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.

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 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(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…”.

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”.

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

CRfocus: Table of Contents of May issue

This is the Table of Contents of Clinical Research focus 20(05) for May 2009. Members of The Institute of Clinical Research can click on the links to read the full text of each article.

Features

Strengthening Protection of Research Subjects: The 2008 Revision of the Declaration of Helsinki

John Poland FTOPRA

The Declaration of Helsinki was developed to underpin the ethical conduct of human clinical research. Eight years after its previous major update, which prompted two clarifications on contentious points, the Declaration was revised late in 2008 after a process lasting nearly 2 years. John Poland provides a detailed view of the latest revisions, which have provoked mixed responses from regulatory, ethics and clinical communities.

Lost in Translation? Challenges in Preparing Participant Information for Multilingual Studies

Nicky Dodsworth MICR CSci & Efraim Roe

An increasing number of studies are being performed in parts of the world whose first language is not English. There are challenges in translation and communicating science in a multilingual world dominated by the de facto language of English. Nicky and Efraim look at the issues surrounding translation of the patient information and informed consent forms.

People

A Career Championing UK Clinical Research: An Interview

Richard Tiner

Richard Tiner steps down as Medical Director of the Association of the British Pharmaceutical Industry (ABPI) at the end of May, after nearly 13 years in the post. Over that time, he has been a prominent speaker at ICR events, and was the first person we interviewed for CRfocus. As he prepares to move on, he reflects on the changes in the UK clinical trials landscape since the mid-1990s, in which he has been instrumental.

National update

Local & National Perspectives on Streamlining R&D: ICR Scottish Forum

Mary Mumford RICR

Mary reports on the October 2008 meeting of the ICR Scottish Forum. At the meeting, Dr Janet Messer, Deputy Director of the NHS R&D Forum, gave an overview of the initiatives to integrate and streamline R&D activities throughout the NHS, while Brian Rae, R&D Manager of the Greater Glasgow & Clyde NHS Trust, spoke about the successes and challenges in developing world-class clinical research structures in one of the most health-challenged regions of the UK.

Professional development

Spice Up Your Interview Technique

Shanoo Singh

Being interviewed can be a nightmare. Interviewing skills have been rapidly and continuously changing over the past decade. Having been both a candidate and an interviewer on many occasions, Shanoo reaches out to everyone, particularly those seeking their next strategic positions, and offers some tips on how to perform at your best in an interview situation.

Viewpoint

Always Compete on Value; Never on Cost

Andrew Smith

When the economic upturn comes, the individuals, organisations and indeed countries that will be best placed to succeed will be those that have continued developing through the lean times. As an industry, we’ve become very good at working costs out of our processes. However, focusing solely on this risks neglecting importance of creating additional value for companies, shareholders and society as a whole. The relative risk of trying to leap ahead through strategic innovation is actually lower now than in ‘boom’ years, those that innovate and survive will secure their place at the forefront of the industry for a generation.

Devices, Drugs, Directives & Directors

John Kolthammer HonFICR

To recognise that our new Chair of the ICR Board of Directors has a background in medical device development, John Kolthammer, former CEO of ICR, offers a respectful and somewhat light-hearted reminiscence to draw attention to the some of the interesting issues that have always been present at the interface between pharmaceuticals and medical devices.

Regular update

Uncertainty & Opportunity: Message from the Chair

Janette Benaddi MICR Csci

Janette inspires us to remain optimistic and look harder than we have ever done for opportunities, despite any current financial insecurities or media-fuelled gloom. To add personal despondency to this will surely reduce our individual ability to cope, and will probably also make the wider recession both longer and deeper. It’s challenging to look on the bright side, but she believes that there is a bright side for many of us, if we care to search for it.

It’s Not All Work, Work, Work…

Compiled by Andrew Smith

Our regular look at the lighter side of clinical research, including “Ten innovations that won’t add value to sponsors, shareholders or society” and engaging with patients in language that is a bit more “street”…

CRfocus: Table of Contents of April issue

CRfocus 20(04) – April 2009

This is the Table of Contents of Clinical Research focus 20(04) for April 2009. Members of The Institute of Clinical Research can click on the links to read the full text of each article.

Weathering the storm

Consolidation or Sea Change?

Andrew Smith

In the current economic climate, it’s easy to reach the conclusion that the recent high-profile mega-mergers (eg, Pfizer/Wyeth, Merck/Schering-Plough etc.) are simple industry consolidation. But, as we’ve pointed out in CRfocus previously, the link between the global economic turmoil and the changes in the pharmaceutical industry is perhaps less direct than one might think. Andrew explores…

What a Difference a Year Makes: Survey of Executive Confidence

Tim Ewbank

The past 12 months have seen economic turbulence on a scale no-one could have predicted. So how has this impacted on the pharma and biotech sectors? Harten Group’s seventh annual industry survey takes a look at the facts behind the headlines. Tim Ewbank presents some of the findings of this research.

Maintaining a Positive Outlook: Survey of Jobseekers

Jonathan Hart-Smith

Following a recent survey at the beginning of 2009, jobseekers within the UK pharmaceutical and biotechnology industries have a very positive outlook. Their positivity is a breath of fresh air in stark contract to the general mood for the economies of Western Europe and the USA. Jonathan Hart-Smith presents the findings of this survey.

Research integrity

Investigating Serious Non-Compliance: Planning & Conducting For-Cause Audits

Nigel Crossland FICR Csci

A for-cause audit is defined as an independent and objective examination of a clinical research study in order to confirm the circumstances of a reported incident of serious non-compliance. In this article, Nigel describes some of the principles and practicalities involved in ‘for-cause audits’ and shares some examples of their findings.

Research Integrity: A European Perspective: EFGCP conference report

Andrew Smith

This year’s EFGCP Annual Conference, held in Prague at the end of January, aimed to provide a European perspective on integrity in the conduct and publication of clinical research. Andrew was there, and presents commentary on selected presentations, as previously reported on the CRfocus blog.

Book review

“The Trouble with Medical Journals” by Richard Smith

Reviewed by Debbie Early MICR

Prof. development

Tools & Updates: CTA Workshop Report

Judi Eaton

Judi reports on the latest ICR CTA workshop, aiming to give CTAs everywhere ‘Tools & Updates’ as part of the ‘Maximise Your Potential’ series. Topics included the draft CTA Handbook, a regulatory and ethics update and the ongoing development of the Integrated Research Application System (IRAS).

Regular updates

Our Institute, Our Future: Message from the Chair

Janette Benaddi MICR Csci

In her first message as Chair of ICR, Janette pays tribute to her predecessor, Susan Ollier, and sets out her vision for the coming year. During difficult times, it is important that we continue to support you in your careers and ensure that we are meeting your expectations. Janette explains that we are going to embrace these challenging, changing times and continue to add value to the services we provide for members of ICR.

It’s Not All Work, Work, Work…

Andrew Smith

Our regular look at the lighter side of clinical research, including “Ten things we hope sales & marketing won’t say to clinical” and engaging with patients in a “hip hop stylee”…