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Inside Out

The Pharmaceutical Contract Management Group (PCMG) annual conference is unusual, if not unique, in Europe. Firstly, it is not a commercial venture like so many of the conferences on the pharma calendar. Secondly, it does not have an associated exhibition, but is made affordable by having multiple sponsors. Thirdly, and perhaps most The Pharmaceutical Contract Management Group (PCMG) annual conference is unusual, if not unique, in Europe. Firstly, it is not a commercial venture like so many importantly, it attempts to balance the pharma representation against service providers, in a ratio of about 2 to 1. At this point, I should confess a vested interest – I was a member of the organising committee – but it is truly interesting and enjoyable to attend: there is a light-heartedness about it that is lacking at many other events.

Its 2015 conference, held in Warsaw, Poland on 10-12 June, was themed ‘Risk, complexity and compliance’ – topics dear to the heart of contract managers – with presentations drawn from industry, CROs and, notably, project practitioners and academics from outside the industry. There was also a running theme, entitled ‘Room 101’ – a reference to both the torture room in Orwell’s novel, Nineteen Eighty-Four, which reputedly contained “the worst thing in the world”, and to a BBC TV comedy series in which celebrities discuss their pet hates. Another highlight was an ‘Oxfordstyle debate’ on the extent to which procurement has dented sponsor-CRO relations and the conduct of clinical trials. Much then, for the 200 or so delegates to consider.

Annual Report

Kicking off proceedings, PCMG Chairman, Richard Scaife from Mitsubishi, and Vice Chairman, Lan Bandara of Eisai, offered a review of the year. They noted that 2014/15 had seen some pharma acquisitions, as well as some near-misses (notably Pfizer’s failed takeover bid of AstraZeneca), further pharma rationalisation and continued CRO growth. In addition, PCMG’s initiatives for improving the management of outsourcing were outlined, and a variety of templates (available to members only) were recommended:
  • CRO scope of work and budget grid
  • CRO selection scorecard
  • Relationship management plan
  • Lessons learned template
  • CRO performance metrics
Moreover, the speakers explained that the PCMG foundation course has been completely rewritten to reflect current best practices in outsourcing.

Quantified Risk

Risk-based approaches were a feature on the first day, with Stephen Nabarro and Charlotte Allcock from Cancer Research UK exploring risk vs reward in early-phase oncology trials. Their approach – given a green light by regulators – yielded significant benefits, including decreased electronic case report form (eCRF) completion plus query resolution time, and a reduction in monitoring visit frequency.

Eyeing the future, the presenters said they will strive for more real-time risk assessment on projects; adopt a more risk-adjusted approach to protocol design; examine the potential to reduce the level of source data verification on critical data; and develop the potential to share risk scores and criteria with investigative sites.

The use of risk-based approaches in small, early-phase studies is clear, but Julianne Hull of Wenstar Enterprises and Medidata’s Richard Young highlighted that they have also been successfully applied in large Phase 3 studies. The speakers set out research looking at 90 trials and compared them with over 4,000 studies where risk-based monitoring (RBM) was not applied – assessing query rates, data correction rates, site performance metrics, cycle times and eCRF design metrics – to understand the value of RBM.

Research found that clinical data quality was maintained, site monitoring interactions have changed, as well as evidence that the players’ behaviours are evolving – so perhaps greater, quantified risk is the way forward. The point made was that RBM is not a cost-reducing exercise, but some cost reduction could be an associated benefit.

CRO Perspective

Clara Heering, ICON’s Vice President of Clinical Risk Management, contemplated the issue of RBM from a CRO standpoint. She explored the following questions:
  • What changes impact the request for proposal costing for RBM vs ‘normal’ monitoring scenarios?
  • Are there any essential contractual changes that need to be negotiated early?
  • What and where are the potential wins and losses for CROs in RBM agreements?
  • Is the financial risk to CROs slowing the potential rapid adoption and benefits for sponsors?
She concluded that we are somewhere in the middle of the ‘adoption curve’ linking denial, resistance, testing and integration. Kieran Doran of University College Cork and Ann Meeker- O’Connell of Johnson & Johnson followed up with a discussion on the likely next steps in the industry’s application of RBM.

People Power

In a change of tack, Thierry Escudier, Head of Clinical Operations at Pierre Fabre Medicament, and Michelle Noble, Director Resourcing Europe with Novella Clinical Resourcing, asked whether people are a clinical trials greatest asset, or its biggest risk?

They explained that all our business is driven by regulations, standard operating procedures (SOPs), contracts and guidelines, but nevertheless it is people who ultimately manage and deliver projects, and much depends on the individuals themselves.

Building on this, they gave the results of a two-part survey – of pharma companies and CROs – that cross-evaluated expectations and explored resource issues, such as:
  • Who is going to do the job?
  • Who has the responsibility for choosing staff?
  • What are the primary competencies?
The survey underlined some of the differences between sponsors and CROs in terms of expectations and practices, prompting the presenters to suggest that pharma-CRO working groups should be created for projects, with the objective of defining resource expectations and processes between the two parties.

The next presentation came from Simon Addyman of Transport for London, who is the Project Manager of the Bank Station Capacity Upgrade Project in London. This £660 million initiative features six closely knit multidisciplinary and multi-organisational communities which make up an information exchange network, with specific themes across organisations and functional disciplines. As this huge and diverse project was described, I think everybody in the audience was reminded that the pharma industry does not have a monopoly on complexity, and that we should not be reluctant to learn from the experience of other sectors.

Closing the first day was the Oxfordstyle debate, where the motion was: ‘This house believes that the procurement process has damaged sponsor-CRO relations and the conduct of clinical trials.’ Supporting the motion were Anna Matranga, Senior Director, Global Scientific Affairs and Strategic Sourcing at Ipsen Innovation, and R&NR Consulting Ltd’s Roger Joby. Standing against were Jean Edwards, Eli Lilly’s Procurement Director, Europe, Australia & Japan, and Vanessa Cooke, Global Head, Strategic Sourcing R&D with Bayer Healthcare Procurement. It was a closely contested discussion, but the motion was narrowly defeated.

Complexity and Compliance

On the second day, Stephen Carver from Cranfield University School of Management offered a stimulating talk, with views from other industries on complexity – structural, cultural or a combination – giving the audience plenty food for thought.

The conference then turned to compliance, with Marie-Claire Pickaert , Deputy Director General of the European Federation of Pharmaceutical Industries and Associations, discussing the current regulatory scene, and Uffe Rasmussen, Lundbeck’s Chief Compliance Officer, outlining new compliance requirements in pharma and how they are affecting cooperation with CROs. Following on from this, Corina O’Connell, Associate Director, Transparency Reporting at ICON, detailed how a CRO implements the reporting requirements of EFPIA/ the US Sunshine Act, which concern payments to healthcare professionals. It seems to me that compliance – and to be seen to be complying – is an ongoing nightmare for the clinical research industry.

A wider view was given by Paul Strickland, an independent quality assurance consultant, as he considered whether R&D is meeting all other related requirements – and to what extent they are integrated with good business practice. The solution, he said, lies in planning, and in particular implementing a corrective and preventative action plan to fix the process – which many in the industry are already doing.

Finally, Pauline van Heiningen, Senior Manager Operations and Compliance at ReckittBenckiser, presented her company’s latest thoughts on compliance. She explained that in 2014, its Health Clinical Team went back to the drawing board to define a new clinical management system to support the variety of studies it was undertaking. The revised strategy involves new SOPs and a renewed approach to how the company deals with supplier relationships.

Room 101

During the event, a number of industry pet hates were nominated to be consigned to ‘Room 101’, and the verdict was announced at the conclusion of this year’s conference. In this light-hearted exercise, the competing hates were:
  • Sponsors who insist on experienced-only teams
  • Industry panel discussion at conferences
  • Badly designed patient paper diaries
  • Over-engineered bid defence meetings
  • Dependence on the 36-Item Short Form Health Survey
It was the last, rather niche hate that ‘won’: the SF-36 survey is a set of quality-of-life measures, dependent on patient reporting, that are now widely used by care organisations for routine monitoring and assessment. The ‘Room 101’ sponsor, World Courier, provided a charity donation for the winner.

The 2015 PCMG event lived up to its reputation of being informative, innovative and enjoyable. I would urge any executive involved in outsourcing to attend next time, wherever it may be.

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