1 / 16

Delivering with the Pharmaceutical Industry

Delivering with the Pharmaceutical Industry. R Kaplan NCRN Associate Director. Benefits of Industry Research performed in UK. Healthcare industry invests more on R&D within UK than any other business sector (>£3 billion p.a.)

Télécharger la présentation

Delivering with the Pharmaceutical Industry

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.


Presentation Transcript

  1. Delivering with the Pharmaceutical Industry R Kaplan NCRN Associate Director

  2. Benefits of Industry Research performed in UK • Healthcare industry invests more on R&D within UK than any other business sector (>£3 billion p.a.) • If a commercial trial – performed within the NHS – speeds licensing of an effective new agent . . . • Patients benefit directly, as well as sponsor • Future UK patients benefit if access is speeded • Trial income contributes to a larger/better research infrastructure • Sponsor is likely to expand portfolio of work with NHS • If the company is UK-based, study leads to additional contribution to UK economy

  3. Industry DH Charities MRC Funding of health-related R&D (from the House Select Committee report on the pharmaceutical industry 3/05)

  4. Why UK Pharma and DHare applying pressure to UKCRN • Industry estimates out-of-pocket costs average $1.2M (~£0.6M) per study for each month delayed, plus $0.8-5.4M (£0.4-2.7M) per day in potential lost sales • UK performance has been declining for several years, while other areas of the world have improved dramatically • >90% of commercial trials opened in UK have had substantial delays in enrolment, and many fail to deliver target numbers • Global companies are not placing studies in UK • UK pharma affiliates are being forced to downsize

  5. Industry Trials in UKCRN • Effective collaboration with the UK pharmaceutical, biotech & device industries is a founding principle of UKCRN • Trials need not come though or use the networks, but hopefully it will be advantageous to do so • UKCRN working with DH and industry partners to improve the clinical research environment for industry in the UK – and in the process improve the research environment for all clinical research • Scale & scope of the initiative  momentum for progress • Industry-led and investigator-led trials within the same overall portfolio

  6. Importance of Industry Studies • The ‘industry’ portfolio within the NCRN has become an area of major DoH focus • This should include both commercial studies (industry developed) and investigator-led partnership studies • . . . pharma lobbying focuses on commercial • These trials need to be considered joint top priority with major national investigator-led trials

  7. NCRN Industry Services: • Consultation • Feasibility • Costing & contracting • Governance & regulatory • Some elements of site set-up • Study delivery to targets

  8. NCRN (& UKCRN) offer to companies for commercial trials • Reliable UK feasibility & site selection • Coordinated contact with network sites • Rapid access to new sites and patient populations • Systems for expediting start-up • Rapid site set up via streamlined costing & RM&G • Study delivery to promised targets: • Experienced and trained research staff • NCRN ‘badging’ of trials • Shared performance goals • Network monitoring and performance management • Effective troubleshooting & sharing of good practice

  9. Standard agreements & contracts • Generic confidentiality agreements allow rapid assessment of feasibility • Adoption of the unaltered mCTA by companies and LRN/CLRN Trusts • Removes requirement of legal review from both sides • Reduces delays incurred through individual contract negotiations • Incorporates university sub-contracts • Company/network agreement to define responsibilities, timelines, study requirements and share performance goals • Standard, transparent costing methodology

  10. Consistent & transparent costing guidelines ­ & costing template • Transparency of costing breakdowns, using a consistent method • Appropriately allocated overheads* and fees for capacity building • Consistent (rather than identical) costing for multi-centre studies • Pricing index for NHS research investigations (which also will inform activity based funding allocation) • Standard method of adjustment for locality differences • Overall goal: to fast-track cost negotiation of trials

  11. Record to date • A few very small studies met their targets • Most of those with targets in the range of 50-120 are running well below their target accrual rates . . . but: • In most of the earliest NCRN adoptions, there was recognition that the studies were already in trouble • (thus companies were willing to try this very new approach) • In other cases, there have been continued very substantial delays for R&D (or other) approvals • Delayed UK or site start-up → little time to catch up before global trials finish • Many adopted trials experienced very substantial company/sponsor delays to study finalisation or activation after adoption and/or site selection • MHRA/FDA discussions, final design decisions, drug supply, etc. • But in many cases cause of company delay not communicated

  12. Performance management of portfolio trials • Emphasis on feasibility assessment to accurately predict patient numbers and timelines • Inter-hospital referral within Network, and inter-Network referrals for studies • Overarching management of trial performance within local networks • Clear communication between industry and NHS staff to define roles, responsibilities and expectations • Assure appropriate incentives for all parties • Additional layer of support to ensure delivery

  13. Performance management • RNMs and CC should agree site targets • Regular phone updates/discussions with sponsor’s trial manager • Regular e-mail interactions with RNMs for participating sites • Individual phone discussions with sites • Monitoring all activities via industry-tracking and portfolio databases • Pre site activation: • detailed checklist to cover all tasks associated with site selection, approvals and start-up, with assigned responsibilities – to be used as the basis for the sponsor-CC updates • After activation: • pro-forma for regularly assuring that sites, RNMs, sponsor, CC all have access to (identical) updated information & can effectively coordinate actions

  14. Some key issues • Inadequate communication lines amongst companies, site investigators/staff, relevant RNMs, and CC • Coordinators may only communicate with sites, ignoring RNMs & CC • RNMs – and CC – sometimes unclear as to which sites were selected, and about agreed target accrual and accrual rate • To date, most selected sites have been those with well developed and mature commercial trials operations, staffed by individuals who have operated largely independently of the networks and their managers • The number of DGHs with commercial trials is small, yet these are the sites whose activity has been most boosted by NCRN

  15. Some key issues (cont.) • NCRN portfolio is very large and until recently revolved primarily around investigator-initiated publicly funded research. This has led to an established and particular ethos and culture. • Many research staff and most clinicians have not yet fully absorbed the message about the critical role of industry studies and consequences for the UK if targets are not met • Might devolved architecture networks have a more difficult time in establishing influence over sites’ commercial trial performance? • Cross-network – and intra-network, cross-Trust – referral should be an important tool, but need to overcome organisational disincentives • Many continued challenges with pharmacy & imaging resources, staffing & capacity; ARSAC (radiation protection) licenses; R&D delays, contracting & costing (prior to new arrangements), etc.

  16. Working in Partnership

More Related