Data oddities mark Russian trials

As China has been to drug manufacturing (think heparin), so Russia is becoming to drug development. Management needs to scrutinize the data-collection processes of clinical trials conducted there.

Medivation, working on an Alzheimer's drug, chose Russia for clinical testing because the drug was already approved there as an antihistamine. Positive data from the Alzheimer's drug trial earned an FDA nod to continue testing, as well as a multi-million dollar payment from Pfizer.

But a global Phase III trial yielded starkly different results; in fact, efficacy was measured in the trial outside Russia to be more than an order of magnitude poorer, just barely beating placebo performance.

Novelos Therapeutics had a similar experience. Its lead candidate showed impressive lung-cancer survival rates in a controlled Russian Phase II study, but a global Phase III test yielded no statistical significance. Likewise, Antigenics' cancer vaccine approved for kidney cancer in Russia failed a global Phase III trial.

- read the article

Sponsored By Metabolon

Five Translational Insights Key to a Successful First-in-Human (FIH) Study – Metabolite-Based Biomarker Discovery and Validation

Translational success rates from pre-clinical animal studies to human clinical trials remain frustratingly low. Learn how metabolomics helps you bridge between the theoretical & practical, between the function & actual activity of your drug molecule to get you closer to the phenotype, sooner.