Simon Day is a Statistical Expert at Roche Products, and is both Past President of the International Society for Clinical Biostatistics and Joint Editor of the Journal of the Royal Statistical Society. He was formerly Head of the Statistics Unit at the MHRA, and also sits on an ethics committee. Simon will be speaking at […]

A new report from Deloitte looks at the decline in Internal Rate of Return (IRR) across pharma R&D, and suggests that improving late stage success rates has a far greater impact than reducing cost or development times. We spoke to Hugo Cervantes, one of the leading contributors to the report, about what these findings mean, and what pharma can do to improve the situation, from closer collaboration to a sharper focus on value throughout the development process.

Steve Read is Managing Director of Adair International and the Helix Consultancy. Andrew Smith speaks with him about leadership in business and how professionals in the pharmaceutical industry can develop their leadership skills. Steve will be one of the presenters at the ICR Masterclass on Inspirational Leadership, to be held in central London on December 9th 2011. For more information, and to book your place, visit www.icr-masterclass.org.

Part one of our three-part interview with Jonathan Sheffield OBE, Chief Executive Officer of the National Institute for Health Research Clinical Research Network (NIHR CRN).

The Academy of Medical Sciences’ review of regulation and governance of clinical research, “A new pathway for the regulation and governance of health research”, was published early in 2011, making many radical proposals to streamline, simplify and improve the regulations, organisations and processes involved in conducting commercial and non-commercial clinical research in the UK. Andrew Smith interviews Professor Sir Michael Rawlins, who chaired the review.

The estimate for the cost of bringing a single new medicine successfully to market is generally accepted to be around $1b, based on study data published in 2003 and subsequently adjusted for inflation. However, a paper was published last month that reworks some of this same data, and suggests that the true cost might be much lower: close to $55m! This paper has been picked up by some media outlets and provoked something of a furore… and opened an interesting discussion about how such figures are calculated. Andrew Smith reports, and wonders whether the analysis should be updated from scratch.

Andrew Smith and Adam Jacobs discuss the background and implications of news stories from throughout the clinical research community, covering stories from January and early February 2011

In May's Viewpoint column, Andrew Smith argues that the globalisation of clinical research requires a new generation of manager, with awareness of global frameworks for regulation and governance of clinical trials, and expertise in the cross-border issues that make global studies significantly more complex than their single-country or even regional predecessors.