Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : The thread of life -- Ignore unavailable to you. Want to Upgrade?

To: Mike McFarland who wrote (1221)	1/5/2007 9:37:17 PM
From: Mike McFarland	Read Replies (1) \| Respond to of 1336

"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! ------ 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.