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

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

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

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

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

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

If you can only go to one conference…

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

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

Plenary sessions: Personalised healthcare & Health economics

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

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

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

Parallel sessions: From patient recruitment to research governance

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

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

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

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

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

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

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

Annual General Meeting: May 19^th

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

More targeted exhibition

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

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

Make the most of your membership

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

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

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…

Some perspective on the current “AIIMS paediatric clinical trial deaths” story

Many media outlets and blogs are frothing over the news item about 49 babies dying in clinical trials at the All India Institute of Medical Sciences (AIIMS). However,over at the PharmHouse, Seeji provides some much-needed rationality and perspective on the story.

Why not go over there and read what he says…

My comment to his post reads: “Thank you and well done for posting a bit of rationality amongst all the media hysteria surrounding this news item.

“Some of the reports I’ve read state that the mortality rate for all patients treated at AIIMS (not just children) is 4%. Between this and your data of national infant mortality of 5-7%, the 1.2% mortality rate in this data is surprisingly good. If you extrapolate from these (very rough, I know), the expected number of deaths should have been between 165 and 290. However, I can’t imagine the mass media rushing to use a headline like “Over 100 babies saved by taking part in clinical trials”!

“The other key point that the mass media appears to have missed is that it is surely better to treat children with medicines that have been explicitly studied in other children, not simply prescribed off-label based on extrapolations from studies conducted in adults. Children’s physiologies are very different from those of adults. It is even more of a scandal than this claims to be that as much as 70% of prescriptions to children are off-label because insufficient paediatric studies have been carried out. This is a situation that the USA and the EU have started to put right with legislation over the past decade.

“It is disappointing that every other report or comment that I’ve seen on this item takes a sensationalist view rather than your more rational one.”

Guidelines in Review

Birka Lehmann of BfArM chaired a session on guidelines in review. She opened the session with discussion of the Paediatrics regulation. The paediatric committee (PDCO) has set up 7 subcommittees to produce consider guidelines for specific disease areas. They have already decided not to produce entirely new guidelines where they already exist in adults, but will adapt these guidelines where possible, looking for situations where findings from adult research can be used to inform paediatric research. This is particularly concerned with the selection of an appropriate endpoint. She then introduced Dr Kevin Blake of the Irish Medicines Board and a member of the CHMP-Efficacy Working Party, to give an update on the guideline on obesity and weight control. These guidelines were adopted late in 2007 and will come into effect in May 2008. He looked at some of the contentious issues during their development, and gave some suggestions on how they should be interpreted. The CHMP-EWP advises the CHMP under EMEA/P/24143/2004 and produces guidelines which, although not binding, are highly recommended. The new obesity guideline is CPMP/EWP/281/96 revision 1. He talked us through the timeline of its development, from April 2006 through to its adoption in November 2007. The group defined obesity in adults as a chronic clinical condition that needs long-term therapy, based on the WHO definitions. Dr Blake mentioned that comments were made on racial differences in definition of obesity, which were indeed included. The guideline acknowledged non-pharmacological options under certain conditions, but primarily discussed the pharmacological options, to be used alongside a calorie-controlled diet. Comments related to pulmonary artery hypertension risk with centrally acting anorectic agents. As weight loss can be controlled by behaviour modification alone, the dropout rate in pharmacological studies is high. As a result, they recommend a placebo group to be compared on dropout rate as well as efficacy. However, he suggested that dropouts should be followed up, to base the analysis on the full ITT population, asking participants to at least notify triallists of their weight after 1 year. Participants who withdraw their consent can make this difficult, so great care must be taken when obtaining initial consent. In terms of primary endpoint, they defined it as at least 10% of baseline weight from the start of the run-in period, and at least 5% greater than associated with placebo (with appropriate loss of body fat demonstrated). Comments to this questioned whether 5% weight loss might be appropriate in specific conditions (eg, comorbid diabetes); this was accepted, provided this subgroup of patients is pre-identified. Another query asked whether a change in concomitant medication might be acceptable as a secondary endpoint, but this was rejected. Moving to patient selection, the guidelines require a BMI >30 in otherwise healthy adults. Kevin had already mentioned a degree of controversy over run-in periods. Comments had questioned whether this was necessary, but he stated that it was crucial to establish a behavioural pattern and confirm motivation. This alone would skew the baseline, but this is overcome by taking the baseline from the start of the period. In the development of the addendum under development on paediatric obesity. This does not use the adult definition, nor the classical US definition, which are based on arbitrary cut-offs. Instead, it uses a statistical model based on pooled international data to link accepted adult cut-offs back to younger ages. Treatment goals are composite, encompassing age, stage of growth degree of overweight and presence of associated comorbidities. Halting or decreasing the rate of weight gain could be primary endpoints, while weight loss could be a primary endpoint for subjected with related complications. On selecting a trial population, children over 6 should be selected (split into pre- and post-puberty), with a run-in period of 3-6 months and only children not achieving adequate weight loss in this period being entered into the active study.