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. This year we invited contributions from over fifty people from all sectors of the clinical research community. Here is a selection of the most interesting responses, to give you some more insight into what to expect next year, and into the future. We thank everyone who took part for their efforts, and hope that some, if not all, of them will see their predictions come true.
The end of the age of the RCT?
Les Rose FICR (Independent clinical research consultant)
It seems possible that we might be in for a confusing time. On the one hand, the regulators will continue to expect very standard approaches to trial design, and indeed will (to some extent) dictate what studies we do. On the other, the role of the randomised controlled trial is being challenged, not only by the anti-science community but by eminent individuals. Sir Michael Rawlins famously stated last year that the “gold standard” position of the RCT was unjustified, and that a more inclusive approach to evidence was needed. Clinical research professionals must not ignore this conflict, and must engage in the debate.
As I write, the consultation on the EU Directives remains open. It would be over-optimistic to expect responses to it to be analysed and interpreted in any practical way by the end of 2010. The paradox of aiming for genuinely common standards while avoiding excessive bureaucracy will no doubt remain in place. Even if, miraculously, some changes to the Directives were to be effected, compliance is another matter, especially on the part of ethics committees composed of unpaid volunteers with minds of their own. It is to be hoped that the protestations of academics are not over-interpreted, and that a double standard is not allowed to emerge.
In the UK, it surely is time that political control of the NHS is relaxed. More focus on health outcomes is needed, and less on gerrymandering statistics for political ends. The UK's performance in clinical trials is dire, and rapidly getting worse, despite various government initiatives. I don't expect this to reverse in 2010, but it would be nice to see the deterioration slowing down.
Treatments, markets & CRO evolution
Nicky Dodsworth MICR CSci (Senior Director, Global Quality Assurance, Premier Research Group Ltd)
Treatments
With the enlarging elderly population, there will be more chronic conditions, increasing the strain on healthcare systems. How can we transform the greatest number of lives? The answer, I am sure, lies with developing cost-effective treatments for conditions such as Alzheimer’s disease and other similar conditions.
Also we need to consider the rise in obesity levels and related treatments. Personalised healthcare is still in its infancy; in years to come this will become a reality.
Markets
The immediate future will continue to see accelerated expansion in the new emerging markets, such as India, China and South Korea. However, in the long-term, this may not be sustained, and clinical research will improve in the more traditional markets.
CROs
How we (CROs) deliver high-class services to meet our customer’s aspirations will continue to remain important. CROs will be required to be even more flexible as more innovative treatments emerge. Diversity is going to be vital for our industry.
Society's low opinion of the pharmaceutical industry
Nigel Crossland (Independent pharmaceutical scientist & consultant)
This is caused by general poor understanding and thus suspicion of all science based activities brought about by anti-science educational programmes, adverse publicity generated by the news media and uncaring government ministers who either don't understand present-day drug R&D, or its significant contribution to healthcare within the NHS and to the also very significant benefit to the nation's wealth. Also a factor is the belief that the drug industry is profiting from the NHS and “bleeding it dry” when in fact the total drugs bill has never been greater than 12% of the total NHS bill in recent years.
This could all change in 2010 due to a series of programmes sponsored by the ABPI which through books, pamphlets and TV educational events help to turn society's attitude to one of appreciation and gratitude. The programme will be both ambitious as well as novel and will entail the employment of patients and doctors who are seeing the benefit of well designed drugs in alleviating their personal and professional health problems.
Is this just wishful thinking? Well, if we continue along the path that we have all been following, then we are closing the door to the movement of the best brains into the exciting and morally justified world of drug discovery. As for government antipathy, perhaps we just need a better set of people in charge…
Reinventing data handling
James DeSanti (CEO, PharmaVigilant)
With the advent of the recession, there’s been much speculation about the transformation of the biopharmaceutical industry, and how companies are responding to the increased pressure to cut costs and streamline operations. While there has been a recent spate of mega-mergers and consolidation, the fundamental intentions of the industry hasn’t really changed: companies still need to bring new drugs to market. Although speciality drugs will garner a great deal of attention, new drug development needs to continue across all therapeutic areas. Re-structuring can lead to cost efficiencies and reduced overhead, but true innovation and change still comes about through research and drug development.
As a result, R&D departments are under growing scrutiny to increase efficiencies: gone are the days where bloated trial costs are the norm rather than the exception. As R&D continues to come under the microscope, pharma execs are counting on their technology partnerships to help them increase their productivity and reign in gross inefficiencies and soaring expenses. Unfortunately, however, they’re realizing many of the systems currently in place have antiquated models and an overhaul is needed to achieve real innovation and change. This requires a forward-thinking strategy and a sound deployment plan.
Keeping that in mind, one of the biggest industry trends I anticipate in the future is a greater emphasis from sponsors on the control and access of their clinical trial data. Rather than relying on their technology vendors to retrieve their data in a timely (and often not-so-timely) manner, sponsors instead want it at their own fingertips. And rather than a standardized reporting function, they want their technology partners to offer creative and flexible collection and reporting solutions. A one-size-fits-all model doesn’t work for an industry full of diverse and unique businesses. No two pharma companies are the same, and sponsors need technology solutions that can adapt to different scenarios and provide customized options. As the general public, not to mention the FDA, demands safer drugs and larger trials to support the efficacy and safety profiles, the current model does not scale: traditional approaches to clinical development utilizing time and material models no longer work.
Another change I see coming in the future is a shift in the way sponsors and sites interact. There is huge opportunity to cut costs at the site level, improve site satisfaction, and improve the quality of the clinical data, particularly on the monitoring side. This is not only appealing to sponsors from a cost perspective, but also to the sites themselves: the less site disruption, the happier the site.
Taking the lead in paediatrics
Jane Lamprill FICR (Paediatric research consultant)
It was only a thousand years ago that the Bourne End area was being swept by Viking raids and in 1010 that Buckinghamshire was first recognized as a County. This was probably recorded by some charter or other on parchment. Fortunately, in 2010 there are now smart ICR offices with helpful staff using more modern means of communication to inform, educate and assist those of us still working in pharma.
What of the next thousand years? World events are moving so fast that nobody can say what will happen next week let alone next year! We have all experienced the nasty bite of the credit crunch and pharma-land is rife with redundancies. As there are now fewer staff performing the same workload, there are fewer hours to meet critical recruitment deadlines in an increasingly competitive environment.
This is especially true when paediatric data is required for legally-required paediatric investigation plans (PIPs), without which the SPC extension reward cannot be claimed against the ticking clock of patent expiry. I therefore suggest that the companies who will be ahead of their competitors in 2010 will be those who:
- Are well organized and paediatric focused from the top down
- Have a ‘joined up’ in-house paediatric strategy, especially between regulatory and clinical departments
- Give their staff plenty of ring-fenced time for eg, planning child-friendly studies and writing age-appropriate information sheets
A special message for companies who plan to register their drugs in Europe and seek rapid recruitment in countries where healthcare is not free at the point of delivery: be aware that in 2010 the European Commission will be increasing the level of audit and inspections in these 3rd countries, with particular reference to quality of data and good ethical conduct.
So, 2010 will see challenges ahead which will require ‘out-of-the-box thinking’, ethical vigilance, constant training and updating… let alone keeping up with the day job. But, at least the Vikings have gone!
The Tories are a-coming!
Alan Jones (Independent analyst & commentator)
It is now only a few months until the next General Election when a Conservative government will likely emerge. By then we will have had some 13 years of Labour healthcare reform and before that 18 years of Tory health policy. So, folk in the industry will no doubt be wondering how (if at all) things might be different under a new government. Tory plans are a bit sketchy at the moment but essentially it’s all about abolishing targets, growing the mixed ‘market’ of the NHS, public health reform, ending ‘ministerial meddling’ by creating an independent NHS Board, attacking the ‘army of bureaucrats’ and giving more commissioning power to GPs… all actually a bit ‘back to the future’! All parties in opposition say things that they regret when they come into power, so how ‘true’ these hints at Tory health policy will turn out to be remains to be seen. But, as Labour has built on previous Tory reforms, expect the Tories to build on those of Labour and further expect, in England at least, that the same general direction of reform will be travelled.
But what is so very different this time around, of course, is the worst recession in living memory and an arctic winter fast approaching the NHS. A brand new driver for 2010, then, will be all about how to meet the increasing demand for healthcare with less money. Andrew Lansley, Shadow Health Secretary, has laid out plans to cut the level of NHS bureaucracy by a third from £4.5bn to £3bn a year by 2013-14. He slammed Labour for a wasted opportunity to deliver real improvements to the health service over the years, which has seen nine reorganisations, costing £3bn. In addition, he stresses, there are now 80% more managers and yet productivity is down 4%. Accusing Labour of allowing wasteful spending on bureaucracy to get out of control, he promised that a Conservative government would deliver leaner, good-quality management and a shift of funds back to the front line. But management cuts are unlikely to go anywhere near funding the quoted £20bn savings, and many say Tory health plans are a bit confused… Note also that Mr. Lansley has also said that he could not guarantee a Conservative government would stick to the NHS allocations for 2010/11 and he wants all NHS organisations to review their budgets on a zero growth basis, going back to each area of spending and scrutinising where it fits with NHS priorities and cost effectiveness. He also wants the public take more responsibility for the lifestyle choices that they take, as unchanged this will create unsustainable demands on the NHS.
As both parties now engage in pre-election banter about cuts or no cuts, the countdown to the General Election (possibly on May 6th 2010) certainly seems to have begun. Although the Tories are using exactly the same mantras going forward as Labour vis-à-vis higher productivity, efficiency and quality being needed, expect the high rhetoric to continue.
In a nutshell, then, expect more of the same, but with a slightly smaller NHS and even less money to play with.
Increasing importance of infusion delivery
Elena Skryabina (Manager of Evaluation Laboratory, Bath Institute of Medical Engineering)
Intra-venous (IV) drugs play an important role in modern healthcare. In the UK alone, over 15 million infusions are carried out in the NHS every year, with around 90% of hospitalised patients receiving IV medication.
1
Most of the hospital-based IV deliveries are conducted via an infusion pump, which makes it an essential tool in modern healthcare. In the past decade, an increase has also been observed in the number of drugs delivered via infusion pumps in home-care settings,
2
and the market is expected to grow, particularly in the context of the aging population.
In order to ensure safe drug delivery via an infusion pump, clinicians must not only rely on safe and accurate pump performance, which must be provided by the pump manufacturer, but must also make sure that an IV drug is compatible with the fluid contacting parts of the entire delivery system, is stable under the relevant clinical conditions and for the required period of delivery, and have a therapeutics index long enough to be delivered by a pump. Further clinical research may be required to facilitate a specific drug delivery regime, eg, the ambulatory administration of unstable drugs in home settings, which is particularly relevant for cancer and palliative care patients. Some disposable pumps, which are widely used for ambulatory drug deliveries, are made from materials not typically used for fluid containers and administration lines of general ward-pumps. Users must, therefore, not assume that drug stability and compatibility data for commonly-used medical materials, such as PVC and polypropylene, will be applicable to disposable pumps.
3
Further research will, therefore, be necessary to provide separate data on the drug stability and compatibility with the fluid container and fluid-contacting parts of the disposable pump.
The provision of safe infusion pumps plays an increasingly important role in the future of drug-related clinical research. Familiarity with clinical environment and therapy requirements, as well as understanding of the characteristics and requirements of devices is necessary for its successful outcome.
Halcyon days? Long gone!
Ann Maloney HonFICR (Managing Director, CSL Recruitment & Consulting Ltd)
We face continuing readjustment for at least another 12 months, as industry realigns portfolios and mergers continue to gain momentum to improve shareholder value in the new world of accountancy driven decision making.
No day goes by now without phone calls from candidates concerned about jobs in Clinical R&D in the UK. As we reflect on 2009 at CSL we thank our lucky stars that we have been fortunate to have a steady, if evolving, flow of jobs despite the recessionary forces. Unfortunately, we have to admit we are still witnessing a steady decline in UK-based roles as companies merge, as new funding for riskier R&D remains restricted and as clinical research jobs move overseas where conditions for clinical study delivery seem optimal. The insight provided into some of the issues the UK faces at the recent ICR Ethics/GCP Forum did not reassure me that, despite impressive performance metrics in some quarters, we are addressing the industry concerns fast enough to convince companies that the UK remains a location to achieve results.
What does this mean for us all?
“The Halcyon days have gone,” one UK Head of Clinical Research said to me this week in passing. Consensus is now amongst our employers, candidates and other agencies that we have difficult times ahead as companies merge and global access to patients and trial expertise increases around the developing world. Obtaining a diverse skill set and gaining experience within differing organisations (big vs emerging pharma, CROs, biotech) is more critical to career success. Many candidates are currently in an employers' market and whilst opportunities still exist, competition is now very tough. You may find you have to return to the NHS, work in the public sector or move from home to maintain continuity of work.
To be certain of finding a role you must be active in presenting yourself well to the agencies who work with the clients who appeal to you. Note that by the time the role is in the public domain, the agency may be well through the selection for their best 3 candidates. If you are unemployed, review your options and try to meet face-to-face with agencies in your own time to build understanding and seek their help in focusing your search on the clients they represent. If you can move or weekly commute do so rather than joining the unemployed; this simply makes it harder to find a job. If you are in employment:
- Stand out as a contributor and avoid unnecessary sickness absence; this is under closer scrutiny in referencing
- Be content if you don't get a pay rise; aim to negotiate bonus instead for good contribution
- Build your presence through networking and visible contribution
- Summate your achievements, testimonials and cumulative experience as you go, so you have it handy
- Access wider expertise and training whilst you can
This contribution is summarised from a full-length article, which is available via the CRfocus website (www.crfocus.org) and direct from Ann’s website (
www.cslrecruitment.com/jobseekers/resources/Default.aspx?cid=105).
Reinvigorating vendor/customer relationship management
Andrew Parrett (Chair of Pharmaceutical Contract Management Group (PCMG))
We have some big challenges to face over the next five years in clinical development outsourcing. Across the industry, there is a drive for more ‘preferred provider’ arrangements between sponsor and vendor companies, but there is no reliable empirical data to show that such arrangements are achieving the tangible benefits that many sponsor company stakeholders would claim. The agenda is too often being set by purchasers emphasising point-of-transaction metrics to suggest savings that cast individuals in a positive light, but say nothing about the real cost of projects. It may not quite be another Enron waiting to happen, but it does represent a problem in financial management that pharma needs to address. Perhaps such arrangements are realising savings... perhaps they are not. My suspicion is that they are in some cases, but not in others and the challenge is for pharma to find accurate and consistent ways to measure so that we can make informed decisions in advance of our outsourcing strategies.
Whatever the uncertain costs or savings of preferred provider relationships, we also need to work harder on their delivery. At present, there is a lot of goodwill, which is commendable, but not much obvious practical consideration of what it really means to work on a relationship with your preferred provider. Governance is a conference theme that has been repeated ad infinitum, demonstrating a persistent lack of creative thought in the development of the vendor manager role. For me, the focus is all wrong. We should not be thinking about ‘preferred provider’, but rather ‘preferred customer’ arrangements. Maximising the potential for successful project delivery through relationship management means sponsor companies taking responsibility for motivating vendor stakeholders. It means prevention of conflict (not cure) and some progress in implementing mechanisms to achieve that (not the relentless rediscovery of issue escalation policies) is where I would hope to see a shift in emphasis for clinical development outsourcing practices through to 2015.
Concluding thoughts
In addition to the wide variety of topics and opinions presented here, there are two significant questions hanging over the future of European clinical research, and they are closely linked. As I write this piece, as close to our print deadline as possible, the big news is the proposal of the European Commission President to move the pharmaceutical policy brief from DG Enterprise (covering industry and innovation issues) to DG Sanco (covering health and consumer issues). While unlikely to have any immediate impact on our working lives, if approved by the European Parliament in January, it would have a significant influence on the context for the other big question: the potential revision (or replacement) of the Clinical Trials Directive.
The Pharmaceuticals Unit, currently within DG Enterprise, is starting to move on this topic (which has been the subject of heated debate since the original Directive came into force in 2004) and a consultation is currently underway, aiming to identify the key areas for revision and preferred approaches to change. This is the start (or, at least, near the start) of a long process, so any final drafting would take place with the team under the guidance of the Health Commissioner, so some in industry might be fearful of what additional measures might be included (eg, more stringent safety standards, governance and transparency etc.) and what incentives for innovation and streamlining processes might not be given such attention.
At this time, the above thoughts are several degrees of speculation, but this is an important topic and one which we will continue to cover in CRfocus as it evolves.
The other issue facing the UK, and indeed western Europe as a whole, is the increasing globalisation of pharmaceuticals and its changing (declining?) attractiveness as a location for clinical trials and, ultimately, as a market for medicines.
I wrote about this in detail in October’s issue of CRfocus,4
and will not reiterate the issue too much here, but professionals in these countries should prepare for continuing change in the quantity, scale and type of studies that they work on. While managers with an international remit might remain involved with managing the non-US portions of large late phase studies and providing guidance to less experienced colleagues and sites in India, China etc., those working at a national level will be more likely to be involved with small, exploratory studies or post-marketing type studies (even if conducted prior to registration) to demonstrate the applicability of global data produced in other regions to the local healthcare setting and socio-economic context. To some, this increased connection of their work to a medicine’s local usage and impact might make up for the likely decrease in the total volume of research being carried out in the more expensive, developed countries.
Re-reading the whole of this piece before sending it to print, it comes across as being quite pessimistic. It’s important to retain some optimism about what we do and why we do it, and worthwhile reflecting that our industry has been less affected by the recession than many other sectors. The turbulence we have seen is as much about preparing for the next strategic shift in healthcare, where blockbusters will be less important, prescribing will be more personalised, the value of interventions will be more closely linked to actual patient outcomes and research will be more sophisticated in the questions it asks and how it goes about answering them. The eventual result will be products that match better with patient needs and a development process that’s clearer about where value is added. In short, where we are going is much better than where we’ve come from, even if it’s proving painful to get there.
However many of these predictions, hopes and fears actually come true, one thing that we can all be sure of is that 2010 will be another interesting year. I look forward to watching it all unfold, and reporting on it for you here in the pages of Clinical Research focus. Finally, I would like to take this opportunity, on behalf of all of us on the CRfocus Editorial Advisory Board, and in the Institute office, to wish you a Merry Christmas and a happy, and productive, New Year.
- Quinn C, Stevenson E and Glenister H. NPSA infusion device toolkit: a cost-saving way to improve patient safety. Clinical Governance 2004, 9 (3): 195-199.
- Negro S, Azuara ML, Sanchez Y, et al. Physical compatibility and in vivo evaluation of drug mixtures for subcutaneous infusion to cancer patients in palliative care. Support Care Cancer (2002), 10, 65-70.
- Skryabina EA, Dunn TS. Disposable infusion pumps. Am J Health-System Pharmacy (2006), vol 63, 1260-1268.
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Smith A. Multinational Trials: A New Balance Point? CRfocus (2009), 20(10) p7-10.
