Inventory of R&D&I needs
The invited specialist highlighted
the following as needs: 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 of SUS to meet 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.
The Ministry of Health’s technical
area highlighted the following as relevant for the development
of the area:
- Sample study of Multidrug Therapy - MDT.
- National School Investigation on Prevalence
of Hansen’s disease.
- Cost-Effectiveness Study on Early Treatment
of Reactional Multibacillary Hansen’s disease.
- Study on the Magnitude of Hansen’s
disease in Quilombo and Indigenous communities.
- Research for validation of new cases
of Hansen’s disease.
- Study of syndrome markers of
Thalidomide.
Methodology
The group used the proposed methodology,
went through all of the stages and answered the questions
posed.
Setting Priority Research in
Health - Results
1. What is the nature
and size of the disease burden and what are the epidemiological
trends?
Little is known about the epidemiological
pattern of Hansen’s disease. The existent data indicate
an unequal situation in data covering and quality.
2. What are the current
available interventions and control strategies of the disease?
- Diagnosis: no gold-standard.
- Therapeutics: limited therapeutic regimens.
- Prevention/Rehabilitation: limited
effectiveness.
- Surveillance ways of contact: There
is no consensus on prevention with BCG and low covering
in the surveillance ways of contact .
- Information/Education/Communication:
inadequacy and complexity (Hansen’s disease x Leprosy).
- Control strategies: Controversies in
the elimination policies.
3. What are the largest
problems and challenges in the control of the disease?
- Insufficiency knowledge on:
- Transmission process of the disease.
- Recidivation occurrence.
- Resistance occurrence.
- Magnitude of adverse effects of medications used
for Hansen’s disease.
- Needs of Hansen’s disease patients’
on post-discharge period.
- Prevention strategies and rehabilitation at different
complexity levels.
- Information, education and communication strategies
for Hansen’s disease.
- Limitation of therapeutic arsenal.
- Lack of tools for diagnosis.
- Insufficient standardization of the
classification criteria for operational diagnosis.
- Evaluation of the decentralization
process in Hansen’s disease.
- Obstacles for sustainability of the
decentralization process for basic attention.
4. Which activities of
R&D&I would be necessary to face these problems
and challenges?
- Development of:
- New diagnosis tests for Hansen’s
disease.
- New tests markers and predictors
of Hansen’s disease reaction.
- New markers of recidivation and
resistance to medications.
- New markers of genetic susceptibility.
- New control strategies of Hansen’s
disease.
- Studies on:
- Transmission chain of Hansen’s
disease.
- Identification of risk groups.
- New drugs for treatment of Hansen’s
disease and its reactional states.
- Magnitude of adverse effects of medications
used in Hansen’s disease.
- Co-morbidities and mortality in Hansen’s
disease.
- Tests based on molecular biology
for diagnosis, resistance and transmission.
5. Which activities of
R&D&I would be necessary to face these problems
and challenges?
- Studies on:
- Determining the recidivation rate
and medication resistance in Hansen’s disease.
- Validation of criteria for operational
diagnosis.
- Validation of the epidemiologic
and operational indicators of Hansen’s disease
control.
- Sustainability of the decentralization
process of Hansen’s disease.
- Demands of Hansen’s disease
patients on post-discharge.
- Prevention and rehabilitation strategies
at different levels of complexity.
- Information, education and
communication strategies for Hansen’s disease.
- Implementation of:
- Tests already available for Hansen’s
disease diagnosis.
- Strategies for Hansen’s disease
control in primary health care attention.
- Effort for developing operational
research.
6. Which activities of
R&D&I are already in process? Are there new opportunities?
- Serologic methods for diagnosis and
identification of risk groups.
- Methods for typing the genomic variability
of the bacillus.
- Non-human sources of transmission (armadillo,
water).
- Development of skin testing based on
genomics.
- New diagnosis tools: PCR and nanotechnology.
- Detection of early neural injury through
new diagnosis methods.
- Other studies to which the group
(at the time) did not have access.
7. What would be the activities
of R&D&I in which the neglected diseases program
would have a comparative advantage of performance, in comparison
with already existent programs?
- Program aimed to neglected diseases, with a limited
number of participant diseases, which makes it possible
to prioritize investment aimed to public health.
- Innovation of strategies aimed to services and implementation
of its products, with a research-service interaction.
8. What should be the
specific priorities of constant R&D&I of the next
call for bid of Decit?
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 diseases and its reactions.
- Evaluation of strategies for
control of Hansen’s disease in primary health care
attention.
Recommendations forwarded to
Decit on funding strategies
- Medium- and small-size projects.
- Support for inter-institutional projects,
prioritizing research-control interaction, including emerging
groups.
- The needs pointed out by the Secretariat
of Health Surveillance were approached by the group, which
considered that the priorities within this document address
some of the needs presented by the Ministry.
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