Table of Contents for CRfocus 21(07) – October 2010

This is the Table of Contents of Clinical Research focus 21(07) for October 2010.

This issue will be published in the next few days. At that time, ICR members will be able to download the entire issue [login required] using our eCRfocus service.

Features

Process Maps, SOPs & the Quality System: The art of writing friendly, user-effective SOPs

Janice Hedgecock FICR CSci

It is important that Standard Operating Procedures (SOPs) are user-friendly and provide the information people need to carry out their daily activities. Janice reports from this conference, which programme covered a wide range of topics, from the regulatory background to SOPs, through the SOP lifecycle, to training on SOPs and auditing them. David Kill HonFICR, who chaired the event, noted that many people have a love-hate relationship with SOPs: they don’t like having to follow them, but object when they are changed. Janice tells us more about how to write friendly, usable, effective SOPs

“From a regard to truth”: James Lind & the Implementation of Research Findings

Allan Gaw & Michael H J Burns

This article is the first in a series looking at key individuals in the history of clinical research and demonstrating that we can still learn from their achievements today. When patients agree to take part in clinical trials there is a contract, albeit implicit, that their involvement and their sacrifice will be rewarded by consequent improvements in medical practice, built upon the findings of the study. The implementation of research findings into clinical practice is, however, not a simple task and is one which has many obstacles and barriers to its completion. This is true today, but was also true more than 250 years ago and is exemplified by the story of the Scottish Naval Surgeon, James Lind.

People

The MHRA Phase I Accreditation Scheme: An Interview with Gail Francis & Rebecca Harrison

Interviewed by Harriet Wibberley MICR

In 2007, the Medicines and Healthcare products Regulatory Agency (MHRA) published details of a proposed voluntary accreditation scheme for Phase I units for public consultation, as a direct result of the recommendations made following the TGN 1412 incident in 2006, in which clinical trial subjects became seriously ill. This accreditation scheme has since been rolled out and 15 units were awarded accreditation between April 2008 and July 2009. The scheme has been a huge undertaking, not just for units applying, but also for the MHRA itself. This interview was conducted in March 2010 with Gail Francis and Rebecca Harrison from the MHRA, as part of the ICR Clinical Pharmacology Advisory Group’s review of the scheme and its implementation.

Professional development

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

Helen Chapman

Effectiveness is the ability to get the right things done with the minimum effort and maximum fun! Most of us know the principles of effectiveness and how we can perform when we are at our best. However, in our hectic business lives it is very easy to mistake ‘busyness’ for ‘effectiveness’ and if we are not careful we can work really, really hard achieving nothing of real value. In this article, Helen offers ten simple ideas for becoming more effective at work. If things are hard for you at work at the moment, why not take half an hour ‘out’ right now and explore how you might overcome some of your current issues and challenges and get your ideas and actions to flow.

Investing in Leaders for the Future: ICR/Cranfield Research Training Fellowships

Paul Wathall MICR

For over 30 years the Institute has contributed to the creation of a healthier future by supporting research training of the highest possible standards. To supplement our training and networking opportunities for members, together with Cranfield University, we are launching a prestigious new Research Training Fellowship competition, the results of which will be announced at next year’s Annual Conference. ICR’s Interim Chief Executive Officer, Paul Wathall, explains how this new programme will work.

Table of Contents for CRfocus 21(5) – June 2010

This is the Table of Contents of Clinical Research focus 21(05) for June 2010.

ICR members can download this entire issue [login required] using our new eCRfocus service.

Features

Latest Fashion or Emperor’s New Clothes? Technologies in Clinical Project Management

Tanya Palmer MICR & Jan Robinson MICR CSci

Tanya and Jan report on a meeting of the ICR Project Management forum, which took a look at some of the technologies now being employed within the industry. Is there any evidence that they really accelerate timelines, increase quality and make us more effective? Alternatively, has the well-intended introduction of new technologies created a monster that saps resource, slows us down and generally has a negative impact on our performance? Workshop sessions also discussed, given that we have all this technology at our disposal, how do we decide what to implement in our organisations, and what is appropriate for any given study scenario?

Do Clinical Trials Have a Future in the UK? ICR Resourcing Forum Debate

Joanna Nelley RICR

Joanna Nelley provides a preview of a “Great Debate” planned by the ICR Resourcing Special Interest Group for the Autumn, with senior panellists from industry and the NHS discussing the future position of the UK in the global clinical trials marketplace.

Book review

“Breast Beating” by Prof. Michael Baum FRCS

Reviewed by Andrew Smith

This touching book, subtitled “A personal odyssey in the quest for an understanding of breast cancer, the meaning of life and other easy questions”, enriches as much as it educates and entertains. Following the conventional framework of a memoir by someone nearing the end of a glittering professional career, Michael Baum also gives us a tour of the history of breast cancer and its treatment, recounting many of the key moments in the past 40 years with a first-hand perspective.

Viewpoint

Following an Example… & Setting One

Andrew Smith

We are in a period of preparing for change. In the face of increased global competition, particularly from countries where clinical research was simply not conducted a decade ago, we are acknowledging at a UK and a European level that “something must be done”. But, while the wheels of political and regulatory change grind slowly onwards, what do the rest of us do for now? In the meantime, we should all look at the example being set for us by the CTFG VHP, the NW Exemplar and other initiatives, inject some more energy and passion into our work, and actively set an example for our colleagues to follow.

ICR update

A Strategy for Development

Paul Wathall MICR

Paul Wathall, currently serving as Interim Chief Executive of the Institute, reflects on the tribulations of the past 18 months, and the need to set a new strategy to move ICR forward into a future even brighter than its past. He provides some pointers to elements that will be included in this strategy, and calls for all members to engage more with ICR, to help us help you better, with feedback on what we can do to serve your professional needs as our industry enters a new era of promise and exciting opportunities.

It’s Not All Work, Work, Work…

Andrew Smith

We take our regular look at the lighter side of clinical research, including “Ten examples of delegate feedback to GCP training” and the inevitable string of jokes about clinical research and the World Cup.

Science, Society & Economics: Shaping the Future of Clinical Research: ICR 31st Anniversary Conference & Exhibition

It’s that time of year again: here at the ICR office, we are making the final preparations for our Annual Conference, which is just a few weeks away on April 19^th and 20^th. The conference is ICR’s flagship event, and a high point of the year for clinical research professionals. Delegates, speakers and exhibitors come to learn about and discuss the issues facing professionals in their work designing, managing and conducting clinical trials.

The past couple of years have been challenging for us all, in terms of time and budget to invest in our professional development and networking. We’ve listened to your feedback about previous ICR conferences, and have built on the changes we introduced last year to give you the best event possible, with a programme of relevant and informative sessions for all the diverse roles making up the ICR membership. The 2010 ICR conference makes it easier for you to reconnect with your profession, and create new opportunities for yourself and your company.

After several years in the centre of England, we are bringing the conference to London for the first time in its history. This recognises the fact that more than half our members live within a couple of hours of the city. The Hilton Metropole, a few minutes away from Paddington station, is within easy reach of national and international transport services, whether you’re coming by car, train or plane.

For the first time in nearly a decade, the conference will be held in the hotel where most of the delegates, speakers etc. are also staying. This meant that we were able to offer delegates who booked their places early preferential rates on their hotel reservations. You also have the benefit of being able to carry on discussing issues after the conference formally closes, at our networking drinks reception on the Monday evening, in the bar or over dinner, or even over a shared breakfast before the second day of the conference opens.

Another important change is that we’ve frozen delegate prices to remain at their 2009 levels, to help members in these challenging economic times. This makes the ICR conference even better value for money than other multi-stream conferences.

If you can only go to one conference…

This year, we have a varied selection of relevant, knowledgeable and experienced speakers to discuss the important issues facing us all. All of the topics to be discussed at this year’s conference will impact on the way you work now and in the future, either directly on indirectly. Whatever your role in clinical development, and whatever point you’re at in your career, it’s vital that you stay up-to-date with the latest developments and make your voice heard in the discussions about their implementation, impact and implications.

The overarching theme of the conference is that clinical research is influenced by both internal and external factors, with economics and politics often having as great an impact on the way we work to develop new treatments as developments in medical science and operating procedures. The interfaces between these areas will provide the clinical research community with its greatest challenges, and its greatest opportunities, over the coming years.

Plenary sessions: Personalised healthcare & Health economics

Plenary sessions on key topics will close each day’s proceedings.

In the first of these, speakers from AstraZeneca and Roche will look at personalised healthcare, certainly an indicator for the way many future medicines will be developed and studied. The technological, scientific and clinical advancements in pharmaceuticals R&D over the past decade has ensured that the concept of personalised healthcare is now rapidly becoming the practice of personalised healthcare, particularly in infectious disease and oncology. This important field has implications reaching into patient recruitment and informed consent, pricing and economics, biomarkers and companion diagnostics etc.

The second plenary session will close the conference with a detailed look at the economic evaluation of healthcare technologies, which is increasingly used to inform social choices about access to innovative treatments. This is a field where the UK leads much of global thinking. Professors Richard Lilford and Karl Claxton, both of whom are close to the development of these ideas and their practical application, will discuss which health technologies should be approved or covered for use, what price ought to be paid for such technologies and how much and what type of evidence is required to support coverage or approval. The changing health-economic landscape will have an increasing impact on which clinical development programmes take priority, how individual clinical trials are structured, and how additional kinds of information need to be collected and analysed.

Parallel sessions: From patient recruitment to research governance

There are too many exciting topics being covered in the 12 parallel sessions to discuss them all in detail, but here is a selection of sessions that are proving popular with early-registering delegates:

Dr Clare Morgan of the NIHR Clinical Research Network Coordinating Centre will review what the NIHR CRN is doing to improve reliability, including improving confidence around quality study feasibility assessment, access to a wider pool of committed investigators with dedicated, trained resource to support study delivery and proactive study performance management.

Gaynor Anders and Prof. Theo Raynor urge us to “think outside the box” about patient recruitment. Real progress is being made on several fronts of the challenge to meet the study participation needs of research programs. However, there is still a huge gap between those needs and the collective willingness and ability of patients to enrol in studies.

Mark Lewis MICR and Christine McGrath MICR will explore the challenges and tactics involved in applying policy-level initiatives in practice at individual Trusts, to enhance and streamline UK clinical research. They will also discuss how to improve the performance of individual R&D departments (in terms of quality, speed, added value etc.).

Another key update will come from Janet Wisely of NRES, who will discuss the latest developments in ethics review. She will look at the ongoing development of the IRAS application system, the 2009 pilot scheme in proportionate review, and the use of ethics advisers to help committees work more effectively by ensuring that proposals are well presented, with scientific referees’ reports if necessary.

Other sessions consider practical issues, such as the role of research nurses in the informed consent process, the changing clinical data requirements for medical devices, managing remote teams and the move towards risk-based inspections.

Full abstracts and speaker profiles for all conference sessions are available at www.icr-global.org/community/conferences/31st-annual-conference-exhibition.

Annual General Meeting: May 19^th

The ICR Annual General Meeting has traditionally been an important part of the Annual Conference. However, as announced last month and clarified elsewhere in this issue, we have decided that this year’s AGM deserves more time and attention than it can easily be given alongside the conference. Instead, the AGM will be held at the ICR office in Bourne End, on May 19^th, starting at 5pm. Further details will be published to members in due course.

More targeted exhibition

In addition to attending conference sessions and networking with your peers throughout the industry, many delegates also come to the conference to find out more about potential new suppliers, and the exhibition has always been an important addition to the ICR conference. This year’s exhibition is already sold out, and we are pleased to have the support of so many companies from throughout the clinical research sector.

However, after listening to your feedback over previous years about the balance of exhibiting companies and the sometimes overly intrusive attitudes of a few individual stand personnel, we have decided to reduce the size of the overall exhibition, and particularly the proportion of recruitment agencies that have been invited to exhibit. Along with our Exhibitors’ Code of Conduct, this means that you will be able to walk through the exhibition aisles without concerns, and decide without pressure which companies you’d like to talk to.

Make the most of your membership

As I write this piece, in March, many of you have already registered to attend the conference, and it is becoming obvious that several of the sessions will be well attended. If you are struggling to find the time (or the budget) to come to the full meeting, we are offering single-day conference passes at reduced rates.

As we hope you’ll agree, this year’s Annual Conference will have something for everyone: plenty to learn, plenty of business benefit, but also plenty for us all to enjoy. We are also offering special reduced rates for professionals working in academia or the public sector, and to full-time students. To reserve your place, simply fax back the form on the back of the conference flyer enclosed with this issue of CRfocus, or register online via the ICR website (www.icr-global.org/community).

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.

Table of contents: CRfocus 20(12) – December 2009

This is the Table of Contents of Clinical Research focus 20(12) issue for December 2009. Members of ICR can click the links below and log in to read the full articles.

Future of Clinical Research

High Aspirations & Mixed Expectations: Assessing the Future of Clinical Research

Compiled by Andrew Smith

A regular feature of the end of the year in Clinical Research focus is our ‘crystal ball’ article, in which ‘movers and shakers’ and other key observers look into the future to tell us what they expect, or hope, to see changing over the coming years.

2009 in review

Some ICR Highlights of 2009: Message from the Chair

Janette Benaddi MICR CSci

Janette looks back at what ICR has done over the past 12 months and talk about some of the highlights of this year. Although it has been a difficult year for ICR, with the recession impacting some areas of our organisation, there have been many highlights and I feel as we go into a new year it is these successes that we should be celebrating.

Clinical Research Highlights of 2009

Andrew Smith

Most of us are slogging through to the end of 2009, battered and bruised by the economic turbulence, the accelerating strategic shift in where clinical research is being conducted and, more insidiously, the feeling of uncertainty that all of us are feeling as a result of these factors. Still, it is also important to recognise that there have been some positive developments in the sector, some of which will continue to have an impact long after this recession is gone and forgotten.

2009 Article Index

We present our regular index of all articles published in CRfocus during 2009. Nearly 100 articles have covered a wide variety of topics throughout this year. Under difficult trading conditions, we have taken the opportunity to increase the proportion of editorial pages by around 10% so as a reader you are getting more concentrated value from your ICR membership. Don’t forget, one of the many benefits of ICR membership is that you also have full access to our online archive, containing almost every article published in CRfocus since 2001, now amounting to well over 700 articles. We also present our editorial themes for 2010, from Offshoring and Early phase to Governance of research and the potential for “EU Directive 2.0”.

Features

To File or Not to File… & Other Questions: ICR Freelance Forum

Danielle Jacobs

A clinical research freelancer’s life can be a bit solitary at times, so the annual ICR Freelance Forum provides a much-appreciated opportunity for freelancers to socialise and network with colleagues, and to learn from each other and from invited speakers. This year’s forum took place on November 3rd at the ICR headquarters in Bourne End. Topics reported by Danielle include records management, MHRA inspection of freelancers, surrogate biomarkers and the impact of clinical research networks.

GCP Discussion: Pregnancy of Research Subject’s Partner

Nicky Dodsworth MICR CSci & the ICR GCP Forum Steering Group

Questions submitted to the ICR GCP Forum are sometimes discussed by the Steering Group between meetings, and in the case of this query, relating to the informed consent and safety reporting issues raised by the partner of a clinical trial subject becoming pregnant, the team thought that it would be beneficial to share their thoughts with readers of CRfocus rather than wait until the next Forum meeting.

Don’t Panic, It’s Not All That Bad! Employee Confidence Survey

Catherine Gutsell

Following a recent comparison survey conducted by CK Clinical, which researched the attitudes of jobseekers in the pharmaceutical industry in January compared to that of July 2009, it seems respondents generally feel the wider economy is on the mend. However, at grassroots level, employees in the pharmaceutical industry are starting to feel the bite of the recession. Catherine Gutsell interprets the results of the survey.

People

A British Medic in Global Big Pharma: An Interview with David Gillen

Interviewed by Andrew Smith

David Gillen is Head of Medical for the Pfizer Primary Care Business Unit covering Europe, Canada, Australia and New Zealand. Until last year, he was UK Medical Director. He is a member of the Editorial Advisory Board of the British Medical Journal and also serves on sub-committees of the ABPI, NICE and UKCRC. We discuss health technology assessment, the role of medics in the pharmaceutical industry and how the UK should look to specialise and become more entrepreneurial. An audio version of the complete interview, including additional material not covered in this transcription, is available from the CRfocus website (www.crfocus.org).

Prof. development

Launch of the ICR Clinical Trial Administrator Manual: Written for CTAs by CTAs

Rebecca Garland & Judi Eaton

The Clinical Trial Administrator Special Interest Group (CTA SIG) is proud to announce the launch of a CTA Manual, written for CTAs by CTAs, to serve as a centralised reference document for CTAs throughout the industry. This document contains essential background information, covering topics such as the structure of a typical clinical department, industry-related acronyms, some of the key roles and responsibilities of a CTA and a snapshot of relevant areas of clinical research and its processes.

Regular update

It’s Not All Work, Work, Work…

Compiled by Andrew Smith

We take a festive look at the lighter side of clinical research, including Christmas carols adapted for use by clinical research professionals and “Ten things we wouldn’t want to receive from Secret Santa at the departmental Christmas Party”.

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 http://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…”.

Cartoon from November’s CRfocus – 20(11)

Catherine's study team had changed so many times, she'd done more staff inductions than site initiations.

Table of Contents: CRfocus 20(10) – October 2009

This is the Table of Contents of Clinical Research focus 20(10) issue for October 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.

Global competition

Multinational Trials: A New Balance Point?

Andrew Smith

Given that multinational (often ‘massively multinational’) trials are now the default position for anything beyond the earliest phase of clinical research, it is somewhat surprising that they still polarise opinion. To some, they are the only way to complete large studies even remotely on deadline and within budget. To others they are damaging to local professionals and research infrastructure and of limited clinical relevance to a medicine’s target patient population. In this extended editorial, Andrew Smith takes a look at the evolving bigger picture of globalising clinical research and suggests how we might find a new balance point to deliver global performance combined with local relevance.

Managing Clinical Research in the UK: Survey & Conference

Andrew Smith

There are many layers of perception and received opinion characterising the UK’s performance, with a basic view that we are not performing as well as we might in comparison to other countries (generally in terms of being slower and/or more expensive) and are losing business as a consequence. However, much of the evidence for this is anecdotal, and where metrics do exist they are often specific to an organisation, therapeutic area or part of the process (eg, final protocol to first patient visit). A one-day conference was held in September to discuss initial results of a 2-year study that looked across the entire research process, encompassing both commercial and non-commercial research in all therapeutic areas. Andrew reports…

Feature

My Clinical Study is Over; What Happens to the Data? An Introduction to the Clinical Study Report

Emily Scott

Conducting a clinical study takes a considerable amount of planning, resource, and commitment. But, after the last subject is out, the database has been cleaned, and the planned analyses have been done, what happens to the data that were collected? For interventional studies conducted in accordance with the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), data collected in a clinical study should be submitted to the authorities in a Clinical Study Report (CSR). Emily Scott provides an introduction to CSRs, how they should be constructed and how other study personnel should be involved.

Prof. development

Study Management for Research Nurses: ICR Research Nurse Forum

Nicky Perry MICR

The ICR Research Nurse Special Interest Group (SIG) held their second forum on June 18th at the ICR office. Sixty research nurses attended. The agenda for the day was set following the training needs analysis conducted via questionnaire, which was sent out last year. The result of this survey highlighted that nurses wanted to know more about study management, especially how to cost a clinical study.

Virtual Learning in the Real World: ICR Tainers’ Forum

Iain Searle MICR CSci, Merryn Collard RICR & Jane Nathan RICR

ICR’s Trainers’ Forum generally holds three meetings each year, designed to address topical issues and challenges for those involved in training functions across health, pharmaceutical and life science industries and services. This event was prompted by the rapid development of remote delivery methods within our sector, with a wide range of solutions being implemented across the industry. The days’ agenda had been developed by the Steering Committee, which has a mission to support the interests and further development of trainers within ICR by providing topical meetings, with expert speakers from within and beyond the pharmaceutical industry.

Trial technology

Ten Things You Need to Know About Infusion Pumps for IV Delivery in Clinical Trials

Elena Skryabina

In the latest in our series of introductions to key topics, Elena Skryabina examines the use of infusion pumps for intravenous drug delivery in clinical trials. She demonstrates the amount of control that is possible in a single Phase I unit but also the care that should be taken in larger studies, where differing pumps at different sites can impact on the precision of study drug delivery.

Book review

“Trial by Fire: Lessons from the History of Clinical Trials”

Allan Gaw, reviewed by Andrew Smith

The rationale for this excellent little book is summed up by Mark Twain, quoted in the introduction: “The past does not repeat itself, but it rhymes.” Learning about the history of clinical trials helps us to understand why the present is the way it is, and this book provides insights into ways of thinking and working that many of us would otherwise simply take as given. It is written in a clear, readable style, with interpretation as well as factual account, highlighting the aspects of each topic that have had the most significant impact on the way clinical research is done today.

Regular update

Fit For the Future: Message from the Chair

Janette Benaddi MICR CSci

Like most organisations, the Institute has experienced a difficult operating environment this year, caused by the global recession. However, the Board of Directors and Senior Management Team (SMT) took early, proactive steps at the beginning of the year to manage us through the recession. These included a thorough overhaul of our operating costs and we are starting to see the benefits of these actions. Janette thanks you, our members, for your continuing support. We have received many communications from you supporting ICR over recent months, as we have gone through the change management process. The staff are extremely encouraged by this.

It’s Not All Work, Work, Work…

Compiled by Andrew Smith

Our regular look at the lighter side of clinical research, including some ideas for blockbuster movies involving clinical research, examples of “frontier science” in literary classics (and the new Dan Brown), and “Ten things that suggest global clinical research is starting to pick up again…”.

Cartoon for October’s issue of CRfocus

Prothero didn’t believe in these new-fangled feasibility studies and rankings to decide where to site clinical studies...

For more clinical research humour visit http://www.icr-global.org/crfocus/clinical-research-jokes/

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”.