CRfocus clinical research podcast

Interview: Simon Day on subgroup analyses & bridging studies

comment@crfocus.org (The Institute of Clinical Research) — Wed, 02 May 2012 12:58:52 +0000

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 the ICR Annual Conference in London on May 14th 2012, where he will speak on the transferability of foreign data, asking whether the current standard methods of subgroup analyses and bridging studies provide sufficiently robust information when looking to apply clinical trial data generated in one region to prescribing decisions elsewhere in the world.

https://crfocus.wordpress.com/wp-content/uploads/2012/05/20120502_interview_simon_day.mp3

Hugo Cervantes of Deloitte on reversing the decline of IRR in pharma R&D

comment@crfocus.org (The Institute of Clinical Research) — Tue, 29 Nov 2011 12:02:52 +0000

https://crfocus.wordpress.com/wp-content/uploads/2011/11/crfocuscervantesinterviewapproved.mp3

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.

Interview: Steve Read on Inspirational Leadership

comment@crfocus.org (The Institute of Clinical Research) — Thu, 03 Nov 2011 11:01:44 +0000

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.

https://crfocus.wordpress.com/wp-content/uploads/2011/11/20111028-steve-read-on-inspirational-leadership.mp3

Interview: Dr Jonathan Sheffield OBE (part 3 of 3)

comment@crfocus.org (The Institute of Clinical Research) — Fri, 02 Sep 2011 14:20:37 +0000

https://crfocus.wordpress.com/wp-content/uploads/2011/09/20110811-sheffield-interview-part-3.mp3

Interview: Dr Jonathan Sheffield OBE (part 2 of 3)

comment@crfocus.org (The Institute of Clinical Research) — Fri, 02 Sep 2011 14:13:18 +0000

https://crfocus.wordpress.com/wp-content/uploads/2011/09/20110811-sheffield-interview-part-2.mp3

Interview: Dr Jonathan Sheffield OBE (part 1 of 3)

comment@crfocus.org (The Institute of Clinical Research) — Mon, 15 Aug 2011 14:19:24 +0000

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).

Academy of Medical Sciences review: Interview with Prof Sir Michael Rawlins

comment@crfocus.org (The Institute of Clinical Research) — Mon, 15 Aug 2011 09:23:14 +0000

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.

How Much Does a New Medicine Really Cost?

comment@crfocus.org (The Institute of Clinical Research) — Mon, 15 Aug 2011 09:18:39 +0000

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.

News discussion podcast 20110209

comment@crfocus.org (The Institute of Clinical Research) — Mon, 15 Aug 2011 09:12:36 +0000

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

Multinational studies need multinational professionals

comment@crfocus.org (The Institute of Clinical Research) — Mon, 15 Aug 2011 09:03:09 +0000

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.