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Decisions made by drug regulatory agencies require a high level of expertise in statistical methodologies. Without urgent efforts to enhance the level of such expertise in European regulatory agencies, there is a risk that they will not be able to meet emerging challenges such as quantitative modelling of benefit–risk profiles, wider use of innovative trial designs and greater public transparency of clinical trial data.
Cancer Research UK launched a bold scheme in 2006 to give second chances to industry's de-prioritized compounds. Its first two projects have now run their course, with varying degrees of success.
John P. A. Ioannidis, Professor of Medicine, Health Research and Policy and Statistics at Stanford University, discusses his latest plans to tackle irreproducibility in science.
Analysis of the value of new drug approvals over the past two decades, together with spending by industry on research and development (R&D), indicates that the R&D productivity for the industry overall has moved back towards a sustainable level, driven by several companies that are substantially outperforming the average.
Inhibiting bromodomains — which are small interaction modules on proteins that assemble acetylation-dependent transcriptional regulatory complexes — could be a way to alter the expression of disease-promoting genes. Here, the authors highlight recent developments in the discovery of small-molecule bromodomain inhibitors and discuss how they might be used in cancer, inflammation and viral infection.
The Notch signalling pathway, which is crucial for the development and homeostasis of most tissues, has been linked to a range of diseases, including cancer. Andersson and Lendahl discuss where and how to intervene therapeutically in the Notch signalling pathway, highlighting current achievements and remaining obstacles.
The cytokine interleukin-21 (IL-21) regulates immune responses and has potential therapeutic relevance in diseases including cancer, viral infections, autoimmune diseases and allergies. Spolski and Leonard describe our current understanding of IL-21 biology, and discuss progress in harnessing this knowledge therapeutically, including clinical trials of IL-21 itself and molecules that block IL-21 signalling.
