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L12A - Bench to Bedside: Transnational Medicine Understand and critically…
L12A - Bench to Bedside: Transnational Medicine
- Understand and critically appraise the methods and the description of statistical content of medical research studies.
- Develop familiarity with the spectrum of Translational Medicine
- Understand the underlying premise for each phase of translational research from T0 to T4.
- Appreciate that the definitions are in continuous evolution, and may be different for different disciplines.*
What Is Translational Medicine
Definition
Process of turning observations in the lab into interventions that may be implemented in community to improve health outcomes
Traslational Research is in continuous evolution (Once two phases, now five phases)
By involving a multidisciplinary collaboration, the ultimate goal is to accelerate the effective use of medical research to inform healthcare
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Stages of Translation medicine
Each stage feeds into the next stage and feeds back into previous stages.
Dynamic and integrated insights.
T0 : Basic Research
Fundamental to all subsequent stages of research
- Utilises Basic Biomedical research.
- Use of animal studies/cultured cells
- Not including interventions with human subjects
- Technological advances in any other stage of TR builds upon our basic understanding (Feed back loop makes innovation possible)
Example: Trans. Res. for Breast Cancer
- Basic research question #1 Are there specific gene mutations associated with breast cancer?
T1 : Translation to Human
- Involves translation of basic science discoveries to humans and human disease – pre-clinical
- Requires proof of concept studies - scientists use model interventions
- I.e. testing a new anti-cancer drug on tumour cells in a petri dish
- Need to ensure the benefit of these interventions
- Focus on new methods of diagnosis, treatment and prevention
Example: Trans. Res. for Breast Cancer
Is there an association between BRCA mutations and breast cancer?
T2 : Translation to patients
- Movement of discoveries into patients; Early phase clinical testing
(Phase 2 & 3 trials)
- Testing for Toxicity/ Efficacyon people (healthy + ill)
- The goal of many clinical trials is to obtain data to support regulatory approval for an intervention. Achieve clinical application
Example
What is the positive predictive value of BRCA mutations in at-risk women?
T3 : Translation to practice
Involves the adoption of interventions that have been demonstrated to be useful in the research setting into routine clinical care for the general population
- Dissemination
- Implementation
- Includes the evaluation of the results of clinical trials and asking new questions
Example
QU: What proportion of women who meet the family history criteria are tested for BRCA (dissemination) and what are the barriers to testing (implementation) ?
T4: Transaltion to Community
- Population based outcomes (Global population included)
- Ultimate goal everyone is treated - global dissemination
- Researchers use studies to determine effects of disease and what can be done to prevent, diagnose and treat them
- T3 and T2 dissemination strategies is a key part of this
- Assessing risks and impacts of policy and change (morbidity, mortality, benefits etc)
Example
The type of question may emerge; Does BRCA testing in asymptomatic women reduce breast cancer incidence or improve outcomes-
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Barriers to Translation Research
- Clinical Research Efficiency
- Collaborations and Partnerships
- Effective Dissemination
- De-risking Therapeutic Development
- Predictive Efficacy/Toxicology
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Effective Dissemination
Availability
Data needs to be made publicly available to spur innovation and discovery
Data from all stages of research mustbe released (pulication bias
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Requirements of getting from T0-T4
Team of multidisciplinary individuals working in synergy
- Scientists
- Practitioners
- Statisticians
- Ethics
Etc
- No single specialist has the ability to embark on the translational journey alone
- Team approach will be a paradigm shift in how we view and execute translational research
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Preclinical Research => Intellectual Property => Finance => Regulatory Issues => Clinical Research
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