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Qualification of Biomarkers for Drug Development in Organ Transplantation
Author(s) -
Burckart Gilbert J.,
Amur Shashi,
Goodsaid Federico M.,
Lesko Lawrence J.,
Frueh Felix W.,
Huang ShiewMei,
CavailleColl Marc W.
Publication year - 2008
Publication title -
american journal of transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.89
H-Index - 188
eISSN - 1600-6143
pISSN - 1600-6135
DOI - 10.1111/j.1600-6143.2007.02063.x
Subject(s) - medicine , drug development , transplantation , organ transplantation , intensive care medicine , biomarker , drug , clinical trial , biomarker discovery , clinical study design , bioinformatics , pharmacology , biology , biochemistry , proteomics , gene
The drug development process is dependent upon having established end points for measuring drug efficacy and adverse effects. New drug development in organ transplantation suffers from having end points which are either outdated or which do not serve the purpose of addressing the current critical drug therapy problems. Numerous biomarkers have been examined in organ transplantation, but almost all would be classified as exploratory for drug development purposes. Some of the possible pathways out of this dilemma include investigator‐ or consortium‐initiated research that would qualify the biomarkers as either probable or known valid biomarkers, help in identification of new end points in transplantation and their associated biomarkers, co‐development of a new biomarker and drug for transplantation and the use of new clinical trial design methods which facilitate enriched or stratified transplant patient populations. With new biomarkers and new study design methodologies for drug development, improvement in the drug development process for transplantation is a real possibility that the transplant clinical and research community can help to bring about.