2. Before knowing what translation Research is, it is
necessary to provide definition of other biomedical
research sections so as to later demonstrate how
they’re all linked to Translation Research.
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3. Definitions:
What is biomedical (medical) research?
This is a broad area of science that:
- Seeks to find ways of preventing, diagnosing and treating
diseases that cause ill - health in humans and animals.
- It is multi-disciplinary in nature and includes, but not
limited to:- Biologists, Chemists, Physician Scientists,
Veterinarians, Bio-engineers, Computer Scientists,
Dentists, Technicians, Public health and health services
researchers.
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4. They carry out careful:
- Observations,
- Experimentation,
- Analyses,
- Development and evaluation of new medicines,
procedures, medical devices, and tests to diagnose,
prevent, treat and cure diseases.
What are the traditional major divisions of biomedical research?
- Basic (pre-clinical)
- Applied (Clinical)
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5. BASIC RESEARCH:
- This is concerned with development of fundamental scientific
knowledge;
- It expands our understanding of how cellular and molecular
processes in living organisms develop and function;
- Mechanisms of disease development and progression;
- It is not associated with short-term therapeutic or commercial
benefits.
- It is however associated with knowledge development
breakthroughs that may take decades to achieve; e.g.
- association of cholesterol and formation of arterial
atherosclerosis;
- association of the gene RPA4 with cancer cells.
- decreased levels RPA4 increased likelihood of
development of cancerous cells.
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6. CLINICAL OR APPLIED RESEARCH:
Definition according to NIH, US:-
It is research conducted with human subjects or materials of human origin -
tissues, specimens and cognitive phenomena for which an investigator or
colleague directly interacts with human subjects.
It includes:
Patient Orientated Research:
Involves a particular person or group of people or materials from humans.
The research involves:
- Mechanisms of human diseases,
- Therapeutic interventions,
- Early clinical trials,
- Development of new technologies.
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7. Epidemiological and behavioural studies:
These involve:
- Studies to investigate distribution of diseases and their
determinants;
- Factors that affect health and how people make health related
decisions.
Outcomes and health services research:
The studies involve:
Identification of the most effective and efficient interventions or
services.
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8. What prevents scientists working in the major divisions of research
from working together efficiently?
1. Basic scientists are not generally trained to think of the clinical
applications of their work.
2. The physical and cultural separation of basic and clinical research
departments in research institutes and universities do not
encourage interdisciplinary collaboration among the scientists.
3. Clinicians are not taught how to formulate research studies
from clinical observations.
4. Clinicians training does not make them appreciate the value of
basic sciences in the developments of new interventions - drugs,
medical devices, etc.
5. Public health scientists may not have strong basic or clinical
research backgrounds - but have community knowledge that
the other two groups lack.
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9. What should be done to improve working relationships
among these groups to provide quality healthcare?
TRANSLATION RESEARCH.
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10. What is Translation Research?
This is the area of research that harnesses knowledge from basic
sciences to produce new drugs, medical devices and treatment options
for patients and then ensure that these new products actually reach
the patients or populations for whom they’re intended and are given
correctly.
However, this translation is divided into 2 parts:
T1: This is the first translation block which is referred to “Bench-
to-Bedside” research where new knowledge from basic sciences
gained from laboratory experimentations is used to develop new
methods of disease diagnosis, drugs and disease prevention after
having been tested in humans. This is a bi-directional process, since
observations noted during the clinical phase of investigations can be
chanelled back to the laboratory for further research.
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11. T2: This is the second translation block which refers to translating
research findings into practice - ensuring that new
treatments, diagnostic tools, other research knowledge actually reach
the patients and populations they’re intended for and are
implemented correctly. This is also a bi-directional process since new
findings noted during the implementation among patients or the
community can be reported back to the scientists for further
investigations.
Why has Translation Research come to matter so much in recent
years?
Translation research has always taken place.
However, over the years, there has been a proliferation of basic
research data, but there has been no corresponding development of
clinically useful products being developed for improvement of human
health.
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12. What have some countries done to solve the problem?
In their effort to translate available basic science discoveries and those
to emerge in the future, National Institutes of Health (NIH) started
translational research centres at its Institutes in 2006 and launched
Clinical and Translational Science Awards (CTSA).
It was expected to have created 60 such Centres by 1212, which they
did - NIH was spending 500,000 US dollars per year.
The UK invested £450 million over 5 year period in Translational
Research Centres.
Translation research took a significant budget of European
Commission’s 6 billion euro budget.
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13. It is evident that starting Translation Centres is a very expensive
exercise that can be ill-afforded by developing countries which are still
struggling to develop fundamental systems of both basic and clinical
research.
The developing countries will have to devise a different model for
translation research.
Developing new centres within existing research infrastructure is not
realistic and sustainable for these countries. Their options probably lie
with doing translation research within the existing
infrastructure, forming collaborative teams from both basic research
and clinical research.
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14. What is the composition of Translation Research teams like?
Translating findings from basic sciences to clinical studies to T1 and T1
clinical findings to T2, enhancing the adoption of best practices in
health institutions and the community, are not automatic processes.
T1 and T2 studies only share a common name - Translational Research.
However, their goals, settings, study designs and investigators differ.
However, there has to be unrestricted interactions between the clinical
and basic research scientists to facilitate the conduct of translation
research within research institutes and universities.
Translational Research Team Composition:
Translational research is a collaborative team effort. One individual
cannot succeed in the venture.
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15. T1 Research requires:
- Mastery of molecular biology, genetics, basic pharmacology
and other relevant basic sciences, trained clinical scientists,
data documentation specialists, appropriate computer
software for data analysis.
- Evaluating the results in the context of global systematic
reviews.
T2 Research requires:
- Mastery of the implementation science of fielding and
evaluating interventions in the community.
- Disciplines that inform the design of such interventions -
clinical epidemiology, evidence synthesis, communication
theory, public policy, financing, organisation theory, systems
re-design.
- Data Documentation Specialists - Appropriate data entry
software and search engines to access systematic reviews.
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16. Team Composition:
Multidisciplinary professionals, laboratory based investigators, clinical
investigators, public health specialists, biostatisticians, data
managers, computer specialists.
What are some of the challenges to be expected during Translational
research knowledge - T2?
- Large volumes of research evidence being produced,
- Access to evidence sources,
- Time to read the evidence sources,
- Skills to evaluate and understand research evidence.
However, this challenge can be surmounted by:
- Developing clinical practice guidelines;
- Electronic libraries of health and public access
evidence sources.
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17. - Organizational barriers - lack of facilities and equipment, and
inappropriate skill mix.
- Peer group barriers - e.g. local standard of care not in line with
the desired practice.
Professional-patient interaction (communication).
- Community - socio-cultural barriers
- level of education
- Policy makers:
- Ignorance of the new quality improvement tools.
- Bias towards what is commonly known.
- Pricing of alternative tools.
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18. Does KEMRI engage in Translational Research?
KEMRI does engage in translational research, but not regularly and
consistently.
There are well developed structures to conduct robust translation
research.
There is very little interaction between basic research and clinical
scientists.
Whatever interactions exist are initiated informally by the concerned
scientists and do last for as long as the research that brought the
scientists together.
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19. However, some clinical researchers would occasionally interact with the
Ministry of Health if they’ve what they think can be used to manage or
prevent a certain illness - e.g. PVC10 by the Kilifi group - a vaccine against
pneumococcal lung infection in children.
Resistance of malaria parasites to chloroquin - led to change of policy to SP
(Fansidar).
Resistance to SP - Changed to COARTEM.
In conclusion, a robust platform for T1 and T2 translation research will lead to
the development of new tools to prevent, diagnose and treat illnesses.
It should begin with a few scientists - basic and clinical coming together to
form a research translation team at the Institute and then ensure its
sustainability by putting in place permanent structures for the purpose.
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