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 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.

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.

A message from our sponsor…

The CRfocus blog is pleased to be sponsored by the Institute of Clinical Research 2009 Annual Conference & Exhibition.

ESSENTIAL UPDATES

AND LIVELY DEBATES

ICR understands the importance of maintaining your competitive edge in the current environment. Therefore, this year’s conference is packed with opportunities to hone your professional skills, stay abreast of the latest regulatory developments and keep up to date with the hottest innovations in the clinical research industry.

There will also be plenty of opportunity for you to make new contacts and network with influential figures from across the industry.

Programme highlights include:

• Essential regulatory updates, plus “GCP Question Time”
• Intensive half-day sessions on oncology, organ transplants & cardiovascular medicine
• Lively discussions on EDC, off-shoring and global contracts
• New Professional Development stream with certificates & CPD points
• Debates on controversial questions with the chance to vote

For details of how to register and to view the full conference programme click here

CRfocus: Contents of December’s issue (vol. 19 no. 11)

Apologies that this is appearing a few weeks late, because of the illness through much of December, leading up to the Christmas break. December’s issue of CRfocus (vol. 19 no. 11) was published on December 8th 2008, and included the following articles. Members of The Institute of Clinical Research are able to click through these links to read the full text of the articles.

Future of Clinical Research

The Future of Clinical Research: Predictions & Hopes from Across the Clinical Research Community

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.

Feature

Are We Speaking the Same Language?: ICR Project Management Forum

Tanya Palmer MICR

In our business- and technically-focused work environments, we often fail to take into account the impact of culture, either through oversight or simply due to a lack of training. This forum aimed to give us the tools to put this right, and Tanya reports…

What Every Freelancer Should Know! ICR Freelance Forum

Helen Glenny HonFICR Csci

Helen Glenny reports from November’s meeting of the ICR Freelance Forum, which discussed tax status, GCP and FDA inspections, pharmacovigilance and a regulatory update

The Who, What, When, Where & How of Investigator Site Training: ICR Trainers’ Forum

Sue Matthews MICR

The ICR Trainer’s Forum showed excellent attendance, with 85 enthusiastic participants turning up on October 8th, to listen and discuss as well as participate in a workshop on investigator site training within clinical research. Clearly, this was a subject of interest and importance with representatives from pharmaceutical companies, CROs, NHS and academia attending.

Stem Cell Research & Neurodegenerative Diseases: ICR Innovative Medicines Forum

Frances Sanders RICR & Rosalyn Forsey RICR

The second Innovative Medicines SIG forum of 2008 addressed the topic of stem cell research and its potential for use in the treatment of neurodegenerative diseases. The meeting provided an excellent insight into the fascinating and complex world of stem cells.

Partnership in Clinical Trials: Conference Report

Andrew Smith

The “Partnerships in Clinical Trials” took place in Berlin on November 5th and 6th, to discuss issues related to the globalisation and outsourcing of clinical research. This report presents highlights of some of the sessions, based on live coverage of the meeting on the CRfocus blog.

People

Breaking the Mould: An Interview with Neelam Patel

Andrew Smith interviews Neelam Patel, Clinical Operations Manager at Lilly UK. They discuss her unique career path, innovation in the way Lilly is conducting clinical research, the challenges of resourcing studies and the evolving role of the CRA.

Professional development

Book Review: Are You Thinking of a Career in Regulatory Medical Writing

Reviewed by Samantha Hamilton

Book Review: A Quick Guide to Clinical Trials For People Who May Not Know it All

Reviewed by Joy Dummer MICR,  Jessica Giles & Lynda Golightly RICR

“If You Raise the Water Level, Everybody’s Boat Floats!” Increasing the Talent Pool Resourcing Clinical Trials

Linda Powell & Greg Holt

There is no shortage of examples illustrating creative methods of attracting and retaining skilled staff in today’s challenging marketplace. As candidates are required to ‘hit the ground running’, competition between companies is fierce to entice experienced clinical research professionals. Linda and Greg discuss…

Regular update

Benefits for ICR Members… and Who Else? – Message from the Chair

Susan Ollier MICR

Susan Ollier discusses who benefits from ICR’s existence, and suggests that it’s not just us, the members. In improving the conduct of clinical research, we are delivering public benefit, and perhaps we are too reticent about communicating this.

CRfocus 2008 Article Index

Partnerships in Clinical Trials

Just a quick note to say I’ll be blogging from the Partnerships in Clinical Trials conference taking place in Berlin next week… if I can get my travel arrangements sorted out in time!

If you’re going to be there, do look me up to say hello…

Are you going to ICPM next week?

I’m still juggling my diary and travel plans, but I’m hoping to make it along to at least part of the 15th International Conference on Pharmaceutical Medicine (ICPM), held in Amsterdam in the first part of next week.

In a packed 3 day programme, the International Federation of Associations of Pharmaceutical Physicians (IFAPP) and it’s Dutch association the Nederlandse Vereniging voor Farmaceutische Geneeskunde (NVFG) will be mapping out the current state of the art in areas including:

• Translational medicine
• Trial design
• Post-marketing research
• Off-label pharmacotherapy
• Outsourcing
• The evolving system for getting new drugs to market

The meeting will also see the formal launch of the Dutch Medicines for Children Research Network.

For more information, and to book a last-minute delegate place, visit www.icpm2008.org. If you are there next week, please do look out for me…

What We Want & What We Need

It’s an odd time for us, working in clinical research. The economies of the developed world are teetering on the edge of recession, many pharmaceutical companies are seeing their biggest money-makers reaching the ends of their patents, and as a consequence many of them are looking reduce their headcount and cost-base by out-sourcing activities, in-sourcing personnel and off-shoring studies to the emerging markets. Conversely, we are also facing a skills shortage (even in high-growth regions such as India), with experienced clinical research professionals in great demand and increasing competition to hire the best people. To help meet this demand, we’ve published an ‘extra’ CRfocus recruitment supplement in addition to ICR members’ 11 regular issues, bridging the gap between July and September.

The skills shortage over the past few years has weighted the balance of supply and demand in the personnel recruitment sector strongly in favour of candidate supply, but this balance is shifting. If handled carefully, this could actually be a positive thing for all involved in the long-term, rather than the negative scenario many perceive it to be.

The demand side of this equation (ie, the pharma companies) has been moving slowly over the past few years, with companies seeking more flexible staffing arrangements, albeit constrained by the pragmatic need for staff to work on the current portfolio of studies. The gap between what industry wants in the long term and what it needs in the short term widened during this period; companies have been robust enough to tolerate this up to now, but as the broader economy tightens, industry’s capacity to tolerate this gap is reducing, and the desire to increase flexibility is becoming a necessity.

On the supply side, candidates have made the most of being in demand over recent years, with experienced personnel getting almost whatever they want as an incentive to change employers. With the tightening of the economy, people are placing even more value on job stability and structured professional development, over rapid increases in responsibility and salary. (This is particularly true for the thirty- and forty-somethings who comprise the majority of ICR’s membership, in the “family-size” stage of their lives.)

With drivers for change on both sides of this equation, we can expect to see a turbulent time ahead in the recruitment market for clinical research professionals, in which everyone involved (including all the intermediaries, such as recruitment consultancies and media channels like CRfocus and our online job-board CRjobs.org) will need to be more creative in balancing the wants and needs of both sides of the supply/demand equation.

The fact that both sides of the equation are shifting also suggests that there is a ‘sweet spot’ to be found, although the pace of change risks overshooting this balance point and tipping too far the other way. Employers and employees need to find other areas in which to add value to working together. A recent podcast from the Harvard Business Review discussed ways to reward staff when simply paying them more is not an option. Its conclusions (flexible working to suit family commitments, personal and professional development, visible recognition of performance and involvement in areas of interest beyond the strict remit of the role) are hardly rocket science, but both recruiters and candidates need to consider them and make more use of them.

By having a broader discussion on these topics, both industry and individuals can get what we need, even if it does mean compromising a little on what we want.