EMA releases paper on biomarker use for comment
The European Medicines Agency (EMA) has put out for consultation a reflection paper on the use of pharmacogenomic biomarkers as patient selection and treatment stratification tools in drug development, according to PharmaTimes.
A draft of the paper was agreed by the Pharmacogenomics Working Party of the EMA’s Committee for Medicinal Products for Human Use (CPMP) in March and adopted by the CHMP. The deadline for comments is Nov. 25, 2011.
The paper on methodological issues with pharmacogenomic biomarkers in relation to clinical development and patient selection discusses the role these markers can play in predicting which patients are likely to benefit from a particular medicine or which may be susceptible to side effects.
The availability of techniques facilitating the study of the human genome has led to an “exponential increase” in research into genomic biomarkers (GBMs) for disease diagnosis, as markers of either prognosis or response to treatment, the paper said.
It said GBMs should offer “the advantage of improved specificity and reduction of heterogeneity that is an integral part of phenotypic population grouping.”
This characteristic is seen as highly attractive in drug development, given the potential for GBMs to reduce attrition and development costs through improved understanding of mechanisms of action, better awareness of potential adverse events and use of novel development strategies in pre-clinical and clinical trials.
GBMs may have a wide range of applications in clinical drug development, the paper said, including patient selection; prognoses; stratification of patient groups or treatment strategies; early evaluation of treatment effects, including adverse reactions; pre-defined sub-group analyses; and enabling novel trial designs that “might not be possible otherwise due to heterogeneity of clinical characteristics.”
GBMs could also play a valuable role in risk management strategies, including risk minimization, by prior identification of patients susceptible to severe adverse effects, the paper said.