Keith Rodgers on clinical project & programme management

Interview with Keith Rodgers

Keith Rodgers, expert in project management systems and current Chair of the Pharmaceutical Industry Project Management Group (PIPMG) speaks with Andrew Smith about project and programme management in clinical research.

“Rumours of the demise of European clinical research have been greatly exaggerated”

This is not the piece I anticipated writing when I sat down… For the past few weeks, I have been a false harbinger of doom! My apologies to everyone I have spoken to about a “sharp decline” in clinical research in Europe: I have led you astray and caused you undue concern… and all for the sake of insufficiently thorough research.

It all began in June when, on my routine check of the EudraCT website, I spotted that the latest batch of usage statistics had been published (https://eudract.ema.europa.eu/docs/statistics/EudraCT_Statistics_June.pdf). I looked specifically at the metric given for the number of new EudraCT numbers issued since the start of the year, as a reasonable surrogate for the level of clinical research activity around Europe over the coming 18 months. As a “half year” figure is mildly more reportable than other periods, I decided to compare this figure with those from previous years (https://eudract.ema.europa.eu/document.html#statistics). Imagine my surprise, not to say concern, when I worked out that the latest published figure was more than 70% down on the same period in 2010! Keen to check that the first half of 2010 hadn’t been a bumper year for EudraCT, I checked the same mid-point of the few years before that, and in each case found they were broadly similar.

So, in ICR’s weekly news bulletin and in conversation, I duly reported this “fact”, with the intention of writing a piece such as this to explore the reasons for this sharp decline. It was only when double-checking my figures before sitting down to write, that I spotted my error. I pulled together the published metrics for every month since January 2007, hoping to draw a neat trend against which the current figure would be a distressing contrast. I did find a trend: downward, by around 30% from 2007 to 2010.

But then I looked at the 2011 figures. For the first time, current metrics were broadly on-track with those from the previous year. In this context, the June figure that caused me such concern must surely be a transcription error (I have alerted EudraCT to my suspicion, and I expect that they will republish a corrected version of the report in due course), and it looks entirely possible that 2011 could be a turning point for clinical research in Europe. With the cost-gap narrowing between European sites and their competitors in other regions, and the European Commission and national governments alike entirely convinced of the need to streamline regulation and governance processes, it seems that the rate of sponsors leaving Europe to conduct their studies is slowing.

Of course, things will never return to the levels of activity that we saw in the 1990s and early 2000s: the “globalisation genie” is out of the bottle, and a significant proportion of research will continue to be done in the BRIC countries and surrounding regions (for good reason: there are plenty of patients there, who will take part in a clinical trials and, later, form the target market for the drug). But, on a closer analysis of the EudraCT metrics, rumours of the demise of European clinical research have been greatly exaggerated!

The Clinical Career Coach: Should I Stay or Should I Go?

Starting a new series, Jane Karsten “The Clinical Career Coach” shares her thoughts on how to think about your career development within the field of clinical research. Jane is a member of the ICR training team; alongside her expertise in clinical research skills, she is also a CBT Coach and NLP Practitioner. While some of the details have been changed to preserve anonymity, the scenario and suggested thought processes are true to life. Jane writes:

I was talking to a client, Susie, recently. She is considering her career path in clinical research. She is at a point where she wants to progress from a Senior CRA role to become a Clinical Trial Manager (CTM) and has seen an advertisement for a suitable vacancy with another company. However, there has just been a restructuring in her current company and a similar position may become available, but not within the next 12 months. What should she do? Stay where she is and hope a CTM role becomes available or apply for the job at the new company?

Inside the coaching process

The decision to change jobs isn’t made lightly. It’s a process, and for some a dilemma, that stirs up many doubts and fears. Is it better to stay where you are known and have built up your reputation? Will you be throwing away the efforts of the past few years if you decide to leave? You like the ethos of the company and have good working relationships with your colleagues, but are these the right criteria for staying?

Let’s look at the process I coached Susie through to help her to make the right decision on her career progression.

Rational analysis

Before talking about the new job role I wanted to understand Susie’s motivation for considering a new position. It is important to find out whether an individual is motivated towards a new role or they are feeling propelled to move away from their last position and if the latter what is making them feel like this?

Then we explored what she wanted to happen next in her career by asking the following questions:

• Let’s be specific, what precisely do you want to happen in what timeframe?
• What is it about the Clinical Project Manager role appeals to you?
• Does it fit with your personal goals?
• This led to a reality check, was she appropriately qualified for this role?

We discussed the required competencies for the CTM role and then reviewed the experiences from her work to date which would best demonstrate she had the skills and knowledge to perform this role effectively. From this, we considered any steps (in terms of additional responsibilities) she would need to take to best prepare for taking on the CTM role.

Having looked at the role we then explored the options of where to work.

• What are the good things about the company you are currently working in?
• What are the issues and concerns you have about your current company?
• Is there a good record of internal promotion or do they tend to recruit externally?
• What is the realistic chance of a similar role coming up within your desired timeframe?

Feel the fear… and do it anyway?

Having looked at the current company, let’s think about the alternative of leaving and going to a new company.

You have to be really honest here, how much is the fear of the unknown keeping you where you currently are? Are these fears real or are they as a result of outdated beliefs you may hold about yourself?

I had an experience of this last summer, when I was out on the Baltic Sea in a small motor boat. While I was cruising through familiar waters, I felt happy and relaxed as I believed I was safe. However, when I went round a headland and continued into a section of the sea I had never crossed before, I immediately became jittery, anxious and less relaxed.

Although the sea conditions in both areas were exactly the same, my perception and belief was that it was more dangerous, and as a result I felt more fearful in this new unknown area of water. There was no evidence to suggest that the waters I am familiar with were any safer and in fact the opposite may well be true. However, just the fact that I was used to crossing them on a daily basis was sufficient to make me believe I was safe and so felt happy and confident travelling across them.

So how does all this translate to job changes?

The first consideration is to ask yourself whether the familiar waters of your current company are as safe as you believe. You don’t have to look very hard in the pharmaceutical industry to see mergers, consolidations, downsizing and redundancies (eg, Pfizer, Novartis, Roche, Parexel, Kendle etc.) which create high levels of uncertainty and anxiety.

I had the experience, several years ago, of working through the merger of Sandoz and Ciba Geigy to form Novartis. It is not an easy process to go through and raised many feelings of anxiety and uncertainty. Suddenly, my familiar company had changed from feeling safe to becoming unknown. When you decide to stay in a company you are not guaranteed it will remain the same.

If you are feeling afraid about the “unknown waters” of a new company, ask yourself “are my fears about moving to a new company really valid, are they logical?” One of the ways to address this is find out as much as you can about the new company, so it becomes known to you, so you can make an informed decision:

• What is important for you to know about the company to help you make your decision?
• What aspects of that company do you need to become familiar with?
• Do you know anyone who is currently working there who you could ask about their experiences?

Once you have gained this information, how do you feel? If you are still feeling worried, you may have to be honest with yourself and ask a few more questions:

• What is holding you back?
• What is your biggest fear about moving?
• Are you afraid you may not be able to do the job?
• Are you worried you won’t fit in?

This is where talking with a coach is helpful as you may have some outdated beliefs which are holding you back from moving to the next step.

You may require expensive investment in training to move to the step on your career path. Is your current employer prepared to cover the training when there may be no suitable vacancy to make use of the training? Are you prepared to make that investment personally?

Be aware of your emotions, then trust your judgement

As I commented earlier the decision to change jobs isn’t made lightly. However, if you follow a logical process of asking yourself the questions highlighted in this article, I trust you will make the right decision for you.

Ask the Clinical Career Coach

If you have a dilemma about your professional development within clinical research, Jane might be able to ask your the right questions to help you decide which path to take. Write to her at jkarsten@icr-global.org.

CRfocus 22(3) – May 2011 – Table of Contents

ICR members can download the entire issue [login required] using our eCRfocus service.

Cover story

Early Phase Japanese Bridging Studies: Global significance & CRO Selection Criteria

Keith Berelowitz & Jörg Taubel

In 1998, Japan’s PMDA, adopted the ICH “Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data”. This, coupled with the acceptance of the PDMA in 2007 of clinical data from non-Japanese patients, has helped to bring NCEs to the Japanese pharmaceutical market in both a cost and time efficient manner. Nevertheless, PDMA requirements are very strict regarding data generated from clinical trials conducted outside of Japan on Japanese and non-Japanese subjects. The authors discuss the significance of early phase studies conducted outside Japan (particularly in the UK) and also outline some key areas to consider when selecting an organisation to help with conducting such studies.

Quality

What’s the Real Value of Audit? Results of the “QA: Friend or Foe” Survey

Jan Robinson MICR Csci

After more than 20 years in drug development Jan Robinson has experienced audit from a customer perspective in most of its guises. In this survey, she shares the thoughts and experiences of over 250 fellow professionals who have been involved in various types of audit, both as auditors and auditees, and presents some interesting conclusions on their effectiveness, timeliness and how they might be improved.

Professional development

Devices, Oncology & Beyond… ICR Freelance Forum

Rukhsana Shaikh-Zaidi FICR CSci

Rukhsana reports from the ICR Freelance Forum held late in 2010, which included presentations and discussions on a variety of topics, including medical devices, oncology and negotiating skills, along with regulatory updates and an innovative session, which enabled all delegates to share their ideas, favourite tools and business tips, before the group voted on which should be awarded the title “tip of the day”.

Viewpoint

Multinational Studies Need Multinational Professionals

Andrew Smith MICR

The proportion of industry studies taking place in a single country, with the exception of small early-phase studies, has decreased significantly over the past decade or more. However, multinational studies have more complex management structures and operate in more diverse environments of national regulation and oversight. An outcome of this is the evolution of a new generation of professionals with skill sets that didn’t exist 10 years ago. This is the age of the “multinational professional”. Andrew discusses this new set of skills, and a poll on the ICR website that suggests many members are already working extensively outside the country where they live. This item is also available as an audio podcast.

ICR update

Next Steps in ICR’s Development & Growth: Message from the CEO

Paul Wathall MICR

Writing almost a year ago, Paul Wathall alluded to the Institute’s need for a clear and focused strategy that capitalises on what we do well and remains true to our original mission, vision and values. Since then, we have implemented a balanced strategy, which, in addition to refocusing our attention on membership satisfaction, will modernise and drive improvement in our services more than ever before. As a result, over the next three years, members will benefit from many new and improved services. Paul discusses these in more detail, including our new flagship programmes, the Symposia and Masterclass events.

This is the Table of Contents of Clinical Research focus 22(3) for May 2011.

ICR members can download the entire issue [login required] using our eCRfocus service.

Cover story

Early Phase Japanese Bridging Studies: Global significance & CRO Selection Criteria

Keith Berelowitz & Jörg Taubel

In 1998, Japan’s PMDA, adopted the ICH “Guideline on Ethnic Factors in the Acceptability of Foreign Clinical Data”. This, coupled with the acceptance of the PDMA in 2007 of clinical data from non-Japanese patients, has helped to bring NCEs to the Japanese pharmaceutical market in both a cost and time efficient manner. Nevertheless, PDMA requirements are very strict regarding data generated from clinical trials conducted outside of Japan on Japanese and non-Japanese subjects. The authors discuss the significance of early phase studies conducted outside Japan (particularly in the UK) and also outline some key areas to consider when selecting an organisation to help with conducting such studies.

Quality

What’s the Real Value of Audit? Results of the “QA: Friend or Foe” Survey

Jan Robinson MICR Csci

After more than 20 years in drug development Jan Robinson has experienced audit from a customer perspective in most of its guises. In this survey, she shares the thoughts and experiences of over 250 fellow professionals who have been involved in various types of audit, both as auditors and auditees, and presents some interesting conclusions on their effectiveness, timeliness and how they might be improved.

Professional development

Devices, Oncology & Beyond… ICR Freelance Forum

Rukhsana Shaikh-Zaidi FICR CSci

Rukhsana reports from the ICR Freelance Forum held late in 2010, which included presentations and discussions on a variety of topics, including medical devices, oncology and negotiating skills, along with regulatory updates and an innovative session, which enabled all delegates to share their ideas, favourite tools and business tips, before the group voted on which should be awarded the title “tip of the day”.

Viewpoint

Multinational Studies Need Multinational Professionals

Andrew Smith MICR

The proportion of industry studies taking place in a single country, with the exception of small early-phase studies, has decreased significantly over the past decade or more. However, multinational studies have more complex management structures and operate in more diverse environments of national regulation and oversight. An outcome of this is the evolution of a new generation of professionals with skill sets that didn’t exist 10 years ago. This is the age of the “multinational professional”. Andrew discusses this new set of skills, and a poll on the ICR website that suggests many members are already working extensively outside the country where they live. This item is also available as an audio podcast.

ICR update

Next Steps in ICR’s Development & Growth: Message from the CEO

Paul Wathall MICR

Writing almost a year ago, Paul Wathall alluded to the Institute’s need for a clear and focused strategy that capitalises on what we do well and remains true to our original mission, vision and values. Since then, we have implemented a balanced strategy, which, in addition to refocusing our attention on membership satisfaction, will modernise and drive improvement in our services more than ever before. As a result, over the next three years, members will benefit from many new and improved services. Paul discusses these in more detail, including our new flagship programmes, the Symposia and Masterclass events.

NHS R&D Forum conference: Future of NIHR

The next session at the NHS R&D Forum Annual Conference was presented by Dr Jonathan Sheffield, Chief Executive of the National Institute for Health Research (NIHR) Clinical Research Networks, discussing the future of clinical research networks in the “new NHS”. He started by discussing the broader context around this: all Health Ministers in recent years have expressed their commitment to health research in the NHS and everything discussed at this conference has been about putting this commitment into practice.

He discussed the national and local initiatives to deliver and demonstrate performance improvements. Under the recent Growth Review, NOCRI was highlighted as the single point of contact for industry to interact with the NHS for research.

The strategic aim of the NIHR is to improve the health and wealth of the nation through research, to ensure the continuing strong performance of the UK life science industry. Jonathan summarised his goals as CEO of the NIHR as being:

• NHS engagement (particularly with patients, who by extension will influence physicians)
• Managing performance
• Working smarter and sharing best practice

Discussing the first point, Jonathan stressed the importance of using both top-down and bottom-up approaches. Working with the NHS Confederation, the Health Finance Managers Association (HFMA) and Medical Directors across Trusts, his clear message is that if you want your Trust to be at the top of its game, it needs to be active in research. Working with the HFMA, the goal is to make research finance and funding simpler, so they can better appreciate the importance of research to Trust finance. His one gap at the moment is nursing managers, and he is looking to engage with leaders in the nursing profession to better facilitate research skills in nurses’ careers.

However, this top-down approach must be complemented with a bottom-up approach, with all NHS research staff acting as Ambassadors for research within their Trusts and amongst their peers.

Moving to performance management, Dr Sheffield felt that we don’t currently provide the most appropriate training and tools to deliver high performance in clinical trials. He compared this with the success of process management tools in managing, eg, hip replacement waiting lists. Networks will report to the single Coordinating Centre and will report on clear targets of time and performance. Similarly the networks will manage Trusts according to the same metrics. By increasing transparency around these metrics, he expects competitiveness between neighbouring Trusts to drive improvements in performance.

Dr Sheffield discussed high levels performance metrics that he is directly involved with: percentage of Trusts participating in Portfolio studies, the number of participants in Portfolio studies, increasing the percentage of commercial life sciences studies delivered, reducing the time taken to recruit first participants into studies and to reduce time taken to achieve NHS permission through CSP. Other core objectives exist around professional/workforce development across networks.

However, improvements can only be delivered by working smarter. This can be delivered by establishing Lean Research capability, training existing research staff in Lean methodologies used in, eg, the cancer collaboratives and in other industry sectors. These will be driven by shop-floor activities and promoted by making these activities and metrics much more visible, both in individual R&D departments and throughout the Trusts.

Jonathan gave the example of Toyota cars, who improved the design to production timeline from 9 years to 9 months. He believes the comparable improvements in performance could be delivered, but only if we work together.

He took to task the preconception that formal “due diligence” is required on all contracts (under MONITOR) – in fact, this is only required for activities covering more than 10% of a Trust’s turnover… whereas even the largest research-active Trusts currently achieve around 3%. Similarly, risk management should not be so heavily prioritsed, as payments for damages relating to research are only around 0.002% of the total damages paid. These factors indicate that R&D managers should change from being “governance managers” to “process managers” to deliver performance for the Trust, as the commercial and liability risks are relatively negligible compared to other aspects of Trust activities.

So, R&D Managers should focus on delivery. When promoting research throughout an organisation, the focus should be on the benefits (to broader patient care, engagement etc. as well as financial) rather than the risks and potential downsides. Similarly, staff working flexibly on research will also be able to apply this increased flexibility and general performance improvement skills to other areas of Trust activity.

To summarise, Jonathan stated that the future of the networks is:

• Local accountability and autonomy
• Rapid progress
• Support for commercial and non-commercial studies
• Risk-based management
• Visibility and transparency of performance

In the Q&A session, Jonathan stressed that he feels Trusts should not front-load their charges for commercial research, as commercial sponsors are output-driven and would be much more inclined to reward high-level outputs.

Regrettably, travel arrangements mean that I will be unable to report on the final plenary session of the day, in which Marc Taylor of the Department of Health will discuss the Research Support Services (RSS) Framework, which has been in place for several months in draft form, but is expected to be officially launched very shortly. I hope to summarise his presentation after the conference.

NHS R&D Forum conference: Academy of Medical Sciences review

The second plenary session at the NHS R&D Forum annual conference was a joint presentation by Prof. Sir Michael Rawlins and Robert Frost of the Academy of Medical Sciences on the outcomes and next steps of implementation of the AMS’ review of regulation and governance in clinical research, which was published earlier this year.

Prof. Rawlins stressed the UK’s proud history in the development of translation medicine, the theoretical basis of clinical research and epidemiology, and thereby many of the significant developments in medicine. Clinical research is vitally important to patients, the public, clinical scientists and also to the life sciences industry and “UK plc”, as the industry indirectly employs around 250,000 people in the UK.

He divided the current regulatory and governance arrangements in the UK into 3 groups: clinical trial authorisation (implementing the EU Clinical Trials Directive), ethics approval(s) and NHS governance arrangements. He noted that while the Directive is around 10 pages long, its implementing text is more than 10 times that length! While many of the provisions of the Directive for genuinely investigational drugs are justified, their application to licensed drugs being studied in their licensed indication can necessitate full GCP compliance, monitoring, indemnity etc. which can make studies non-viable.

He then listed the various ethical approval steps that could be needed for particular types of study (which often run in series rather than in parallel) and the (many!) “global” and “local” checks required by NHS governance.

Prof. Rawlins then handed over to Robert Frost of the AMS, who discussed the study itself and how it was conducted. Calls for evidence were requested in 2010, and over 300 submissions were received from across a broad range of stakeholders. The report was published in January 2011.

The study identified bottlenecks in a number of areas:

1. A healthcare culture that fails to fully support the value and benefits of health research
2. Inappropriate constraints on access to patient data
3. A lack of proportionality in the application of the EU Clinical Trials Directive
4. Delays and complexity in NHS R&D Permission

Culturally, they found that patients’ support for research was conditional on ongoing engagement, but also that NHS staff were often risk-averse, with a cultural change needed to embed research amongst staff and in NHS processes. Robert felt that this could be due to the complexity of the process, leading to uncertainty of the process and trying to adopt a “one-size-fits-all” approach to governance to avoid this.

Access to patient data is governed by a complex network of legal requirements (EU, UK, professional etc.) with numerous sources of guidance and no clear mechanism to identify patients to participate in research. This leads to duplication of checked, inconsistency and confusion. Evidence was also given of an “adversarial” approach which as taken in some clinical study inspections.

Overall, the study group identified the need to simplify and streamline the multiple layers of review and bureaucracy around authorising clinical trials, to reduce uncertainty and inconsistency.

Robert handed back to Prof. Rawlins to discuss the study’s recommendations. These have been discussed in detail in the February 2011 issue of Clinical Research focus, and in an audio interview with Prof. Rawlins available via the CRfocus website.

The session concluded with Q&A… One delegate asked how the risk-aversion of the NHS should be addressed. Prof. Rawlins suggested that investigators should take the lead in this. Another delegate asked about reforms to data protection legislation; Prof. Rawlins said that this is a complex area. The UK legislation is not strictly compliant with the EU Data Protection Directive, but is also inconsistency applied by many government department. This whole area needs much deeper investigation.

A final question asked about the place of the report’s recommendations amongst the other initiatives that already going on to reform approvals and governance within the NHS, and whether we should wait to see their impact before beginning another wave of radical change. Robert Frost answered that they had been aware of these other streams of activity, and a later session in the conference would explain how the two areas will continue to interact.

NHS R&D Forum conference: Patient involvement

This year’s NHS R&D Forum Annual Conference, which began today in Bristol, is titled “Proportional and Pragmatic Review”.

The keynote presentation was delivered by Neil Formstone, who is a patient representative and advocate, reminding delegates of why we are all so committed to working in clinical research. Neil began his role following a battle with cancer around 15 years ago, and is part of a network of patients and professionals  who train on research skills and, most importantly, serve as a constructive and pro-research voice both within and on behalf of research teams. His particular areas of interest are biobanking and clinical research.

His starting point was that the general public have very little idea of the scope of NHS research and the importance of research professionals in driving the NHS forward. He commented that most public involvement is as a “recipient” rather than a “participant”, and his aim is to transform research into something that is done “with” patients rather than “to” them, based on a real understanding on how research actually works in practice. Although involvement has improved, it is still generally nowhere near an equal partnership, with patients involved at the earliest, most formative level of designing a research project.

Neil examined the common arguments against higher levels of involvement, based on the misconception that patients have little to offer and would generally only complain. Conversely, patients bring invaluable experience or understanding of the process being research, and an alternate view of how it may affect people and ways to improve the outcome. They often do have the sills, but they often only realise this if they are asked the right questions in the right way… which is often not the case. So, asking questions in a way that patients can understand and respond to will often have surprisingly positive results.

Neil gave a case study on patient involvement in the Welsh Cancer Bank. Patients served as advisors helping to consider how to communicate the Bank’s key messages to the wider public, advocates and lobbyists as well as donating samples to the bank. Patients were strong advocates for, and information sources about, the bank and its aims, and were very successful in helping to bring additional patients to contribute to the bank and be more broadly involved. Patients were full members of the founding Steering Group in 2002 and a Patient Liaison group was formed in 2003 to co-develop consent forms, MREC submissions, protocols etc. 42% of attendees a the organisation’s launch were patients. Neil stressed the role in lobbying politicians in these difficult financial times, where patients, as voters, can be particularly effective in protecting funding streams from government.

Among the lessons learned at the Welsh Cancer Bank are that other health professionals should be brought into more direct interaction with patients, particularly those who work away from the ward. They gain the chance to learn directly from patient experience, which can improve sample collection, handling and analysis processes. Most scientists are surprised at how much for a benefit true involvement brings.

However, Neil also stressed that patients who do not contribute constructively to a project should be removed from the group.

Neil then pointed delegates to the clinical research route map found on via Association of Medical Research Charities (AMRC) website, which expands the research process to give additional details on each step.

After giving a quick plug for another session he’s leading later in the conference, he summed up his aim as to get rid of the patient as a guinea pig and bring their insights and experiences more into the research process.

In the Q&A session, one delegate suggested that the ethics committee process being over-protective of the information given to the general population. Neil agreed, and stressed that adult patients should be treated as adults and given information fully, without “punches pulled”. He felt that this is tantamount to insulting the general public, but that the fight would continue for a while.

Another delegate expressed concerns that any patient advocate could give a biased perspective based on their own experiences rather than the wider group of patients. While Neil agreed that no individual can completely represent the entire population, but suggested that working in teams of patients can produce a broader view, which is then communicated back to the research team via the advocate.

Following an Example… & Setting One

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”. In the UK, the Academy of Medical Sciences is currently considering recommendations on how the regulation and governance of UK medical research should be revised (www.acmedsci.ac.uk/p47prid80.html). Meanwhile, the European Commission has driven a number of studies and consultations into what might reinterpret, revise or replace the current patchwork of Directives and guidance built around Directive 2001/20 (http://ec.europa.eu/governance/impact/planned_ia/docs/47_sanco_clinical_trials_directive_en.pdf). Something must be done, and it will be done… eventually. But, while the wheels of political and regulatory change grind slowly onwards, what do the rest of us do for now?

Those of you who attended the ICR Annual Conference a few months ago, the ICR Patient Recruitment Forum in May, or several other meetings on the UK ‘conference circuit’ over the past few months will have heard about the North-West Exemplar project (www.ukcrn.org.uk/index/industry/nwexemplar.html), which is expected to announce its results in the next few weeks. At its simplest, the project has looked to drive the current systems for NIHR Portfolio adoption, site feasibility/selection and R&D permission as effectively as possible, through an energetic and focused team to facilitate communication, with access to the higher echelons of NHS Trusts and industry if that’s what it takes to make things happen. Although formal results have not yet been announced, interim results presented at conferences have been very encouraging.

At a pan-European level, the Clinical Trial Facilitation Group (CTFG, comprising members of the Heads of Medical Agencies, www.hma.eu/78.html) has been piloting a Voluntary Harmonisation Procedure (VHP) for the past 18 months, looking to produce more consistent outcomes for regulatory review of multination studies, while also making more efficient use of resources at national regulators. Again, while the system is not without its critics, results have generally been positive.

Both of these initiatives have improved on general current performance, with a basically ‘bottom up’ approach to working vigorously with what we have. My point is not that ‘bottom up’ approaches are innately better than ‘top down’ ones, because each of these examples have only succeeded by using the tools and structures put in place as a result of ‘top down’ thinking. However, any ‘top down’ strategy can only be as successful as its implementation, and actually implementing anything is really about work from the bottom up, and having the passion and energy to use whatever’s available to achieve the desired result.

This is the success of projects like the NW Exemplar and the CTFG VHP, demonstrating the results that can be achieved by working constructively with what we’ve already got. But this is also their failure: highlighting that potentially useful tools are often not used effectively (while perhaps weakening the argument for any more radical change). What matters most appears to be the energy, enthusiasm and commitment of the people operating the system. With the right people in all the right positions, performance could be improved far more quickly than any legislative solution could achieve. However, the degree of cultural shift required to spread these improvements widely is notoriously hard to achieve in any large organisation, particularly one with as much character as the NHS.

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.

This could have as much impact as the legislative change we’re all calling for. And you and I can each start doing it today…

Blogging from EFGCP conference on personalised medicine

On January 26th and 27th I will be blogging from the EFGCP Annual Conference, which this year has the theme “Aspects of Personalised Medicine for Society – a Challenge Yet to be Met”. From the main page about the conference:

For the past 50 years the development of new medicines has been highly successful. As a result, many diseases have been well treated – sometimes cured or at least their symptoms relieved. Success could be measured by the number of patients thus treated. However, such success had to be leavened by the frequency of side effects and it had to be recognised that potential success for an individual patient could be nullified by the unacceptability of such side effects. So attempts were made both to increase the efficacy of new medicines and to improve their tolerability; and, in parallel, it was realised that efficacy and tolerability of any given medicine varied between individual patients. The traditional tools for finding the right dose for most patients were randomized controlled clinical trials and post-marketing surveillance studies; but, recently, the recognition that the individual genetic profiles of patients could be identified in terms of their susceptibility to treatment with medicines as well as their susceptibility to the side effects of such medicines has enabled a paradigm shift towards the success of a new medicine. Knowledge about the individual genome has clearly opened up huge scientific opportunities, but accompanied by a significant need to identify, discuss and attempt to solve aspects of personalized medicine related to society as a whole. This conference will tackle the complex issues involved, including the ethics of providing confidential information arising from knowledge of the individual genome, associated economic factors, access to tailor-made treatment and how this should be prioritised. By means of a series of presentations by those experienced in handling these issues, and six interactive workshops, the EFGCP Annual Conference 2010 will aim to identify the challenges of personalized medicine in the context of society as a whole yet to be met. The various roles of all the stakeholders, from the bench-based scientist to the patient, will all be discussed in the interests of identifying the best possible treatments for the society of the future.

Further information about the conference, including how to register, can be found here. I will be posting almost-live from the conference to this site, and will also publish a more formal report in a future issue of Clinical Research focus (hopefully the March issue).

Panel discussion

The day’s speakers were joined for a final panel discussion by Dr David Collier of QMUL, Janette Benaddi of ICR and John Hladkiwskyj of the CCRA. Maxine Robertson highlighted four key questions to frame the debate:
* What might affect positive change in the system?
* How might we achieve a coordinated approach to affecting systemic change?
* Are there any short term fixes?
* Which stakeholder within the system is best placed to drive particular changes and how might these stakeholders go about this?

David Collier likened the future of clinical research in the UK to the manufacturing industries of decades ago, where we have been unable to compete on unit cost, but have become much smarter in terms of designing and marketing products. John Gribben agreed with this, and suggested that the UK being seen as smarter is the main reason that pharma has not yet left the UK in the face of rising development costs and declining revenues.

Janette Benaddi welcomed the results of the study as reaffirming the UK’s position, what we do well and also the problems that we face. We are doing much to address these, and the results are beginning to be seen. Addressing the need for a coordinated approach to change, she commented that meetings are often rather one-sided.

One delegate commented that the survey results put into formal numbers things that had been known anecdotally for several years. He called for even more sophisticated analysis to pinpoint areas for future improvement. He also called for more involvement of patients. John Gribben agreed with this, but commented that in his experience lay members of ethics committees have been some of the most difficult to deal with.

John Hladkiwsyj also commended the results, and added that we need to more actively promote research sites to CROs and sponsor, providing a more welcoming attitude. Maxine suggested that this might also be due to the shortage of personnel and motivation. John Gribben highlighted that research nurses face the lack of career path most acutely. One delegate stated that she had just appointed a lead research nurse to develop the role, and called for more experienced research nurses to have hybrid roles between research other senior nurse clinician positions.

Another delegate discussed the perceived problems and delays with R&D departments and questioned whether they received adequate funding. John Gribben said that they are generally expected to be self-financing with no funding from the wider Trust. This cut-off perhaps stems from practices some time ago when R&D funds were routinely siphoned off to underpin other Trust finances.