Survey: Investigational Medicinal Product (IMP) management at clinical trial sites

You are invited to participate in a survey (http://www.zoomerang.com/Survey/WEB22AH7WMBA6D) to assess common practice of Investigational Medicinal Product (IMP) management at clinical trial sites for trials sponsored by the pharmaceutical industry.  This covers both the sponsor and the site perspectives.

Through personal experience managing clinical trials, questions received whilst serving on the Institute of Clinical Research (ICR) GCP Forum Steering Committee and through auditing and quality management work over recent years, it is clear that there is no consistent approach to managing or monitoring IMP at trial sites.  Investigator teams and monitors are therefore subject to a multitude of practices, which can give rise to frustration on the part of both investigator/pharmacy teams and sponsors/monitors alike and potentially put clinical trial subjects at risk.

There are 44 survey questions, which should take about 15 minutes to complete.  The survey is anonymous and the results will be shared through publication in CRfocus and on the ICR website. It is hoped that this will lead to future discussions on IMP management best practice and at least provide a benchmark from which to improve clinical trial IMP management in the future.

To complete the survey now, visit http://www.zoomerang.com/Survey/WEB22AH7WMBA6D

If you do not have time to complete the survey yourself, please consider forwarding it to a friend or colleague who might also be interested (they do not have to be an ICR member).

Thank you for taking the time to read this request and, hopefully, for also completing the survey.

[Posted on behalf of Janice Hedgecock MSc MBA FICR MRQA, Director and Clinical Development Consultant, Greatspur Clinical Development Ltd]

Legislative Review or Window Dressing?

One of the biggest news stories this month has been the latest announcement of an independent review of the regulation and governance of UK clinical research. This was announced by Health Secretary Andy Burnham on March 25^th, and will be conducted by the Academy of Medical Sciences, which called for such a review in its January 2010 report “Reaping the rewards: a vision for UK medical science”. In announcing the review, Mr Burnham said “It is becoming increasingly clear that medical research is getting tied up in red tape. For research to flourish and provide the huge benefit it can give to the health and wealth of the country, it needs freedom from unnecessary bureaucracy and interference.”

This sounds rather familiar, having been the rallying cry behind reviews, reports and reorganisations going back at least as far as PICTf nearly a decade ago. This was followed by the UKCRC set of initiatives (now mostly under the banner of the NIHR) and more recently the Office for Life Sciences, which published its own report on “Delivering the Blueprint” only a few months ago. All of these have overlapped, in goals and activities, and all have provided incremental solutions to specific problems. It is hardly surprising that problems still remain to be solved, but people criticising the current systems should remember the ‘bad old days’ that preceded them.

So, is the AMS review going to provide that ‘Eureka!’ moment, delivering transformative recommendations that none of the previous review panels were able to come up with? Or is it the latest window dressing on the long-running series of evolutionary reforms that have fought against the gradual ‘decline’ of UK clinical research competitiveness, as medicine development has globalised, throwing the UK’s inbuilt demographic disadvantage into sharp relief? Of course, editorial hyperbole aside, the truth of the matter will be somewhere in between. However, well-meant as it is, there are some pretty fundamental problems with this particular review…

For a start, there is the long history of reviews in this area, including the ones described above, plus internal reviews conducted by the MHRA, Department of Health etc. over the past few years (and that continue to be ‘works in progress’). Is it really plausible that the ACM panel could spot a flaw or propose a solution that had been previously missed? Indeed, the overarching issue seems to be not so much with identifying specific problems as with translating them into generalisable solutions that can be applied usefully across commercial and non-commercial research, balancing provision for public confidence with available resources, and taken up in a homogenous way by a very heterogeneous set of organisations (and combinations of organisations).

Information about the review is still pretty sparse, but it has been described as “rapid”. However, the UK is a matter of weeks away from a General Election. Even if the AMS can produce its report before the election, it will surely be buried under the media froth on other campaign issues from the economy, crime and foreign policy to the environment, UK military operations overseas and MPs expenses! With the election widely expected to result in a change of government, there is no guarantee that the incoming politicians will choose to implement any of the AMS’ recommendations, and might even decide to commission yet another review on taking office…

Finally, a similar debate has been taking place on a pan-European level, with the European Commission already being more than 12 months into a discussion on the impacts of the Clinical Trials Directive, with broad consensus that something must and will be changed, and increasing acceptance that the text of the Directive itself might be part of that change. There is surely much wrangling to be done at this level over the next few years, but when this is complete, the UK legislation will have to change all over again as a result, regardless of any improvements brought about by the AMS.

So, although its aims are laudable, there is little practical value in commissioning this review now: it duplicates reviews that are already in progress, it’s unlikely to be able to solve the multi-level problems it’s designed to address, and the broader legislative environment is likely to change soon anyway! Sometime, somehow, further reform of UK clinical research regulation and governance is certain to take place, but the timing and context of this review appear certain to undermine any value that it could add.

Blogging from EFGCP conference on personalised medicine

On January 26th and 27th I will be blogging from the EFGCP Annual Conference, which this year has the theme “Aspects of Personalised Medicine for Society – a Challenge Yet to be Met”. From the main page about the conference:

For the past 50 years the development of new medicines has been highly successful. As a result, many diseases have been well treated – sometimes cured or at least their symptoms relieved. Success could be measured by the number of patients thus treated. However, such success had to be leavened by the frequency of side effects and it had to be recognised that potential success for an individual patient could be nullified by the unacceptability of such side effects. So attempts were made both to increase the efficacy of new medicines and to improve their tolerability; and, in parallel, it was realised that efficacy and tolerability of any given medicine varied between individual patients. The traditional tools for finding the right dose for most patients were randomized controlled clinical trials and post-marketing surveillance studies; but, recently, the recognition that the individual genetic profiles of patients could be identified in terms of their susceptibility to treatment with medicines as well as their susceptibility to the side effects of such medicines has enabled a paradigm shift towards the success of a new medicine. Knowledge about the individual genome has clearly opened up huge scientific opportunities, but accompanied by a significant need to identify, discuss and attempt to solve aspects of personalized medicine related to society as a whole. This conference will tackle the complex issues involved, including the ethics of providing confidential information arising from knowledge of the individual genome, associated economic factors, access to tailor-made treatment and how this should be prioritised. By means of a series of presentations by those experienced in handling these issues, and six interactive workshops, the EFGCP Annual Conference 2010 will aim to identify the challenges of personalized medicine in the context of society as a whole yet to be met. The various roles of all the stakeholders, from the bench-based scientist to the patient, will all be discussed in the interests of identifying the best possible treatments for the society of the future.

Further information about the conference, including how to register, can be found here. I will be posting almost-live from the conference to this site, and will also publish a more formal report in a future issue of Clinical Research focus (hopefully the March issue).

Table of Contents: CRfocus 20(11) – November 2009

This is the Table of Contents of Clinical Research focus 20(11) issue for November 2009. Members of ICR can click the links below to log in and read the full text of each article.

Features

Challenges of Inter-Organisation Projects: What Factors Lead Towards Success?

Matthew Theobald

Working with partner companies to define, execute and deliver a clinical research project can be a challenge at the best of times. So what is it that sets successful projects apart from those that struggle to get started or lose focus during their execution? Recent ‘project fractures research’ into this topic reveals that the root causes of project failure (or significant variance) don’t lie in the project management methodologies or structure. The root causes actually lie in the people factors, such as how they engage in projects. Matthew Theobald presents some useful insights into how projects fail, and suggests how they might be planned and managed better.

An Unacceptable Conflict of Interest? The PharmaTimes Great Oxford Debate

Les Rose FICR

Arguably the world’s foremost debating chamber, the Oxford Union was the scene of this annual event, which always addresses contentious issues for the pharmaceutical industry. The Motion for this year’s debate was: “This house believes that there is an unacceptable conflict of interest when pharma conducts trials on its own drugs”. Les Rose was there, and presents the main arguments for and against the motion, and reveals the (not unexpected) result of the evening’s vote.

How Will Personalised Medicine Have an Impact on Clinical Trials?

Abel Ureta-Vidal

How can genomics have an impact on the management of your clinical trials? With the growing understanding of genetic code within personalised medicine, could this signal a change in the size and scope of clinical trials? What does this mean for the pharmaceutical industry and the patient? “Personalised medicine” is a current buzzword, but what does it actually mean? Some say it has the potential to affect the entire landscape of our healthcare system over the next ten to 20 years. Abel Ureta-Vidal explores the potential benefits, but also the risks and challenges.

A Marriage Made in Heaven or Grounds for Divorce: ICR Project Management Forum

Sarah Muller MICR

Christopher Colombus, Kevin and Perry, men from Mars and women from Venus were all mentioned at the ICR forum on ‘A Marriage Made in Heaven or Grounds for Divorce: Exploring the interface between Project Management, Data Management and Statistics.’ This forum took the form of a debate on the motion “The data management and statistics functions are well managed by project management”. Following the formal debate, there was plenty of time for discussion between the speakers and audience. Sarah reports…

People

Exploring an Innovative CRO Business Model: An Interview

Susan Ollier HonFICR CSci & Paul Thompson

Paul Thompson is Director of Business Development and Susan Ollier HonFICR CSci is Director of UK Operations at QED Clinical Services. Many readers of CRfocus will know Susan better as Chair of ICR until she reached the end of her term at this year’s AGM, but she also ran a consultancy which recently merged with QED Clinical Services. We discuss the company’s franchise business model, the importance of cultural fit and the importance of commercial and operational innovation in the CRO sector.

Prof. development

ASM Posters: 2009 Entries & 2010 Submissions

Andrew Smith

The Institute of Clinical Research is pleased to announce that its 31st Annual Conference and Exhibition, with an overall theme of “Science, Society and Economics: Shaping the Future of Clinical Research”, will once again include a poster session. In this brief introduction to the 2010 competition, we present some highlights from the 2009 competition and invite you to submit an abstract for a poster at this year’s event. You can submit your poster abstract for consideration using the online form at www.icr-global.org/community/conferences/31st-annual-conference-exhibition/poster-abstract-submission/. The deadline for poster abstract submissions is Friday 5th February 2010.

10 Things You Need to Know About… Being Resilient at Work

Helen Chapman

Resilience is the ability to stay balanced and to bounce back quickly from setbacks and adversity. Resilient people stay committed and increase their efforts when the going gets tough. Some people are born naturally more resilient than others, but anyone can improve their resilience through effective awareness and training. This article will give you ten simple ideas for becoming more resilient to the ever-changing world around you and reassure you that a key aspect of being resilient is knowing that although you may not be able to change the environment around you, you can change how you choose to let it affect you.

Regular update

The Challenges We Face: Varied but Interlinked: Message from the Chair

Janette Benaddi MICR CSci

It is impossible for anyone to replicate the direct experience of all our members, not having worked in every sector. However, as Janette explains, she tries to understand the major issues affecting you and encourage you to become more involved yourself as opportunities arise for influencing the shape of clinical research. It is always interesting to learn that the challenges we face are often similar despite our diverse therapeutic fields and specialisations.

It’s Not All Work, Work, Work…

Compiled by Andrew Smith

Our regular look at the lighter side of clinical research, including reality TV formats to raise the profile of clinical research, pharmaceutical brand names that never made it to market and “Ten things that shouldn’t be used as project performance metrics…”.

Table of Contents: CRfocus 20(09) – September 2009

CRfocus 20(09) – September 2009

This is the Table of Contents of Clinical Research focus 20(09) issue for September 2009. Members of The Institute of Clinical Research can view the full text of each article by clicking the link and logging in with their username and password. Due to its special significance, the cover story is accessible to all, free of charge, during September 2009

Feature

Still Relevant After All These Years? Should ICH GCP be Reviewed & Revised? – FREE ACCESS DURING SEPTEMBER

Compiled by Andrew Smith

ICH guideline E6 (ICH-GCP) is, along with the Declaration of Helsinki, arguably the most important document in clinical research. Since its adoption in 1996 (in Europe; 1997 in the USA and Japan), ICH GCP has been the ‘bible’ for CRAs, auditors and other clinical research professionals worldwide. However, the world of clinical research has moved on quite some way in the past 13 years. Following a remark made by a speaker at this year’s ICR Annual Conference, we wondered whether ICH E6 should be reviewed and potentially revised. We undertook a qualitative survey, asking all CSci and FICR members what elements of the guideline should be updated and/or what should be added that did not exist in 1996. We present some of the most interesting and provocative comments.

People

A Leader of CRO Innovation & Growth: An Interview

Rob Davie PhD MICR

Dr Robert Davie is Vice President and General Manager, Europe, for Clinical Development at Covance. In this interview with Andrew Smith, he talks about the current period of innovation in outsourcing arrangements, the challenges of long-term global partnerships between CROs and pharmaceutical companies, learning lessons from other industries, differences between ‘old’ and ‘new’ Europe and the ‘flattening’ of the world of developing medicines.

Where Have All the Career CRAs Gone? An Interview

Stewart Hulse

Stewart Hulse is Director of Recruitment Services for Novella Clinical. In this brief interview with Max Golby, he discusses what has happened to the once-great well of monitoring expertise, and what has led new CRAs to chase the ladder of promotion as fast as employers will allow. He calls for better rewards for long-term CRAs to retain that expertise and points out that going freelance too early can actually be a career-limiting move.

National updates

Changes Across the Pond: Barack Obama, Stem Cells, Incentives & Pre-emption

Angus E Donald LLM HonFICR

In the latest in a series of letters from his new home in the USA, long-time ICR member Angus Donald reports on some of the significant changes around clinical research and healthcare in general that are taking shape in the first few months of the presidency of Barack Obama. The past few months have seen considerable changes in the landscape of pharmaceutical development in the US and indications suggest that these radical changes, both in administrative policy and litigation, will continue during the current administration. Angus discusses the changes in funding for basic medical research, including human embryonic stem cells, financial incentives for innovation, an expanded budget for the FDA, and closing loopholes on ‘exclusion payments’ on generics. He also goes into detail on the issue of pre-emption, and discusses the implications of the recent US Supreme Court ruling on Wyeth v Levine.

Net Benefits of Working with Networks? The ICR Scottish Forum

Graeme Scott HonFICR CSci

The ICR Scottish Forum is now in its ninth year and it is clear from attendance figures that it continues to offer what ICR members want. A healthy 70 or so of us attended the forum’s February meeting to listen to Dr Clare Morgan, Dr Matthew Cooper and Dr Roma Armstrong tell us about the progress and performance of the Research Networks both North and South of the border. There was the usual opportunity for awkward questions and healthy debate. Graeme Scott presents this report, which is equally relevant for those of us working outside Scotland.

Prof. development

Trials & Tribulations of Monitoring: A Week in the Life of a CRA

Polan Chetty & the ICR CRA Special Interest Group

When Polan Chetty and her colleagues in the ICR CRA Special Interest Group started writing this article, they tried to describe a typical week in the life of a Clinical Research Associate. However, any CRA will tell you that there is no such thing as a typical week. If you are hoping for a straight 9 to 5 job, you are not going to find it here. While the few days described are fictional, they are entirely realistic…

Viewpoint

OLS Blueprint: PICTf 3.0?

Andrew Smith

The counter-balance to increasing constraints on NHS spending on pharmaceuticals comes in the form of various initiatives to make more of a contribution in terms of investment by the UK government in education and training, infrastructure and organisational processes. The latest of these is the Office of Life Sciences (OLS) Blueprint, which was published over the summer. The Blueprint sets out 12 key action points, expanded to 10 pages of specific policy measures, complete with timelines and budgets, of which the policy that will be of most interest to us is the “package of measures to improve the UK environment for clinical trials”. The Blueprint has been widely welcomed by industry and commentators alike. Andrew offers “two cheers” but also sounds a note of scepticism…

Regular updates

It’s All About You: Our Members! Message from the Chair

Janette Benaddi MICR Csci

This month, as many of us return from our summer vacations, Janette Benaddi shares more information on the demographics of the entire ICR membership. If you have had the opportunity to attend our Annual Conference you will have experienced at first hand the diversity of our members and will have perhaps been astounded by the different fields our members work in. As an Institute for professionals it is important we try our best to cater for all our members whether minority or majority. You may think that with such diversity in roles and affiliations this might be difficult. However, what is interesting to one group of members will often be interesting to others. We have recently adjusted the membership prices to more closely reflect the costs to serve our members and help to bring us more in line with other professional bodies. We are looking at new ways of serving the specialist groups and are constantly striving to improve our service offerings.

It’s Not All Work, Work, Work…

Compiled by Andrew Smith

Our regular look at the lighter side of clinical research, including some unlikely holiday destinations for clinical research professionals, some possible side effects we might not need to be quite so worried about, and “Ten news stories that weren’t covered by the world’s clinical research media”.

OLS Blueprint: PICTf 3.0?

The UK pharmaceutical industry is one of the most significant industries to make money for ‘UK plc’ and re-invest it back into UK-based R&D, within their own organisations, in universities and throughout the NHS. As many have said, the UK ‘punches above its weight’ in our sector. Despite this, we often feel unloved, in terms of both media and public opinion and increasing constraints on revenue (eg, prescribing decisions being led by NICE guidance while reimbursement rates have been cut under the successor to the PPRS). However, the counter-balance to this top-line constraint has come in the form of various initiatives to make more of a contribution in terms of investment in education and training, infrastructure and organisational processes. As a globalised industry has far less binding ties to doing its R&D in the UK than it did 30 years ago, this policy makes a great deal of sense. Over the past decade or so, these initiatives have come under the banners of PICTf, UKCRC and, now, the Office of Life Sciences (OLS) Blueprint, which was published over the summer.

The Blueprint set out 12 key action points, which have been agreed across government, industry, the higher education sector and the NHS. This expands to 10 pages of specific policy measures, complete with timelines and budgets. The Blueprint has been widely welcomed by industry and commentators alike, and certainly, every policy measure should have a positive effect.

The measure that has received the most coverage is the Innovation Pass, ring-fenced funding for time-limited use across the NHS without appraisal by NICE (although NICE will define the criteria for medicines that can take this short-cut). This will be piloted in 2010/11 with a budget of £25m. While initially portrayed by the media as bypassing NICE, this could be a valuable experiment in ‘live appraisal’ mirroring the ‘live licensing’ model proposed by PricewaterhouseCoopers in their Pharma 2020 reports.

The policy that will be of most interest to us in the clinical research sector is the “package of measures to improve the UK environment for clinical trials”. This includes ensuring the UK “fully exploits its potential to be a world leader in heath informatics” (ie, making electronic patient records finally happen!), underlining the duty for SHAs to promote R&D, adding metrics on patient in clinical trials to Trusts’ Quality Accounts, and creating a national framework for local management of research (ie, transforming NHS R&D departments). Significantly, the last three points are essentially reworking areas covered by PICTf nearly a decade ago…

The questions that need to be asked about all these measures, though, are “Will they be implemented as planned?”, “Will they result in improvements in the productivity of UK R&D and uptake of resulting products?” and “Are they sufficiently different from previous initiatives to justify the top-line reduction in reimbursement for medicines?” The many intelligent and powerful people close to this project evidently think so. Far be it from me to disagree, but the fact that this is the third major initiative in less than a decade suggests that its predecessors did not maintain momentum in their improvements (or, more cynically, that pharma are getting increasingly itchy feet in the light of increasing competitiveness overseas).

To sound another small note of scepticism, the UK is less than 12 months from a general election, with a change of government far more possible than at any time since 1997. Although many measures in the Blueprint can be implemented almost immediately, many will take time to demonstrate success, and none will be immune from reversal under a new government.

So, I would like to raise two cheers for the OLS Blueprint: it talks a good game and will certainly have some success, but will it be enough to steady ship of UK competitiveness or just the latest in a series of defences against an insuperable drift to merely “punching our weight”? We will see…

End of term reports?

You can tell it’s summer! In the latter part of July, large parts of the clinical research establishment evidently winds down for a summer recess. In the past few days, three substantial and (to a greater or lesser extent) significant reports have thudded onto my desk (metaphorically, of course – I read them as PDFs…)

• Life Sciences Blueprint – A Statement from the Office for Life Sciences (July 14th)
• The Case for Globalisation: Ethical and Business Considerations in Clinical Research (July 21st)
• Appraising the Value of Innovation and Other Benefits: A Short Study for NICE (July 22nd)

I would like to be able to give a detailed analysis of each of these documents, discussing which of their many recommendations seem to be the most feasible and/or helpful. However, arriving so close together (and as we’re getting the August issue of CRfocus to print) I have only had time to skim them so far, so the best I can do is suggest that you take a look at them yourself.

As one early aside, it might be worth considering the OLS Blueprint (an action plan to re-energise and optimise the UK’s innovative pharmaceutical industry) in the context of PICTf, which was a series of reports, workstreams and metrics that ran in the first half of this decade. Much of what has made UK clinical research what it is today had its source in the PICTf work programmes, so it remains to be seen how much of the Blueprint builds on those developments, and how much re-addresses topics that PICTf initiatives didn’t quite manage to resolve. Also, with a UK General Election less than a year away, and a change of government certainly not beyond the realms of possibility, it might be interesting to wonder how many of the report’s 12 key action points would withstand a shift from Labour to Conservative.

Perhaps more likely to maintain its relevance should the Conservatives win power next year is the report by Professor Sir Iain Kennedy’s report on how NICE might better handle the valuing of innovation in its analysis of the economic impact of new health technologies. Although it sticks with the basic ICER/QALY framework, it makes some strong recommendations on what further research is needed and on a pilot scheme for  innovation might be rewarded. This chimes with the “Innovation Pass” idea in the OLS Blueprint, which was initially portrayed in the media as something of a snub to NICE, but is perhaps more an anomoly of publication timings.

If these two reports are quite UK-specific, the middle one is definitely global in scope. Commissioned by the ACRO (the US trade body for CROs, representing the head offices of many of the world’s major contract research organisations) the report aims to demonstrate that clinical research in the “pharmerging” countries is of a comparable standard of safety and ethics of the traditional countries (ie, USA, western Europe etc.) and speed, scale and reduced cost present a compelling case for embracing the shift of larger clinical trials to these new regions rather than railing against it. From my initial reading of the report, this seems something of a tautology: because the studies are commissioned by western sponsors, often conducted by local affiliates of western CROs and designed to collect data to support western registration with the FDA, EMEA etc. is it really surprising that the standards achieved are broadly similar. Still, it’s important for the rest of society to recognise this if they hadn’t already (much of our industry realised this some years ago).

For all three reports, there is then the question of momentum. By the time the world starts getting back to speed in September, we might have had time to ponder some of their more complex recommendations, but others might have forgotten about them entirely! So, let’s make the effort and read them now…

EFGCP workshop on a single clinical trial application for pan-national studies

I’ve just worked out how long it’s been since I posted something here that hadn’t already been published elsewhere (ie, reportage or fresh comment rather than the Table of Contents of the current issue of Clinical Research focus). Things have been a bit manic here in the CRfocus office, with CRfocus and other ICR tasks (mostly related to our website and our 2010 conference) taking priority over blog-only posts. Hopefully, as the summer holiday season gets into full swing, I’ll be able to blog a bit more…

Ironically, today’s the day when I really would have preferred to reporting from Brussels on the EFGCP’s latest workshop, building on the ICREL workshop in December 2008 to discuss possible routes towards a single clinical trial application for multinational clinical studies. This could be of huge benefit to the efficiency of setting up large-scale clinical trials in Europe, and some of the contenders (eg, the “Voluntary Harmonisation Procedure” currently being piloted by the Clinical Trials Facilitation Group (CTFG) of the Heads of Medical Agencies) are very exciting indeed.

Unfortunately, my schedule is such that I couldn’t make it there without some incredibly long-winded travel plans that would have doubtless resulted in substandard reporting anyway…

I’m very supportive of this event, and this project overall. While I’m not able to report on it first-hand, I’m hoping to publish a brief report from someone else who is there today, and possibly arrange an interview or two with key participants over the coming weeks. This is too important a project not to do everything we can to engage everyone in the process.

CRfocus: Table of Contents of July 2009 issue – 20(7)

CRfocus 20(07) – July 2009

This is the Table of Contents of Clinical Research focus 20(07) for July 200. Members of ICR can click the links below and log-in to read the full text of these articles

Outsourcing

The Evolution of Outsourcing: Contract Management Coming of Age

Andy Parrett

The contract management role in clinical development outsourcing is still a relatively young profession. The nature of the role can vary significantly between pharmaceutical companies. Andy Parrett, Chair of the Pharmaceutical Contract Management Group (PCMG) suggests that the most exciting developments in the role are occurring in today’s small to mid-sized companies, and looks at how the processes surrounding outsourcing and its successful management are being developed.

Features

EudraCT Upgrades to Version 7

Andrew Smith

An information day was held by the EMEA at the end of April, bringing together representatives of national Competent Authorities (CAs), pharma companies, CROs and non-profit stakeholder groups. The purpose of the day was to communicate the features and development timelines of the next few versions of the EudraCT database of clinical trials in the European Economic Area (EEA), which went live in mid-June. Andrew reports, based on blog postings made on the day of the meeting.

CDISC European Interchange 2009: Conference Sketch

Adam Jacobs FICR CSci

CDISC (the Clinical Data Interchange Standards Consortium) is a relatively new player in the world of clinical research, having been founded in 1997, but it is rapidly gaining in importance, and is here to stay. To keep up with some of the latest developments in the CDISC world, Adam reports from the European CDISC Interchange, held in Budapest in April 2009.

Quality Assurance: Friend or Foe? A Survey

Jan Robinson MICR CSci

No-one questions the need for quality assurance of clinical trial activities but as someone at the receiving end have you ever been asked your opinion of the process? In your view, is audit a positive force for improvement? Are they the best means of advancing best practice or should we be taking a different approach? Jan invites you to take part in a short survey, to be reported in CRfocus and at the BARQA annual conference later this year.

Writing Protocols: Collaboration & Compromise or Conflict & Confusion? ICR/EMWA Joint Symposium

Alex Dedman & Andrew Smith

The challenges of developing clinical trial protocols were the topic of the second annual symposium jointly hosted by the European Medical Writers’ Association (EMWA) and The Institute of Clinical Research (ICR) on 24 February 2009. Around 60 delegates discussed the difficulties associated with developing protocols that both meet sponsors’ scientific and regulatory requirements, and facilitate the practical conduct of the study. Alex and Andrew report for CRfocus and The Write Stuff, the EMWA members’ journal.

People

Why You Should Care About the Innovative Medicines Initiative: An Interview with Jackie Hunter

Edward Blair MICR

The EU Innovative Medicines Initiative (IMI) was established in 2007 and issued its first call for proposals in 2008. Funding for the successful proposal has been allocated and the work kicks off in June this year. So, the IMI is for real and is beginning to deliver, but how well known is it and why will it change the pharmaceuticals industry in ways that will benefit ICR members? To get a first-hand insight into the aspirations of the IMI, CRfocus talked to Dr Jackie Hunter of GlaxoSmithKline, who has seen the IMI develop from a twinkle in the eye of EFPIA into the operating entity that it is now.

Conference

We are pleased to include two more session reports from the ICR Annual Conference, which space prevented us from including in last month’s issue.

International inspections

Fergus Sweeney & Gunnar Danielsson

Reporter: Judit Varkonyi-Sepp MICR CSci

Organ Transplantation: Past, Present & Future

Prof. James Neuberger & Mr Simon Bramhall

Reporter: Ali Zataar MICR CSci

Regular update

The Board of Directors: Who Are They & What Do They Do?: Message from the Chair

Janette Benaddi MICR Csci

The Institute of Clinical Research has a legal status of “a company limited by guarantee” and this means that it has to be managed by a Board of Directors. As members, you may wonder from time to time what the ICR Board of Directors do, who they are and how they add value to ICR members. Janette answers these questions, explains how the Board operates, and confesses her early (now-achieved) professional ambition to be a Board Director herself.

CRfocus: Table of Contents of June 2009 issue

CRfocus 20(06) – June 2009

This is the Table of Contents of Clinical Research focus 20(06) for June 2009. Members of The Institute of Clinical Research can click on the links to read the full text of each article.In previous years, we have endeavoured to publish reports on all conference sessions in this issue. However, due to constraints on page space and available reporters, we have decided to publish a balanced selection of reports in print, with others (and extended versions of printed reports) becoming available here during June.

Conference photo-gallery

Photos uploaded during the meeting, plus many additional images

Plenary sessions

Lively Debates & Votes:Day One Plenary Sessions

• Niall Dickson, Prof. Karol Sikora, Prof. Nick Bosanquet, Francis Crawley & Colin Miller FICR CSci
• Reporter: Suheila Abdul-Karrim MICR Csci

Pharma 2020: VirtualR&D

• Kate Moss
• Reporter: Andrew Smith

Lively Debates & Votes: Day Two Plenary Sessions [online only, coming soon]

Sharing knowledge

Off-Shoring in ClinicalResearch [extended version, online only]

• Prof. David Jefferys & Paul Wathall MICR
• Reporter: Wendy Tomlinson MICR

Stem Cells: Current Advances & Applications

• Prof. Peter Andrews & Prof. Malcolm Alison
• Reporter: Jane Pelly MICR Csci

Contracts in Global ClinicalTrials

• Rebecca Sergeant & Sarah Watts
• Reporter: Judit Varkonyi-Sepp MICR Csci

Electronic Data Capture (EDC): Issues & Practical Solutions [online only, coming soon]

The A-Z of Adaptive Study Design [online only, coming soon]

Fundamentals of PIPs [online only, coming soon]

Therapeutics

Oncology Care in the Future [extended version, online only]

• Prof. Angus Dalgleish, Prof. Nicholas James, Prof. Jonathan Waxman & Prof. Will Steward
• Reporter: Shethah Morgan MICR Csci

The Heart of Cardiology

• Dr Mike Mullen & Dr Marcus Flather
• Reporter: Sue Jackson RICR

The Heart of Cardiology [extended version, online only coming soon]

Organ Transplantation: Past, present & future [online only, coming soon]

Raising standards

The Impact of theDeclaration of Helsinki

• Eva Nilsson Bagenholm MD & Bev Holt MD
• Reporter: Rachael Winter RICR

Quality & Productivity:Can You Have Both?

• Alison Messom MICR & Andrew Borrisow
• Reporter: Wendy Tomlinson MICR

Evidence for Good Quality:The Hidden Cost of Inspection

• Prof. Richard Gray & Joan Perou HonFICR
• Reporter: Suheila Abdul-Karrim MICR Csci

International Inspections [online only]

• Fergus Sweeney & Gunnar Danielsson
• Reporter: Judit Varkonyi-Sepp MICR CSci

Putting a Price on Patient Value [online only, coming soon]

Inspectors: Why Do They Do It? [online only, coming soon]

Developing professionals

Medical Devices Workshop [online only, coming soon]

Image in Business: It’s Personal [online only, coming soon]

Project Management Workshop [online only, coming soon]

Leadership Workshop [online only, coming soon]

Regular updates

Session Reports from theICR Annual Conference: Message from the Chair

• Janette Benaddi MICR Csci