OLS Blueprint: PICTf 3.0?

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

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

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

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

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

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

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

Cartoon for September’s issue of CRfocus

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

Cartoon for September's issue of CRfocus

Should ICH GCP be reviewed and revised?

ICH guideline E6 (ICH-GCP) is, along with the Declaration of Helsinki, arguably the most important document in clinical research. Although neither has any direct status in the legislation of most countries where clinical research is conducted, their principles (and in many cases more substantive details) set the tone for how pretty much everyone conducts 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.

Since 1996…

The world of clinical research has moved on quite some way in the past 13 years, and even more so when you consider the period of several years that was taken for the drafting, consulting, reviewing and negotiating prior to the guideline’s finalisation. Other guidelines (most notably the Declaration of Helsinki) have been updated several times in the past decades, and have a timeline for regular review every few years.

So, following a remark made by a speaker at the ICR Annual Conference earlier this year, we wondered whether ICH E6 should be reviewed and potentially revised. We put a poll on the front page of the ICR website, and were rather surprised by the result: over 80% thought that it should be reviewed (although from an admittedly small sample). We are currently undertaking a qualitative survey, asking what elements of the guideline should be updated and/or what should be added that did not exist in 1996. We hope to publish this in September’s issue of CRfocus magazine. If you would like to share your thoughts on this, and contribute to our article, please send your comments to andrew.smith@crfocus.org no later than August 10th 2009.

Of course, this is to an extent a purely academic exercise: many of the assorted national legislations, EU Directive etc. are subtly different, and the feasibility of renegotiating such a complex document with so many stakeholders (not least the more recently research-active countries that are outside the formal ICH process) is highly questionable. Indeed, some contend that the national legal arrangements have become so much more formal and sophisticated than they were in the 1990s that any thought of change to a founding guideline like ICH GCP is futile.

Still, it is useful to consider what aspects of contemporary clinical research are poorly served by the current fragmented global network of regulation and guidelines, and how different ICH GCP would look if it were being created in 2009. I’m interested to hear what you think…

End of term reports?

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

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

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

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

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

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

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

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”…

Always Compete on Value; Never on Cost

The title was a maxim drummed into me at the start of my career. I’ve said before, as have many others, that a recession is not something to be simply ‘ridden out’, but as far as possible to be invested through. 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. Others, who might have survived by pulling in their horns, will need to adapt suddenly to an environment that has changed commercially, socially, demographically and scientifically. Simply minimising costs will not be enough.

We’ve seen wave after wave of initiatives to improve the efficiency of processes and as a result we’ve become very good trimming a few percentage points off the cost of delivering a study. If what’s important is completing Study X within budget, then this is ‘a good thing’, and many feel that this is the case. The problem is that it’s tempting for organisations to focus too exclusively on cost minimisation. When you’re very good at using a hammer, everything looks like a nail. However, this neglects the bigger picture and the importance of creating additional value for companies, shareholders and society as a whole.

In the short term, quality is better at creating value than cost minimisation. Data obtained cheaply but that is not robust is of no value, with rework outweighing any cost savings. (Improving quality to eliminate rework is one way that techniques such as Six Sigma reduce costs.)

In the medium term, speed is better at creating value than cost minimisation. For a treatment that makes it to market, a few extra months of on-patent sales will be worth far more than thousands of pounds saved during Study X. For a treatment that isn’t going to succeed, being able to make that decision earlier eliminates the cost of Studies Y and Z.

In the long term, strategy is better at creating value than cost minimisation. By far the best way to create value is to get better at planning the development programme. Compounds entering development now will face different challenges to demonstrate safety and efficacy, scientific developments enabling more precise targeting of responders and non-responders, traditional markets seeking more detailed analysis of socio-economic impact to justify pricing, new markets increasing dramatically in importance and patients being more vocal in specifying what they want from a treatment. Many of these factors will influence or even contradict each other, making it vital to have a detailed and integrated understanding of the entire picture. While some of these strategic insights will come from the clinical/regulatory sphere we are all familiar with, others will involve experts in economics and marketing.

Maximising value and minimising cost certainly aren’t exclusive. It could be argued, for example by CROs, that as long as someone is thinking about the bigger picture, then it’s okay to concentrate solely on containing costs. However, that’s could be short-sighted, because having efficient processes is of little long-term value if they can’t cope with the changing goals of future development programmes. In fact, with a broad view and portfolio of clients, being able to offer such strategic insights could be a deal-winner.

It might seem counter-intuitive, but when the overall level of business risk is high, the relative risk of trying to leap ahead through strategic innovation is actually lower than in ‘boom’ years. Some companies will fail, but some will fail anyway, and those that innovate and survive will secure their place at the forefront of the industry for a generation.

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”…

Consolidation or Sea Change?

Less than a month after Pfizer bought Wyeth for $68bn, today’s big merger news is that Merck will buy Schering-Plough in a deal worth $41.1bn. In the current economic climate, it’s easy to reach the conclusion that this is simple industry consolidation, with the cash-rich companies opportunistically buying up those less fortunate, integrating the businesses and continuing as before. 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…

Analysts have argued that the pharmaceutical industry is one of those least threatened by the global recession: big pharma companies are less highly leveraged (ie, funded by debt) than their comparators in other industries, many have substantial cash ‘cushions’, and share prices already reflected investors’ knowledge of the impending ‘patent cliff’ facing many companies in the next few years. Indeed, you could expect the sector to outperform overall stock markets as investors flee other ‘blue chip’ industries (eg, financial services, automotive industries etc.) that are suffering the brunt of the crisis.

So, if this isn’t a ‘fire sale’ to prevent Company X from going under (which, at these prices, it clearly isn’t), then why are these mega-mergers coming thick and fast at the moment? My view is that it’s a rush for a ‘critical mass’ of intellectual property, bargaining power and cash. The goal is to propel big pharma from the “invent it here, develop it here, sell it here” model that was the only game in town 20 years ago to the “license in candidates, contract out development, manufacturing and sales” model that’s been discussed in recent years as the only way to make big pharma sufficiently diverse and agile for the future. In the short term, this requires a pipeline broad enough to navigate the patent cliff safely, with key patents on many high-earning drugs expiring in the next couple of years. In the longer run, though, access to huge quantities of resources is vital, to manage such a deep strategic change while mitigating the operational shock and potential brand damage of changing how tens of thousands of people and their associated infrastructure are deployed.

I’ve previously commented that these changes of ownership will make relatively little difference to how clinical research itself is conducted: scientific requirements and professional standards are unchanged, and there is still more demand for clinical research than there are professionals to perform it (or patients, for that matter, but that’s another story…). Company cultures will differ, as will the precise nature of the SOPs to meet these professional standards and scientific requirements, but we will mostly be doing the same tasks, albeit increasingly in the CRO sector rather than within pharma.

This could make work more complicated, as the ground rules of successive studies change subtly as we work with a wider variety of sponsors, on studies that are getting increasingly complex anyway for unrelated, medico-economic reasons. However, it should also make life more interesting, as we work in a diversity of therapeutic areas.

So, is all of this a ‘good thing’? I’d have to say that it is, because the expiry of key patents is the ‘elephant in the room’ throughout the pharmaceutical industry. We may be well placed, as a sector, to ride out the current turbulent times but our own crisis was looming well before the financial services industry started crumbling. The political appetite for bail-out funds will almost certainly be gone before anyone in our sector needs one, so we need to take advantage of this opportunity to change the way our industry is organised.

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.