Imaging biomarker roadmap for cancer studies.

Imaging biomarkers (IBs) are integral to the routine management of patients with cancer. IBs used daily in oncology include clinical TNM stage, objective response and left ventricular ejection fraction. Other CT, MRI, PET and ultrasonography biomarkers are used extensively in cancer research and drug development. New IBs need to be established either as useful tools for testing research hypotheses in clinical trials and research studies, or as clinical decision-making tools for use in healthcare, by crossing 'translational gaps' through validation and qualification. Important differences exist between IBs and biospecimen-derived biomarkers and, therefore, the development of IBs requires a tailored 'roadmap'. Recognizing this need, Cancer Research UK (CRUK) and the European Organisation for Research and Treatment of Cancer (EORTC) assembled experts to review, debate and summarize the challenges of IB validation and qualification. This consensus group has produced 14 key recommendations for accelerating the clinical translation of IBs, which highlight the role of parallel (rather than sequential) tracks of technical (assay) validation, biological/clinical validation and assessment of cost-effectiveness; the need for IB standardization and accreditation systems; the need to continually revisit IB precision; an alternative framework for biological/clinical validation of IBs; and the essential requirements for multicentre studies to qualify IBs for clinical use.Development of this roadmap received support from Cancer Research UK and the Engineering and Physical Sciences Research Council (grant references A/15267, A/16463, A/16464, A/16465, A/16466 and A/18097), the EORTC Cancer Research Fund, and the Innovative Medicines Initiative Joint Undertaking (grant agreement number 115151), resources of which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/2007-2013) and European Federation of Pharmaceutical Industries and Associations (EFPIA) companies' in kind contribution

The RTS,S vaccine: Will it prove or fail to be the holy grail of malaria prevention?

Malaria claims the lives of approximately a million people per year, plus causes suffering in hundreds of millions. It has drastic socioeconomic impacts on endemic countries and has been the focus of global health initiatives for decades. Early attempts to eradicate malaria failed; however, increased interest in existing control measures has led to a second attempt and has been met with much support especially for the prospect of a vaccine. Knowledge of the malaria parasite’s complex lifecycle and transmission rates combined with ever-improving immunological understanding has produced a host of vaccine candidates. Amongst these the most notable is RTS,S which has seen a long development process and shown much promise, recently progressing into phase III clinical trials. Nevertheless RTS,S still faces a number of obstacles, and doubt has been cast over its potential. While the future of RTS,S is not certain, it is still likely to play a role in our ongoing fight against malaria