March 3, 2017

Genotyping/Resequencing in clinical trials?

I've been to a couple of seminar series in the last month that had something or partly to do with clinical trials data management.
The first one was on July 13th 2010 at Granta Park, Cambridge UK. The seminar was the occasion to announce the launch of the UK Clinical Trials Cluster, an initiative by Oracle and two of its partners, Pharmasol and Triumph Consultancy, to provide an on-demand, cloud-based, ready-to-use platform supporting one-off and multiple trials with regulatory validation. Apart from enquiring about their offering which looked quite impressive and cost effective I also took the opportunity to ask them about genotyping and resequencing data in clinical trials. These people have been setting up clinical trial data management system for well over 10 years, and so far not once have they been asked about dealing with such data, not even in future prospects.
The second event was on August 3rd, 2010 at “Future developments in genome resequencing” part of the seminar series on “Statistical Challenges Arising from Genome Resequencing” held at the Isaac Newton Institute for Mathematical Sciences in Cambridge, UK. Matthew Nelson's talk from GSK was of particular interest as he emphasised how challenging it would be to do a proper pharmacogenetics study for efficacy or safety in early phase I, II or III due to the very small sample size of patients. In fact it seems that most of the research on pharmacogenetics happens in phase IV once a drug has already been approved and on the market.

Topics: Bioinformatics, clinical trials, genotyping, pharmacogenetics, resequencing