31 Other initiatives at the European level include a revision to

31 Other initiatives at the European level include a revision to the 2001 European Clinical Trials Directive, addressing concerns about its negative impact on translational research,32 33 and long-standing buy Topotecan financial incentives to develop drugs for paediatric use27 and orphan indications, which are now a significant and increasing proportion of all new drug approvals.34 35 Many of these policy initiatives are in

the initial stages of implementation, and though industry bodies have generally welcomed their introduction, other commentators have identified areas of improvement for industry itself, including reducing the numbers of late-stage failures through improved collaboration both with academia and between commercial developers,36 as well as improved trial design and better use of real-world registry data.23 In all cases, current actions and initiatives will have long lead times to impact, and will need thorough and careful assessment to ensure they deliver increasing numbers of

innovative drugs without unintended consequences on public health and health service delivery and affordability. Alongside this, commercial developers require a full and comprehensive understanding of what policymakers (including publicly funded health services, such as the NHS) and patients value in pharmaceutical innovation in order to direct their innovation efforts towards commercially viable end points. Understanding the interplay between the various stakeholders competing needs will be an important area for future research. Supplementary Material Reviewer comments: Click here to view.(157K, pdf) Author’s manuscript: Click here to view.(2.6M, pdf) Footnotes Contributors: AJS conceived the original study idea, and DJW and OIM contributed to the development of the study design and methods. OIM, AS and TG collected the data and carried out the initial analysis, while DJW advised on the classification of new drugs where required and directed further analysis.

All authors were involved in the interpretation of the results. OIM and DJW produced the initial draft of the paper, which was then circulated Brefeldin_A repeatedly to all authors for critical revision. DJW, AS, TG, OIM and AJS read and approved the final version. All authors had full access to all of the study data (including statistical reports and tables), and can take responsibility for the integrity of the data and the accuracy of the analysis. DJW is the guarantor. Funding: The study was undertaken as part of the research programme of the NIHR Horizon Scanning Centre (NIHR HSC). The NIHR HSC is funded by the National Institute for Health Research (NIHR). This article presents independent research funded by the NIHR.

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