Biomarker Consultants | Late Phase
Updated: Apr 28
In late-phase trials, there are two types of biomarkers used to evaluate or predict outcomes - prognostic and predictive.
Overall, molecular and functional biomarker development remains a very active area of current investigation and commercialization. These biomarkers can serve as surrogate endpoints for therapeutic efficacy and are increasingly viewed by the Food and Drug Administration as highly desirable.
Attractive features are:
Reduced trial size,
Shortened completion time, and
Biomarkers can also be extended to use as diagnostic agents, either as stand-alone probes or in combination with therapeutic drugs in order to stratify patients for treatment and outcome monitoring.
Also, previously developed and validated biomarkers can be applied to new therapeutic trials in order to reduce sample size and shorten the time to conduct a trial. Therefore, objective, quantifiable biomarker endpoints can significantly reduce data variability and generate early, statistically significant therapeutic effects and imaging standardization is essential for achieving this goal.
BioMolecular Imaging can identify the optimal imaging technology for you and assist your company in all aspects of standardized image acquisition and analysis.
Please read these articles by the Founder of BioMolecular Imaging, Dr. J. James Frost:
About BioMolecular Imaging
BioMolecular Imaging (BMI Consultants) is a molecular imaging and clinical trial consultancy owned and operated by Dr. J. James Frost M.D./Ph.D out of Baltimore Maryland. BMI has been involved with clinical, therapeutic & diagnostic imaging focused on Oncology, Brain, Biomarkers, Cardiology and Central Image Interpretations for over 20 years.
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