represent the diversity of the definition process of priorities
and innovation in neglected diseases a synthesis was elaborated,
contemplating the discussion on the six disorders, in agreement
with the following variables:
- Need for Research, Development
and Innovation in Health. The proposal of discussion
in the groups included a inventory of R&D&I needs
for all of the disorders. The obtained results subsidized
all of the discussion stages
- Priority lines. Definition of the lines
of research priorities after going through all of the
stages foreseen in the methodology
- Methodology. As the definition process
of priorities in health research meets the construction
phase, it is important to know the potential and limitations
of the proposed methodologies
- Construction of the call for bid. In
some cases the group moved forward in the recommendations
about the burden of projects and financing strips, or
support modality for the call for bid
- Participant institutions that
relate to the composition of each workgroup, identifying
the partnerships of Decit and of CDTS / Fiocruz.
To proceed, the synthesis of the definition
process of priorities and innovation in neglected diseases:
|
Malaria
|
| R&D&I
needs
Expert
- Increase of cases: 2003. 300.000
and 2005. Approximately 500.000 cases, 80% for the
Plasmodium vivax Greater concentration in studies
of Plasmodium falciparum.
- Studies on asymptomatic infected
individuals and development of kit to identify cases.
- The resistance to the chloroquine
(20 to 30% in patients in endemic areas), also points
out the need for developing of new drugs.
- Development of an anti-malarial
vaccine, like the international laboratories (mainly
the Americans).
- Clinical and pre-clinical studies.
- Molecular mechanisms of resistance
to drugs and virulence.
- Asymptomatic patients’ epidemiology.
- Identification of new control
targets (drugs and vaccines) using genomic, post-genomic
and bio-informatics.
- New targets for diagnosis.
- Epidemiology and alternative controls
of vectors.
Ministry
of Health's Technical Area
- Placed priority on studies to
Assess alternative methods for anophelines capture;
vectorial competence of Anopheles marajoara and
Determinant factors associated with malaria transmission
in the Southeast Region (Espírito Santo and
Rio de Janeiro).
Thematic Group –
Malaria
- Scientific and technological
research activities, development and innovation
in the diagnosis / treatment (early) fields and
control of vectors, besides the reinforcement of
required infrastructures to accomplish such research
works, structuring research networks, the groups
approach to the endemic and non-endemic areas.
- Since it is an initiative by
the Ministry of Health the criteria to be considered
for the approval and financing of projects, should
take into consideration, besides the scientific
merit and installed competence of the proposing
group, the demand for public health as diagnosed
by the participation of experts in the area, with
experience in scientific research.
Methodology
- The proposed methodology was
adopted comprehensively. It went through all of
the steps and answered the questions presented by
the schedule.
- The group discussed the themes:
clinic, vectors, epidemiology and control, otherwise
through the nature of the requested innovations:
new findings, new methods, new interventions, new
strategies.
- The decision was made for a political
approach to the diagnosis about the misuse of available
instruments to control malaria, and new instruments
to face the residual malaria.
Priority lines
- Clinical and pre-clinical studies.
- Identification of new objectives
for vaccines, diagnosis, immunotherapy, using information
ensued by genome technologies, post-genome, including
functional aspects and bio-informatics.
- Studies on molecular mechanisms
of parasites resistant to drugs, and of vectors
resistant to insecticides, along with the identification
of new targets and the development of new products,
notably based on biodiversity and knowledge of the
genomic and post-genomic, including functional aspects
and bio-informatics.
- Physiopathology studies, including
molecular studies of the parasite, and therapeutics
in serious forms of P. falciparum and P. vivax malaria.
- Epidemiological studies in an
out of endemic areas, in particular on prevalence
and role of asymptomatic bearers of parasite and
vectors (vectorial competence), and proposition
of alternative methods of control.
The Program should also address:
- The need for improving infrastructure
to carry out the clinical (referral of clinical
centers among hospitals accredited for clinical
research in phases 1 and 2) and pre-clinical (reinforcement
and improvement of physical conditions and of the
human resources in the existing Primatology Centers
in the Ministry of Health.
- The construction or adaptation
of insecticides/infector breeding sites for developing
research involving the handling of infected vectorial
insects, fostering the colonization of main vectorial
species and obtaining reference colonies.
- The creation of a relational
database system and its shared management for the
six neglected diseases.
Construction of the call for
bid
- Great-, medium- and small-size projects should
be addressed according to the quality and potential
impact of the proposal, avoiding however, the excessive
pulverization of resources.
- All of them should foster the establishment of
cooperation networks.
- Multi-centric studies whenever convenient and
effective.
- Support for emerging groups exceptionally, in
function of the Program profile, in search of solutions
for problems in public health (Decit in the Ministry
of Health.
- 30% of the call for bid resources should be invested
in the North, Northeast and Central-West regions
maintaining rigorous quality control and pointing
out, whenever applicable, the pertinence of networking.
Institutions
- USP – University of Sao
Paulo
- IOC/ FIOCRUZ – Oswaldo
Cruz Institute of FIOCRUZ
- IPEPATRO – Institute of
Research in Tropical Pathologies
- ICB/USP – Institute of
Biological Sciences of the University of Sao Paulo
- HUCFF/UFRJ – Clementino
Fraga Filho Academic Hospital of the Federal University
of Rio de Janeiro
- IPEC/FOCRUZ – Research
Institute Evandro Chagas
- SVS – Health Surveillance
Secretariatt - Ministry of Health
|
|
| |
Chagas’
Disease
|
| R&D&I
needs
Expert
In spite of the Chagas’
disease being classified by TDR as Category III, the
question of chemotherapy would place it in Category
I, due to the lack of effective medicines for treating
this disease, and so being a priority for clinical
trials to develop new medicines.
- Other priorities: resistance of
the parasite to the drugs used; study of risk factors,
including malnutrition, which is associated with
the infection; basic research in the transmission
dynamics as a way to fight the vector
Ministry of Health's
Technical Area
- Study PCR validation as a methodology
to confirm Chagas’ disease.
- Study on the evaluation of teratogenic
and reproductive effects of Chagas’ disease
and treatment with benzonidazol.
- Evaluation of therapeutic response
to the different strains of T. cruzi in several
geographic areas.
- Evaluation of the resistance
of T. cruzi to different temperatures.
- Study of the therapeutic response
of T. cruzi according to the transmission means
(oral, vectorial, blood transfusion, congenital).
Thematic Group –
Chaga’s disease
- The current estimates suggest
the existence of two to three million infected individuals.
In the areas of the South, Southeast, Central-West
and Northeast regions, the transmission of vectorial
intradomiciliary and transfusion-based were sharply
reduced. There are some focuses of T. infestans
remaining in the States of Bahia, Rio Grande do
Sul and Minas Gerais.
- The presence of Chagas’
disease in the Amazon Region became clearly evident,
whether based on diagnosis of micro-epidemics of
acute cases, or on the integration of Chagas’
Disease surveillance to the Malaria surveillance
program (diagnosis with thick blood film).
Methodology
- The proposed methodology was
adopted and partially used by the group.
- Work was concentrated on setting
five priority themes and inside each one of them,
the sub themes along with the pertinent recommendations.
- It was decided to place emphasis
on the Amazon region and review the priorities of
specific studies for that area.
- It used the study on the disease
burden and epidemic trends of the disorder.
Priority lines
Five priority themes were considered:
- Amazon region
- Study of vectors
- The search for new drugs and
improvement of chemotherapy
- Search of evolution markers and
prognostic for chronic Chagas’ disease and
the Trypanosoma cruzi resistance to drugs.
Construction of the call for
bid
The recommendation for the Amazon
Region theme was to develop NETWORK-based studies,
articulating emerging and consolidated groups in the
region.
- Projects of medium (individual
or network support) and big size (support to networks).
- It was recommended to rest on
a project coordinator with experience and scientific
production in the theme of the project.
- Research teams with, at least,
a doctor or senior consultant’s certified
participation.
Institutions
- UFGO – Federal University
of Goias
- USP – University of Sao
Paulo
- UFMG – Federal University
of Minas Gerais
- UFRJ – Federal University
of Rio de Janeiro
- IPEC/FIOCRUZ – Research
Institute Evandro Chagas
- FUNASA – National Heath
Foundation – Ministry of Health
- IOC/FIOCRUZ –Oswaldo Cruz
Institute
- SCTI/RJ – Department
of Science, Technology and Innovation of Rio de
Janeiro State
|
|
| |
Dengue
|
| R&D&I
needs
Expert
- The following points were highlighted
as important for public policies on dengue control:
the study on atypical forms of the disease manifestation;
development of a fast diagnosis method and the vaccine
elaboration to combat the endemic, which has also
been subject of surveys.
Ministry of Health's
Technical Area
- Methodology of evaluation of
the density of infestation working on other stages
than the non larval: pupa, adult, egg; to establish
the links among the methods and determine levels
of transmission risk.
- Operational model of a stratified
field, that considers different degrees of transmission
risks (infestation levels, notifications, socio-environmental
conditions, preferential deposits, among others)
in great urban centers.
- Improvement of the current system
of dengue information - New strategies of fast monitoring
for integrated analyses of clinical-epidemiological,
entomological and virological data.
- Predictive models of the risk
of infection transmission by the dengue virus.
- Development and application of
an evaluation methodology for the municipal programs
activities of dengue’s control in relevant
aspects for the integrated administration of their
components (control of vectors, epidemics surveillance,
attendance, communication and mobilization).
- Study on the population’s
risk perception.
- Fast serologic test for use in
field conditions, as a supporting tool to preventive
activities and dengue control.
Thematic Group –
Dengue
- Development of field operational
strategies, stratified, complementary or alternative,
which consider different degrees of transmission
risk (infestation levels, notifications, socio-environmental
conditions, preferential deposits, among others)
in large urban centers (original proposal of Ministry
of Health for the call for bid) – the group
suggested that this item should not be part of the
call for bid. The Work Group suggests that the Ministry
of Health should look for partners to accomplish
this project, jointly with research institutions
and State and/or Municipal Health Secretariats.
- Stimulus to laboratories willing
to collaborate with the monitoring of the populations’
resistance to Aedes aegypti to insecticides
used in the National Program of Dengue’s Control
(Programa Nacional de Controle da. Dengue –
PNCD) (MoReNAa) – draft recommendation to
Decit.
- Recommendation for larger integration
among different programs of vectors control.
- To include PNCD technicians in
the projects evaluation commission for this call
for bid.
- The Ministry of Health should
support the Brazilian research groups working in
the development of a vaccine against the dengue
virus.
- Support to projects of insectaries
and infectors infrastructure.
- Incentive to laboratories
willing to collaborate in monitoring the resistance
of populations of Aedes aegypti to the
insecticides used in PNCD (MoReNAa).
Methodology
- The group adopted the proposed
methodology; it went through the stages and answered
the questions presented by the script.
- They dedicated part of the time
to discuss and incorporate the recommendations from
the Ministry of Health’s technical areas as
well as experts about the inventory of R&D&I
needs for the area. In some cases, they had fully
contemplated the recommendations.
Priority lines
- Three priority lines were
defined:
- Vectors
- Epidemiology, surveillance
and control
- Clinical-Laboratorial
Note: Every priority line covered
sub-themes
Construction of the call for
bid
- Include PNCD technicians in the
commission to evaluate projects in this call for
bid.
- Support, preferably networked
but, depending on the proposal, individual projects
should be addressed. In what concerns projects of
clinical studies, only networked projects should
be contemplated.
- Support to multi-centric studies
depending on the nature of the project.
- Support to emerging groups should
be conditioned to projects in networks, to expand
their technical-scientific capacity-building.
- 30% of the resources of the call
for bid allotted to the North, Northeast and Central-West
regions should consider the proposal’s scientific
merit, priority of networked projects submitted,
mainly when the groups are not fully qualified.
Institutions
- Ministry of Health
- USP – University of Sao
Paulo
- IOC/FIOCRUZ – Oswaldo Cruz
Institute
- SMS – Municipal Health
Secretariat - Goiânia/GO
- UFBA – Federal University
of Bahia
- UFV – Federal University
of Viçosa
|
|
| |
Leishmaniasis
|
|
R&D&I needs
Expert
- Themes: entomology, diagnosis
and resistance of the parasites to drugs.
Entomology: The lack of knowledge on the most
important phlebotomus species in the transmission
chain, the non-homogeneous distribution of
the vector in geographical areas, and the
parasites / host relationship, implies the
need for more basic research. Diagnosis: There
is a need for identifying false positive cases,
and nanotechnology should be considered in
this area. resistance of the parasites to
drugs (pentavalent antimonials): Not only
the aggressiveness of these drugs should be
a concern for basic research, but also their
several side effects. The study on blocking
the transmission through vaccine development
was also mentioned.
- Vectorial transmission:
problems or flaws in the findings?
- Leishmaniasis: identification
of more virulent parasites.
- Leishmaniasis: clinical
and laboratorial diagnosis: problems and flaws.
- Leishmaniasis: interaction
with other illnesses.
- Leishmaniasis: early identification
of resistance to drugs
- Leishmaniasis: development
of new drugs.
- Leishmaniasis: development
of effective vaccines.
Ministry of Health's
Technical Area
- Clinical study to evaluate
the efficacy of Amphotericin B Deoxycholate
and Amphotericin B Liposome, compared with
the Meglumine Antimonite in patients with
Visceral Leishmaniasis.
- Study to evaluate the cost
effectiveness of the Meglumine Antimonite,
Amphotericin B Deoxycholate and Amphotericin
B Liposome in treated patients with Visceral
Leishmaniasis.
- Clinical study to evaluate
the effectiveness of Amphotericin B Deoxycholate,
compared with the Meglumine Antimonite in
patients with Tegumentary Leishmaniasis.
Methodology
- Initially, the experts
identified the needs for R&D&I in
the area.
- The proposed methodology
was used to identify relevant subjects to
the theme, and to highlight the type of flaw
in each problem presented.
- The group moved forwards
in the discussion and presented several recommendations
for the call for bid.
Priority lines
- Leishmaniasis: general
aspects
- Leishmaniasis: study of
the parasite
- Leishmaniasis: study of
the disease
- Leishmaniasis: diagnosis
- Leishmaniasis: treatment
- Leishmaniasis: vaccination
- Leishmaniasis: vectors
- Leishmaniasis: reservoirs
- Leishmaniasis: control
Transversal Themes
- Bio-informatics tools to
explore the genomes of infectious agents and/or
vectors of the target disease.
- Systems of high performance
evaluation to explore compounds or combinatorial
chemistry library of compounds.
- Incentive to the inventory
of transversal technologies in vaccination
(adjuvant agents, new approaches).
- Aspects of information
and education for society.
Construction of the
call for bid
- It highlighted the importance
of dealing with the disorder in an integrated
way considering parasite, host, vector and
external factors (environmental, drugs etc.).
It should foster the submission of proposals
on integrated projects involving different
aspects of priority themes in leishmaniasis.
- The proposals should be
articulate and present clearly defined objective,
to which the several projects contribute.
- To promote the integration
of emerging groups, with emphasis in the North,
Northeast and Central-West regions, the letters
of intention, in a first stage, could be submitted
by isolated groups (small size proposals)
or by associate groups with medium- or big-size
proposals. However, at the end of the selection
process, the isolated successful proposals
should be integrated into programs of medium
or big size.
- In order to foster interdisciplinary
and/or multi-centric studies, but avoiding
the artificial induction of co-operations,
we suggest a two-stage submission of projects:
Letter of Intention and Final Proposal.
Institutions
- Gonçalo Muniz Research
Center of the Oswaldo Cruz foundation
- USP – University
of Sao Paulo
- IPEC/FIOCRUZ – Research
Institute Evandro Chagas
- UFPI –Federal University
of Piauí
- IOC/FIOCRUZ –Oswaldo
Cruz Institute
- UFRJ – Federal University
of Rio de Janeiro
- UFBA – Federal university
of Bahia
- CNPq – National Council
of Scientific and Technological Development
- CONASEMS –
National Council of Municipal Health Secretaries
|
|
| |
Tuberculosis
|
|
R&D&I needs
Expert
Immediate need for the
study of new drugs that makes it possible to
reduce the time in treatment and to further
the investigation on the association between
TB and HIV/Aids.
Methodology
The group went through
all of the stages foreseen in the methodology
and it adapted the strategic matrix to meet
the area representation needs. At the end, it
set and hierarchized the priority lines of research.
- They used a matrix and
crossed the need for new knowledge, new tools
and evaluation of interventions, strategies
and policies with the expected results in
the short, medium and long run.
Priority lines
- Study of the health service
(structures, process and result), social,
anthropological, and economical indicators
for assessing tuberculosis control.
- Study of parameters in
tuberculosis dynamics and its application
in the epidemiologic surveillance.
- Spatial distribution and
characterization of risk areas for tuberculosis.
- Study of contact ways with
pulmonary tuberculosis, transmission mechanisms
and control measures.
- Effectiveness of new medicines,
new schemes, new therapeutic and prophylactic
regimens for tuberculosis.
- Validity, reliability and
cost effectiveness of new diagnosis methods
for tuberculosis.
- Pharmacokinetics and pharmacosurveillance
of tuberculosis.
- Epidemic impact of HAART
in morbidity and mortality for tuberculosis
in people living with HIV/AIDS.
- Effectiveness of biosafety
measures for tuberculosis in health units
at different levels.
- Pharmacogenetics, immunopathogenesis,
and markers of infection, disease, cure and
recidivation of tuberculosis.
- M.tuberculosis: genotyping,
virulence and ecological factors associated.
- Social and occupational
repercussions of tuberculosis consequences.
- Research and development
of new diagnosis methods, new vaccines and
new medications for tuberculosis.
- Effectiveness of
new vaccines for tuberculosis.
Construction of the
call for bid
Place priority
on projects
- Of a small and large size.
- Inter-institutional.
- Of emerging groups.
- And, for the 30% investment
of the resources of the Call for Bid, for
the North, Northeast and Central-West regions,
use the list in order of research priorities.
Institutions
- UFRJ – Federal University
of Rio de Janeiro
- USP/RP – University
of Sao Paulo, Ribeirão Preto
- PUC/RS – Catholic
University of Rio Grande do Sul
- SBPT – Brazilian
Society of Pneumology and Tisiology
- UERJ – State University
of Rio de Janeiro
- SVS – Health
Surveillance Department - Ministry of Health
|
|
| |
Hansen’s
Disease
|
R&D&I
needs
Expert
- Studies that make possible
the cure of the disease; basic clinical research
that make the recognition of Hansen’s
disease possibly starting with the evaluation
of wounds; better contribution to meet SUS
demands regarding assistance.
- The publicization of the
existent theoretical and practical knowledge
was recommended for the population, with the
aim to help in seeking recognition and treatment
of the disease.
Ministry of Health's
Technical Area
- Sampling Study of Multi
Drug Therapy - MDTA.
- National school inquiry
of prevalence of Hansen’s disease.
- Study of cost and effectiveness
of early treatment in reactional multibacillary
Hansen’s disease.
- Study of the magnitude
of Hansen’s disease in quilombolas and
indigenous communities.
- Research to validate new
cases of Hansen’s disease.
- Study of Thalidomide syndrome
markers.
Thematic group
– Hansen’s disease
Development of:
- New diagnosis tests for
Hansen’s disease.
- New marker and predictor
tests of Hansen’s disease reaction.
- New recurrence markers
and medical resistance.
- New markers of genetic
susceptibility.
- New control strategies
of Hansen’s disease.
Studies of:
- Chain of transmission of
the Hansen’s disease.
- Identification of risk
groups.
- New drugs for the treatment
of Hansen’s disease and Hansen’s
reactions.
- Magnitude of the adverse
effects of medicines used to treat Hansen’s
disease.
- Co-morbidities and mortality
in Hansen’s disease
- Tests based on molecular
biology for diagnosis, resistance and transmission.
The highlighted
necessary activities of R&D&I
Studies to determine the
recurrence race and drugs resistance in Hansen’s
disease; validation of operational diagnosis
criteria; validation of epidemiological and
operational indicators on Hansen's disease control;
sustainability of the decentralization process
in Hansen’s disease.
Demands of the
Hansen’s disease patients after release
Prevention and rehabilitation
strategies in the different complexity levels;
Strategies on information, education and communication
for Hansen’s disease.
Implementation
of:
- Tests already available
for Hansen’s disease.
- Control Strategies for
Hansen’s disease in the primary health
care.
Methodology
Effort for development
of operational Research
- The group used the proposed
methodology, went through all of the stages
and answered the questions posed.
- It used the study of the
disease burden and the epidemiological trends
of the disorder, and concluded that there
is little knowledge concerning the epidemic
behavior of Hansen’s disease. The existing
data indicate an uneven situation concerning
data coverage and quality.
Priority lines
- New tests for diagnosis,
resistance, susceptibility and transmission.
- Prediction markers of Hansen’s
disease reaction.
- Markers of risk groups.
- New schemes and regimens
for the treatment of Hansen’s disease
and its reactions.
- Evaluation of strategies
for control of Hansen’s disease in primary
health care attention.
Construction of the
call for bid
- Recommendations on financing
strategies submitted to Decit.
- Projects of small and medium
size.
- Support to inter-institutional
projects, prioritizing the interaction research-control,
including emerging groups.
Institutions
- IOC/FIOCRUZ – Oswaldo
Cruz Institute
- UFC – Federal University
of Ceará
- UFBA – Federal University
of Bahia
- UNB – Federal University
of Brasilia
- UFU/Uberlândia –
Federal University of Uberlandia
- UFRJ – Federal University
of Rio de Janeiro
- ENSP/FIOCRUZ – National
School of Public Health
- USP/RP – University
of Sao Paulo - Ribeirão Preto
|
|
| |
|
|
| |
|