title: Lost in translation: problems and pitfalls in translating laboratory observations to clinical utility.
abstract: Developments in whole genome biotechnology have dramatically increased the opportunities for developing more effective therapeutics and for targeting them to patients who require them and who can benefit from them. This can have profound benefits for patients and for the economics of health care. There are, however, many obstacles to overcome in achieving this revolution. The effectiveness of translational research in oncology is seriously limited by many factors, both structural and scientific. Some of the obstacles involve the failure of biomedical organisations to develop and fund new models of inter-disciplinary collaboration needed to attract and support the best and brightest quantitative scientists to predictive medicine. Many of the challenges are scientific, requiring paradigm changes in the way drugs are developed and in the way clinical trials are designed and analysed. Some of these issues are addressed here, specifically in the context of developing molecular diagnostics in a manner that moves retrospective correlative science to prospective predictive medicine.
authors.affiliation: National Cancer Institute, Division of Cancer Treatment and Diagnosis, Bethesda, MD 20892, USA. rsimon@nih.gov
authors.forename: Richard
authors.initials: R
authors.lastname: Simon
mesh_terms: D014408:Biomarkers, Tumor / Q000378:metabolism; D035843:Biomedical Research / Q000379:methods / Q000639:trends; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000628:therapy; D004059:Diffusion of Innovation; D005260:Female; D020869:Gene Expression Profiling / Q000379:methods; D006801:Humans; D011379:Prognosis
chemical_list: D014408:Biomarkers, Tumor