"Enrichment Designs"
If biomarkers can reliably identify individuals with a high
probability of response to a therapy, trials could focus on
such patients. Conducting a trial in a potential high response
subgroup is called enrichment. Enriched trials have greater
power and could result in therapies targeted at those most
likely to benefit. Enrichment raises some difficult issues:
• How will data on the marker status of potential
trial enrollees be used in trial design?
• How much data are needed on the un-selected
population?
• What types of retrospective subset analyses are
valid (e.g., what can be reliably learned from
subgroup analyses that were not prespecified in
the original trial design)?
fda.gov
So, maybe "Enrichment" is the word to add to google
searches and such.
Also thought the following was interesting...
I take for granted the efficacy of vaccines for my kids,
and yet at the same time I very much doubt the efficacy
of my yearly flu shot!
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Proving the Efficacy of Preventive Vaccines.
Proving the efficacy of preventive vaccines can be
particularly costly, because of the need to study the
disease-preventing effects of candidate vaccines in
large numbers of subjects for long periods of time. If
surrogate markers of protection, such as measurements
of the immune response to vaccines, could be correlated
with protection from disease, vaccines against influenza,
SARS, West Nile Virus, smallpox, hepatitis C, and parasitic
infections could be developed more quickly and more cost
effectively. |
