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Personalized Medicine - Pharmacogenomics Model in Clinical Trials
Transcript of Personalized Medicine - Pharmacogenomics Model in Clinical Trials
Long term sample storage & handling
Electronic genetic data transmission
Possible genetic discrimination
Return of study information
Public view & understandings
What is pharmacogenomics (PGx)?
Study of how genes
(DNA and RNA)
affect a person’s response to drugs.
Hypothesis developed after protocol initiation
and not described in original protocol
PGx analysis has no influence on trial design
analysis is retrospectively defined
PGx analysis generally not included in CSR,
and can be conducted at some point after CSR is authored
Analysis conducted on optional, future-use samples.
What is pharmacogenetics (PGt)?
Personalized Medicine: Pharmacogenomics Model in Clinical Trials
- Mayo Clinic Proceedings, 2014
One Size Fits All
Applications of PGx
in terms of clinical endpoints
Where are we now in terms of PGx?
Study of how
sequence affect a person's response to drugs
However, both terms are often used interchangeably
Biomarker Validation Strategy
Companion Diagnostics Development
Where can we go from here?
Developed hypothesis described in protocol
(can be exploratory)
PGx can influence trial design
(eg. stratification based on gene status)
PGx analysis included in CSR
Analysis conducted utilizing samples collected from
all or majority of patients in the trial
Trial Design & Protocol Development
optional vs. mandatory participation
genomic endpoint are already known vs. will only be defined over the course of the trial according to emerging clinical issues
samples will be analyzed within the context of the trial only vs. will also be retained for future research
Cost vs Savings
Vendors & Key Personnels
Preliminary safety & PK data
Defined endpoint based on genomics
Identify responder subgroups
Determine optimal dose
In terms of utilization in...
Genomic Data and Sample Coding Categories