Applied Clinical Trials eBook - June 2014 - (Page 11)
ONCOLOGY
Translational Medicine and
Biomarkers
Holly Hilton, Rand Jenkins, and Steve Lobel
Transfer of knowledge between pre-clinical and
clinical research is necessary to deliver effective
medicines to patients.
T
ranslational medicine is the emerging discipline involving the translation of laboratory
findings into the design and implementation
of early-stage clinical trials. Translational
medicine focuses on translating pre-clinical
data from in vivo, in vitro, and in silico research
into the clinic to help design trials, determine
methods, and choose the biomarkers. In addition,
translational medicine uses the data from clinical studies to feed back into pre-clinical experiments to improve future drug discovery. Biomarkers are an essential piece of the translational
effort and critical to understanding an individual
patient's disease and response to experimental
treatments. Translational medicine uses a very
patient-driven approach to drug development
and is a result of the practical application of the
improvements made in biomarker discovery in
the era of personalized medicine.
Many pharmaceutical companies are introducing translational medicine depar tments
charged with the task of facilitating the transition of basic research into practical treatments
and clinical trials. These organizational changes
are based on the need for an improved, dynamic
exchange of information between late pre-clinical efforts and early stage clinical trials.
Traditionally, oncology has been at the forefront of the biomarker development and personalized medicine. However, as technologies
advance, fields such as neuroscience and immunological, inflammatory, and metabolic diseases
June 2014
are expanding their use of biomarkers for personalized medicine. Personalized medicine seeks
to identify individuals who will receive the most
clinical benefit and least harm from a specific
treatment by targeting genetic or other targets
associated with their disease. Enabled by technological advances and expansion of the use of
biomarkers, researchers can stratify patients into
disease subtypes and evaluate targeted therapies aimed at treating them. With the cost of
developing a successful drug typically exceeding
$1 billion, the need has never been greater to effectively translate pre-clinical research into the
clinic and learn from early stage clinical trials.
Phase 0
Over the past 10 years, advances in early phase
studies have focused on collecting and applying
more clinical pharmacology data sooner to inform dose determination, endpoint identification,
and patient selection in Phase II trials. Phase 0
trials are emerging, particularly in oncology, to
help translate pre-clinical research into humans
before Phase I. Phase 0 evaluations leverage the
incorporation of biomarkers to gain more information from first-in-human experience.
In Phase 0, microdoses of experimental drugs
are administered to volunteers. The dose is
expected to be well below toxicity and efficacy
points, but can be used to make an initial assessment of pharmacokinetics and pharmacodynamics effects. Positron emission tomography
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Table of Contents for the Digital Edition of Applied Clinical Trials eBook - June 2014
Applied Clinical Trials eBook - June 2014
Contents
Analyzing 2013 Oncology Trends to Predict 2014 Directions
New Road of Cardio-Oncology in Clinical Development
Partnering Early for Successful Oncology Drug Development
Translational Medicine and Biomarkers
Immunotherapy Clinical Trials in Melanoma
Patient-First Approach to Improve Oncology Clinical Trials
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