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Enrichment and patient selection
Element
Challenges
Solutions
Molecular selection
Central screening
•
Archived tumor samples
requested
•
Return of molecular
information
•
Turnaround time variable
Local screening
•
Local screening not
reimbursed
•
Assay may not be validated in
CLIA lab
Activate molecular screening
programs national based or
locally supported using
validated multiplexed assays
(funding remain an issue)
Identification of rare subset
of patients
Screening costs while
number of eligible patients
with financial challenges to
keep many trial open with
less patients recruited
Support for screening
Multiplexed screening
Umbrella or basket protocols