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The Importance of Stratification in Clinical TrialsDiscoverPrint offers pharmaceutical companies the opportunity to include patient stratification based on reliable identification and validation of gene expression profiles to differentiate between responders and non-responders. By evaluating how an individual's genetic make-up impacts his or her response to a drug, this 'pharmacogenomics' approach, included in the design of a clinical trial, enables patient selection on the basis of an appropriate gene expression profile. Likely non-responders can be excluded, thereby increasing the percentage of potential responders and, thus, improving the chances of meeting the trial's endpoint. A case in pointThe importance of patient stratification in today's clinical development has been clearly demonstrated in a paper (Journal of Clinical Oncology, Vol 22, No.5 [March 1] 2004: pp759-761) by Jose Baselga from the Val d'Hebron University Hospital, Barcelona, Spain in which he wrote about the failure of the Iressa (gefinitib) phase III trial to add clinical benefit to conventional chemotherapy in non-small-cell lung cancer (NSCLC) despite promising phase II trial results. Dr. Baselga compared this to the successful phase III trial for Herceptin (trastuzumab) on breast cancer and concluded:"In an era where cDNA arrays and proteomic technology are becoming increasingly available and gene expression profiles in the tumor are used to identify molecular signatures of prognosis and prediction of response to conventional chemotherapy [...] it seems reasonable that a "no tissue, no participation" rule should be strongly considered in trials with targeted agents." - Dr. Bagelga, Barcelona If you are interested in collaboration, or in-licensing, please contact: BusinessDevelopment@Agendia.com If you are interested in participation in anexisting trial or for more information on new trial collaboration, please contact us at clinicaltrials@agendia.com. |
