Translational medicine is the application of the results of medical research or those from biomedical sciences translated into medical practice. It is defined by the European Society for Translational Medicine as "an interdisciplinary branch of the biomedical field supported by three main pillars from the bench of a laboratory to the bedside of a patient, and community".
“The
goal of translational medicine is to combine disciplines, resources, expertise,
and techniques within these pillars to promote improvements in prevention,
diagnosis, and therapies. Accordingly, translational medicine is a highly
interdisciplinary field, the primary goal of which is to combine assets of
various natures within the individual pillars in order to improve the global
healthcare system significantly. Translational medicine is a rapidly growing
discipline in biomedical research and aims to expedite the discovery of new
diagnostic tools and treatments by using a multi-disciplinary, highly
collaborative, "bench-to-bedside" approach. Within public health,
translational medicine is aimed at ensuring that proven strategies for disease
treatment and prevention are actually implemented within the community. One
prevalent description of translational medicine, first introduced by the
Institute of Medicine's Clinical Research Roundtable, highlights two roadblocks
(i.e., distinct areas in need of improvement): the first translational block
(T1) prevents basic research findings from being tested in a clinical setting;
the second translational block (T2) prevents proven interventions from becoming
standard practice”
In
other words, to make it simpler to understand for readers, translational
medicine bridges the gap between laboratory research and patient care by
integrating discoveries in the lab into practical treatments and public health
strategies. It involves three key pillars: laboratory research (bench),
clinical application (bedside), and community health impact. The aim is to
overcome the "T1" and "T2" barriers that hinder progress
from research to clinical practice and from clinical breakthroughs to
widespread use.
We can
consider some additional aspects of the 3 pillars of translational medicine.
First
is basic research in the lab bench. This includes studies at the molecular and
cellular levels that uncover new mechanisms of diseases, identify biomarkers,
and discover potential therapeutic targets.
Second,
are clinical trials (bedside of patients). Translational medicine
prioritizes transforming laboratory findings into clinical trials to test the
efficacy, safety, and viability of new treatments or diagnostics.
Third,
is public health and community. A critical goal is to ensure that
validated clinical strategies are implemented in real-world healthcare systems.
This is where public health policies, healthcare delivery systems, and
education play vital roles.
What
are the translational research phases (T)? We shall break them into 5 phases.
T0:
Basic research, focusing on understanding disease mechanisms.
T1:
Testing discoveries in clinical trials, focusing on bringing innovations to
human subjects.
T2:
Clinical practice application, implementing proven treatments into clinical
care.
T3:
Investigating how treatments are applied at the community or population level.
T4:
Analysing health outcomes and optimizing strategies for public health
implementation.
Let me
give you three examples of Translational Medicine in action
1. Cancer
Research: Translational medicine has been crucial in transforming genetic and
molecular research into personalized cancer therapies (e.g., targeted therapies
or immunotherapies).
2. COVID-19 Vaccines: The rapid
development of mRNA vaccines for COVID-19 illustrates the power of
translational research. Basic molecular biology research on RNA technology
translated quickly into clinical trials and widespread immunization.
3. Stem Cell Therapies: Ongoing work in
regenerative medicine uses translational approaches to develop stem cell-based
treatments for a range of diseases, including neurodegenerative disorders and
heart disease.
What
about the role of technology in translational medicine?
Artificial
Intelligence (AI) and big data analytics are becoming increasingly crucial in
accelerating translational medicine by improving patient data analysis,
identifying treatment patterns, and predicting outcomes.
By
advancing the integration of scientific discoveries with medical practice,
translational medicine holds great promise for improving healthcare on multiple
fronts.
Having
explained that, I am afraid a lot of medical and clinical research has been
done worldwide, and the results published in scientific journals.
The
question we ask is, why are these results that are frontiers of new knowledge
in medicine not used?
The gap
between medical research and clinical practice, despite the wealth of knowledge
being published, is a complex issue, and several factors contribute to why
these groundbreaking results are not always immediately or widely implemented
in clinical settings.
I shall give at least nine (9) reasons for
this.
1.
Translational Blocks (T1 and T2)
T1
Block. Research findings often don’t move from the laboratory to clinical
trials due to difficulties in translating experimental results into practical
therapies. Many discoveries, even promising ones, may fail when tested in
humans, as the human body can react very differently than model organisms or in
vitro experiments.
T2
Block. Even when a treatment is proven effective in clinical trials, the
process of integrating it into standard medical practice is slow. This is
partly because healthcare providers may lack the resources, training, or
support to adopt the latest innovations.
2.
Regulatory and Safety Requirements
Clinical
Trials. Before a new treatment or diagnostic tool can be widely used, it
must go through multiple phases of clinical trials to demonstrate its safety
and efficacy. These trials are time-consuming and expensive, often taking years
or even decades.
Regulatory
Approvals. Once clinical trials are successful, therapies must be approved by
regulatory agencies such as the U.S. FDA, EMA in Europe, or other
country-specific authorities. The approval process can be lengthy, adding
further delay.
Safety
Concerns. There is an emphasis on safety, meaning many promising treatments
must be thoroughly vetted for potential side effects, especially long-term
ones, before they can become part of standard care.
3. Cost
and Accessibility
High
Costs. Even if a new treatment or technology has been proven effective,
the cost of adopting it into clinical practice can be prohibitive. New drugs or
therapies can be expensive, and not all healthcare systems or patients can
afford them, leading to unequal access.
Infrastructure.
Some innovations require new infrastructure, training, and equipment that many
healthcare systems, especially in lower-resource settings, may not have.
4. Lack
of Clinical Guidelines
Slow
Update of Guidelines. Clinical guidelines are developed by medical associations
and other expert groups, often taking a conservative approach to ensure new
findings are robust and broadly applicable. It can take years for guidelines to
be updated with the latest research.
Evidence
Threshold. For research findings to be integrated into clinical guidelines,
there usually needs to be a critical mass of evidence supporting their efficacy
and safety. Single studies or small trials often aren’t enough to warrant a
change in standard practice.
5.
Physician Awareness and Resistance
Limited
Knowledge. Healthcare providers may not always be aware of the latest research.
While some doctors stay current with new studies, others may not have time to
follow the flood of new publications.
Clinical
Conservatism. Many physicians are cautious about adopting new treatments,
particularly if existing ones are effective. They may wait until more extensive
evidence or guidelines confirm the new approach as better.
Training
and Experience. Adopting a new therapy might require specialized training or a
shift in clinical practice, which can create resistance, particularly among
physicians who are more experienced with established methods.
6.
Variability in Research Quality
Reproducibility
Issues. Not all research results are reproducible or applicable to a broad
population. There is increasing awareness that some published studies may not
hold up when tested on a larger scale or in different settings, leading to
scepticism about integrating them into clinical practice.
Conflicting
Evidence. For some areas of research, different studies may yield
conflicting results. This can cause uncertainty, and clinical practitioners may
hesitate to adopt new findings until a clearer consensus emerges.
7.
Ethical and Social Considerations
Ethical
Approval. Ethical concerns regarding patient safety and treatment risks also
slow down the implementation of new therapies, as they require careful
consideration of risks versus benefits.
Public
Perception. New treatments, especially those involving controversial techniques
(e.g., gene editing, stem cells), may face resistance from patients or
communities due to ethical concerns or misunderstandings.
8.
Health Policy and Insurance
Insurance
Coverage. Even if a treatment is approved, it may not be covered by health
insurance, limiting its availability to patients. Insurers may wait for further
evidence or cost analyses before agreeing to cover a new therapy.
Healthcare
System Integration. For public health interventions, there may be challenges in
adapting healthcare systems to accommodate new approaches, particularly in
resource-poor settings.
9.
Publication and Data Sharing Delays
Publication
Delays. Even after research is completed, there can be delays in publication.
The peer review process, while essential for ensuring quality, takes time,
meaning findings might not be disseminated promptly.
Data
Accessibility. Sometimes, research findings are published but not easily
accessible due to paywalls, making it harder for clinicians, especially in less
well-funded institutions, to stay updated.
I shall
continue to write on this subject later under:
Translational Medicine: Bridging the Gap (Part 2) where we shall look at the pit falls of translational medicine translated into conventional allopathic medicine commercialized by Big Pharma into the world of other emerging systems of medicine
Stay tune
(To be
continued)
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