CRfocus: Table of Contents of March issue

Making up for the delay with February’s Table of Contents, here is the Table of Contents for the March issue of Clinical Research focus 20(03). Members of The Institute of Clinical Research can click on each link, and log in to read the full article. If you want to become a member of ICR, visit www.icr-global.org/membership for more information.

Patient recruitment & retention

Adjust the Focus on Recruitment & Retention: Enabling CRAs to Develop & Implement Site-Specific Plans

Sherry Armstrong-Wilkinson MICR

If you want recruitment and retention to succeed, then it’s time to adjust the focus on where investment is made. When selecting and training CRAs, how much time and investment do we put into developing skills and expertise that will allow them to support sites fully in the development of robust and strategic recruitment strategies? Sherry explains how a strong, dynamic relationship between investigators and CRAs is crucial for optimal site management and is vital for devising and implementing successful site-specific strategic recruitment and retention plans.

Exploring Patient Recruitment: NIHR Primary Care Research Recruitment Methods Group

Elaine Ward, Julia Miller & Brendan Delaney

As government policy is encouraging a larger number of patients to be seen by clinicians in the community, more clinical research studies require some recruitment in primary care. The Research Recruitment Methods Group came together in 2007 in a bid to begin to tackle recruitment barriers in primary care. Between them, the members of this collaborative group have had considerable experience of research conducted in general practice settings. Their aims are to improve delivery of clinical trials by exploring the factors which affect recruitment and then to develop a programme to systematically test the impacts of those factors. The authors discuss this group’s past, ongoing and future activities.

Factors Driving the Evolution of Digital Outreach for Patient Recruitment

Gaynor Anders, Mary Schwarz & Jake Perez

Most are aware that the role of digital media, particularly the internet, in recruiting patients for clinical trials has been steadily expanding in both availability and acceptance worldwide. But, what has driven the emergence of digital outreach for patient recruitment and where is it headed? The authors take a brief look at how we arrived at the present use of digital media in patient recruitment and look ahead to its future applications. They also consider the driving forces for both the past and future evolution of digital outreach for patient recruitment and the implications for the clinical trial landscape.

Planning for Success in Patient Recruitment: An Interview

Missy Orr

Missy Orr is Executive Director, Sites and Patients Services at PPD. Missy joined PPD in 2003 and oversees the global operations of patient recruitment activities. In this interview, we break down the component parts of patient recruitment, discuss why an approach might be successful in some places but not in others, and consider that patient retention doesn’t get the attention it deserves. An audio version of the complete interview is available to download.

Features

Real World Data: An Important Addition to Your Late Phase Development Plans

Samantha Marshall

Traditionally, ‘real world’ observational research has been criticized for lacking the robust scientific methodology of RCTs. However, with the shift in NHS requirements, the focus of clinical development needs to change to ensure a well-rounded development plan that includes not only RCTs but also more pragmatic research in real clinical practice. Samantha explores…

Health Technology Assessment in the UK & EU: NICE & EUnetHTA Conferences

Alan Jones

Alan gives us our regular update on the latest developments in Health Technology Assessment, how it impacts on reimbursement for the medicines and devices we help develop, and how its importance will only increase for people designing and conducting clinical trials. This extended version of the article includes more detail on both the NICE and EUnetHTA conferences than was possible in the printed version.

Viewpoint

Research Integrity vs Getting the Joke

Andrew Smith

Were ‘cellist’s scrotum’, ‘guitarist’s nipple’ and the PIGPEN study on the treatment of headlice simply a bit of light relief for overworked physicians, or dangerous distortions of the scientific record… or even disease mongering? Andrew eschews his usual humorous streak to suggest that unacknowledged hoaxes in primary medical journals might not be a great idea…

Regular update

So Long, Farewell, Auf Wiedersehen, Goodbye…: Message from the Chair

Susan Ollier MICR Csci

Susan Ollier, Chair of ICR until she reaches the end of her term of office at the Annual General Meeting on March 17th, looks over some of our recent achievements, thanks those who have made it all possible, and says a fond farewell to the colleagues and friends she has met along the way.

CRfocus: Table of Contents of February’s issue

A little late in the month once again, I’m afraid, but here is the Table of Contents for February’s issue of CRfocus, 20(02). Members of The Institute of Clinical Research can click on each link, and log in to read the full article. If you want to become a member of ICR, visit www.icr-global.org/membership for more information.

Enhancing NHS research

Inside IRAS: ‘Real World’ Experiences with the Integrated Research Application System

Susannah Radford

The Integrated Research Application System was designed to facilitate a more streamlined approach to gaining approvals for clinical research in the UK. Susannah interviewed users from mid-November to early December 2008 to find out how they were finding version 1.0 of system. She also reports on some of the changes made in IRAS 2.0, launched late in December.

Streamlining Device Study Contracts: A Model Agreement for Medical Technology Investigations Carried Out in NHS Trusts

Jill Dhell & Mark Lewis

In recent years, collaboration between the NHS and both the pharmaceutical and medical technology manufacturing industries has been high on the agendas of the Departments of Health and the UK industry trade associations. The publication of the model Clinical Investigation Agreement for studies carried out in the NHS is the latest development of this type. Jill and Mark explain…

Building Clinical Research Capability in Nottingham: An Interview

Brian Thomson & Darren Clark

Andrew Smith interviews Dr Brian Thomson, Director of R&D at Nottingham University Hospitals NHS Trust, and Dr Darren Clark, CEO of Medilink East Midlands about initiatives to build capacity and capability for clinical research in the Nottingham area.

Impact of the EU Directive

The Impact of the EU Clinical Trials Directive: Report from the ICREL Conference

Andrew Smith

Industry and academia alike are calling for the EU legislative environment to be changed; however, there had not been a formal assessment of its practical impact across all stakeholder groups. The Impact on Clinical Research of European Legislation (ICREL) project has produced these metrics, and Andrew Smith reports from a conference held to present and discuss the project’s preliminary results.

Measuring the Impact of the EU Clinical Trials Directive: An Interview

Ingrid Klingmann

Shortly after the ICREL conference, Andrew interviewed Ingrid Klingmann, who coordinated the project. She explains some more of the background, discusses some of the more unexpected findings and looks at the potential next steps.

Ten Things…

Ten Things You Need to Know About Phase I Clinical Trials

Harriet Wibberley MICR & the ICR Clinical Pharmacology SIG

In this series, experts provide introductions to topics that are becoming increasingly important. This month, we provide ‘bite-sized’ guidance on Phase I clinical trials. If you want to request a topic to be covered, or submit your own “Ten things…”, please email editorial@crfocus.org.

Prof. development

Pharmacy as a Career in Clinical Research

Caroline Bedford MICR & Sheila Hodgson MICR

Pharmacy staff do much more than ensure safe storage of clinical trials supplies. Because of their training and experience, pharmacists and pharmacy technicians are well placed to pursue a career in clinical research. Caroline and Sheila, both members of the ICR Pharmacy SIG, explain some of the career paths and options for pharmacy technicians and pharmacists.

The Insider’s Guide to Being a Successful CRA/Monitor

Lynn Seeley MICR & Irene Lee MICR

Delegates gave positive feedback after attending this workshop, hosted by the ICR CRA Special Interest Group (SIG) at Birmingham City University on September 25th 2008. Speakers represented the Medicines and Healthcare Products Regulatory Agency (MHRA) inspectorate, United Kingdom Clinical Research Network (UKCRN), research nurses, study site managers, pharmacists and Clinical Pathology Accreditation (CPA) Ltd. Lynn and Irene report…

Viewpoint

Unthinkable!?

Andrew Smith

A recession can actually be a great time to be innovative and entrepreneurial. If this can (and does) happen in the wider sphere of business, Andrew argues it can (and should) also happen in the development of new medicines.

Regular update

Raising Big Issues in High Places: Message from the Chair

Susan Ollier MICR CSci

In her message this month, the Chair of ICR explains how we will be working with our newly-appointed President, Lord Howe and the All-Party Parliamentary Group on Medical Research to ensure that the issues that are important to you are raised at the highest political levels, and how we aim to appoint a Vice-President with a similar remit outside the UK.

Contents of November’s CRfocus

To read the full text of each article, click on the link and log in as a member of The Institute of Clinical Research

CRfocus 19(10) – November 2008

Medical devices

Is a Trial Necessary? Evaluating Clinical Evidence for Medical Devices

Janette Benaddi MICR

It is widely accepted in the device industry that in many cases, and with some particular devices, it is not necessary to conduct a clinical investigation in humans to be able to obtain the CE mark for a product. Janette explains the rigorous process of Clinical Evaluation, and when and how it can be applied instead of a Clinical Investigation.

Adverse Events & Reporting Criteria for Medical Devices

Lorna Stewart MICR

As in the pharmaceutical industry, patient safety is the prime concern of medical device manufacturers and this applies throughout the product lifecycle, from development and clinical investigation to the post-marketing environment. Although many readers will be familiar with the requirements as they relate to pharmaceuticals, they are subtly different for medical device adverse events. Lorna explains…

Features

Hitting the Target: Using Data-Driven Tools and Analysis to Improve Patient Recruitment

Joshua Schultz

Patient recruitment is a major challenge for every pharmaceutical company and CRO. To overcome this challenge, trial sponsors must be able to accurately predict trial recruitment rates, select sites with the greatest recruiting efficiency, and respond quickly to recruitment issues at each site once trial start-up is underway. Powerful new tools are available to help forecast recruitment trends and analyse site performance, but they must be implemented properly to achieve maximum benefits.

Good Publication Practice 2: Responsible & Ethical Clinical Publications a Decade On

Chris Graf & Elizabeth Field

In the ten years since the original Good Publication Practice (GPP) guidelines were conceived, the development of a publication strategy for a new investigational product has changed from being a ‘nice idea’ to almost being an imperative for any pharmaceutical or biotech company. With all that has happened, it’s safe to say the time is right for GPP2: a new, revised version of Good Publication Practice. Chris and Betts explain the development process and how you can help.

Small Doses, Large Insights: Inside Microdose Studies

Ashley Brooks, Paul Allen & Joseph Chiesa FICR

Up to half of all compounds entering clinical development fail because of unexpected pharmacological effects in humans. This often presents as poor tolerability, unwanted effects or poor pharmacokinetic (PK) profile. Microdose studies enable the human PK profile of new chemical entities and their metabolites to be characterised before conventional Phase 1 studies are carried out. This approach can accelerate and increase the efficiency of the drug development process.

Partner promotion

Security for Clinical Research Freelancers

Andrew Catton

In an increasingly litigious and contractually onerous world, professional liability of independent consultants can create barriers to conducting business. Andrew Catton of presents a specialist insurance scheme for freelance CRAs and CTAs, exclusively for ICR members.

People

Project Management in Clinical Research & Beyond: An Interview

Roger Joby & David Bryde

Roger and David have both published and lectured on management of clinical research projects, including on ICR’s MSc in Clinical Research. They discuss the changing discipline of project management, why excellent CRAs sometimes become mediocre project managers and the myth of the fixed-price contract. A complete audio version of this interview is also available.

Prof. development

ICR Members Helping Each Other

Michelle Noble

Some of you may have heard of and know a little about the ICR Special Interest Groups (SIGs) and Steering Groups but only a few of you will be fully aware of how much time, effort and work these people devote to the good of the entire ICR membership. Michelle explains…

Viewpoint

Who’s Buying, Who’s Selling? And Will It Make Any Difference?

Andrew Smith

The current problems facing many businesses could be used as an opportunity for pharma to open their ‘war chests’ and snap up some acquisitions to bolster pipelines (and share prices) for far less than might otherwise have been the case. This is because big pharma companies are generally less ‘leveraged’ than many other industry sectors, particularly in comparison with their venture capital-funded colleagues in small biotech companies. But how much will actually change for us down ‘at the coalface’? Andrew ponders…

Regular updates

Unity in Diversity: Message from the Vice-Chair

Gareth Hayes HonFICR

The variety of opportunities today is endless and everyone is making a pitch to continue the diversification. But this can be both a blessing and a curse when it comes to attracting new graduates into clinical research. With a myriad job titles springing up to describe specialist roles, and sometimes meaning different things in different organisations, Gareth asks whether we are gradually getting a handle on how to handle graduates…