List of Clinical Research Companies in India

							Industry Research in the UKCRN
 (UK Clinical Research Network)

             Dr H Howard
             Prof R Kaplan



       UK Clinical Research Network (UKCRN)
Industry trials & UKCRN

   Background of the UKCRC & the UKCRN
   Organisation of UKCRN
   Role of industry research in the UKCRN mission
   Value of industry research to the NHS
   Barriers
   Work in progress
   Way(s) forward



                UK Clinical Research Network (UKCRN)
Industry Research in the UK

 UK has strong history of clinical research – number of
  global and UK-based pharmaceutical, biotech & medical
  device companies engaged in research
 Roughly 25% world‟s top 100 medicines developed in UK
 Now increasing global competition to attract investment
  from biomedical industry
    US has commanding lead
    Europe now competing with „new‟ research locations for
     second place (e.g. India, China, Eastern Europe, S.
     America)

                 UK Clinical Research Network (UKCRN)
The Challenge for the UK
 Industry under cost and time pressures:
    New medicines typically take 12 years and ~£350m or
      more to develop
    Companies under pressure to ensure reliable, on-time
      delivery of quality data, within budget
 UK at risk of losing position as preferred research site due
  to lack of reliability factors critical to industry:
    Timeliness – too many examples of Trust set-up abandoned by
     companies; non-recruiting Trusts; low recruiting Trusts
    Cost – relative higher cost-of-living in UK accepted, but delayed
     Trust set-up & unreliable recruitment = avoidable additional cost
    Quality – variations in data quality due to inconsistent training of
     research staff & standard procedures


                    UK Clinical Research Network (UKCRN)
BIGT, AMS, RPBWP Reports

                                                                 10/03-03/04 - reports from Bioscience Innovation & Growth
                                                                 Team & Academy of Medical Sciences identified key areas in
                                                                 which UK could improve its competitiveness by building
                                                                 “mutually advantageous” collaboration between NHS and
                                                                 industry – followed by recommendations of RPBWP:

                                                                                  • NHS Clinical Trials Network
                                                                                  • Establish UKCRC to improve national
                                                                                    health and increase national wealth
                                                                                  • NHS research infrastructure
 RESEARCH FOR PATIENT
 BENEFIT WORKING PARTY
                                                                                  • Clinical research facilities for
                                                                                    experimental medicine
             FINAL REPORT
                                                                                  • Incentives for research in the NHS
   “For us, science and research constitute a
 front-line service, as they too, reduce distress
                                                                                  • Clinical research programmes
             and pain and save lives”.
  (Dr John Reid, Secretary of State for Health, 22 March 2004)                    • Research workforce
                                                                                  • Improved regulatory environment

                                                                 UK Clinical Research Network (UKCRN)
UK Response
 DoH announcement March 2004: £100m increase in NHS R&D funding
  (in England) by 2008
 UK Clinical Research Collaboration (UKCRC) established - new
  partnership between government, NHS, voluntary sector, private sector,
  and public
 Objective: to transform the clinical research environment in the UK by -
     Taking strategic oversight of clinical research
     Identifying gaps in clinical research capability
     Coordinating approaches between funding bodies to fill gaps and
       take advantage of opportunities
     Providing leadership to develop the profile of the clinical research
       and enhance the research culture of the NHS
     Monitoring progress in implementing plans and in achieving
       objectives

                    UK Clinical Research Network (UKCRN)
UKCRC workstreams
 Building up the infrastructure in the NHS
       Clinical Research Networks
       Experimental Medicine, including development of national
        framework of clinical research facilities
 Building up the research workforce
       Phase 1 Academic Medicine
       Phase 2 Other Researchers
 Building up incentives for research in the NHS
       Clinicians
       NHS managers
 Coordinating Research Funding Activity
       Strategic analysis of clinical research funding in the UK
       Develop joint initiatives in public health research
       Develop coherent approaches to funding of network areas
 Streamlining the Regulatory and Governance Processes

                  UK Clinical Research Network (UKCRN)
UK Clinical Research Network
Aim: To take forward the UKCRC‟s remit to develop a world-class health service
infrastructure in the UK to support clinical research by facilitating the conduct of
randomised trials of interventions (including prevention, diagnosis, treatment, and
care) and other well designed studies.
 Managed set of Clinical Research Networks, initially targeting six priority areas:
      Cancer                                        (NCRN)
      Dementias & Neurodegenerative Disease (DeNDRoN)
      Diabetes                                      (DRN)             Six Topic-specific
                                                                       Clinical Research
      Medicines for Children                        (MCRN)            Networks (TCRNs)
      Mental Health                                 (MHRN)
      Stroke                                        (SRN)
 Research projects funded by both commercial & non-commercial organisations will
  be incorporated
 UK-wide working & inclusion of primary care infrastructure are critical
 Future intention to extend UKCRN to cover full spectrum of clinical need

                        UK Clinical Research Network (UKCRN)
NCRN Accrual (all & RCTs)
                                          14
                                                 Nonrandomised
     National Accrual as % of Incidence   12     Randomised


                                          10


                                          8


                                          6


                                          4


                                          2


                                          0
                                               National   2001/02    2002/03    2003/04    2004/05*
                                               Baseline

                                          *figures for 2004/05 are projections based on 8 months data


                                                  UK Clinical Research Network (UKCRN)
                               Comparison of recruitment into Myeloma VII and Myeloma IX

                     800

                                     Myeloma VII recruitment
                     700
                                     Myeloma IX Recruitment
                     600
                                     Target
Number of patients




                     500


                     400

                     300


                     200

                     100


                      0
                           0     1             2               3          4    5           6   7
                                                                   Year




                                     UK Clinical Research Network (UKCRN)
UKCRN Organisational Structure
                          Local Research Networks (LRN) x 34



                                     NCRN
   Local Research                  Coordinating                    Local Research
   Networks (LRN)                    Centre                        Networks (LRN)
         x8            SRN                                               x8
                                                     DeNDRoN
                    Coordinating                    Coordinating
                      Centre                          Centre
                                     UKCRN
                                   Coordinating
                                     Centre
                      MHRN                            DRN
                    Coordinating                   Coordinating
   Local Research     Centre                         Centre        Local Research
   Networks (LRN)                                                  Networks (LRN)
         x8                          MCRN                                x8
                                   Coordinating
                                     Centre


                         Local Research Networks (LRN) x 8

                    UK Clinical Research Network (UKCRN)
UKCRN Coordinating Centre
 National coordination of UKCRN activities
 Conduit for addressing barriers to trials at national level
 Development & provision of national systems &
  approaches to trial development & management
 Central team of ~30-35 staff with leads for the different
  workstreams
 Performance management of Topic-Specific
  Coordinating Centres
 Financial management of UKCRN
 Provides direct link with UKCRC Board/Partners
 Note: not coordination of scientific plans/portfolios

                 UK Clinical Research Network (UKCRN)
Topic-Specific Coordinating Centres

 Scientific portfolio development
 Performance management of Local Research Networks
 Provision of topic-specific training
 Coordination of consumer involvement
 Links with relevant trials units
 Main point of contact with UKCRN Coordinating Centre
 Communication with UKCRN Coordinating Centre about
  barriers to trials
 Note: not coordinating the trials themselves


               UK Clinical Research Network (UKCRN)
  TCRN Coordinating Centres


      Professor Gary Ford
Director, Stroke Research Network
             (Newcastle)                                                            Professor Rick Kaplan
                                                                                Acting Director, National Cancer
                                                                             Research Network (Leeds & MRC CTU)




  Professor Ros Smyth Director,
  Medicines for Children Research
              Network
            (Liverpool)                                                             Professor Til Wykes
                                                                              Director, Mental Health Research
                                                                             Network (Inst Psych & Manchester)




     Professor Martin Rossor
      Director, Dementias and
                                                                                     Professor Des Johnston
Neurodegenerative Diseases Research
                                                                               Director, Diabetes Research Network
    Network (UCL & Newcastle)                                                            (Imperial & Oxford)


                                      UK Clinical Research Network (UKCRN)
Local Research Networks (LRNs)
 Defined geographical area incorporating multiple acute &
  primary care Trusts
 Allocated funding for staff:
    Clinical Lead for Research
    Research Network Manager
    Research Nurses & other research staff
    Admin support
    Clinical support (e.g. pharmacy, radiology, pathology)
 Close links with local service provision
 University links
 Network builds on and supplements existing local
  teams/infrastructure
                     UK Clinical Research Network (UKCRN)
Roll out of UKCRN Networks

 Cancer (NCRN) – 34 Local Research Networks (LRNs)
  in England (41 across UK), established 2001
 Mental Health (MHRN) – 8 LRNs, established 2003
 Medicines for Children (MCRN) – LRNs to start April
  2006
 Stroke (SRN) – LRNs to start ~May 2006
 Dementias and Neurodegenerative Disease
  (DeNDRoN) – some LRNs to start ~May 2006; others
  identified to follow
 Diabetes (DRN) – LRNs to start ~May 2006

              UK Clinical Research Network (UKCRN)
UKCRN Key Workstreams
    Trials and Trials Unit Links

    Regulatory and Governance

    Industry Links
    Primary Care Links

    Experimental Medicine

    Training and Education

    Information Systems

    Consumer Involvement

               UK Clinical Research Network (UKCRN)
UKCRN Industry Team
                            UKCRN Coordinating Centre
                   UKCRN Associate Director for Industry: Rick Kaplan
                   UKCRN Industry Lead: to be appointed
                   UKCRN Senior fellow - Industry: Helen Howard
                   UKCRN Senior fellow - Industry: Anne Davies

     NCRN Coordinating Centre                    DeNDRoN Coordinating Centre
 NCRN Industry Lead: Rick Kaplan             DeNDRoN Industry Lead: Colin Dingwall

       DRN Coordinating Centre                    MCRN Coordinating Centre
 DRN Industry Lead: Nishi Chatuverdi         MCRN Industry Lead: Tony Nunn

     MHRN Coordinating Centre                        SRN Coordinating Centre
 MHRN Industry Lead: Tony David              SRN Industry Lead: Philip Bath

                         Secondment Post(s) from Industry
                          First to be appointed Spring 2006

                      UK Clinical Research Network (UKCRN)
Role of Industry Trials in UKCRN
 Effective collaboration with the UK pharmaceutical,
  biotech & device industries is one of the founding
  principles of UKCRN
 UKCRN will assist UKCRC partners in improving
  the clinical research environment for industry in the
  UK – and in the process improve the research
  environment overall
    Scale & scope of the initiative  momentum for progress
 Industry-led and investigator-led trials both belong
  in the portfolio

                UK Clinical Research Network (UKCRN)
Benefits of Industry Research

 If a commercial trial – performed in the NHS –
  speeds licensing of an effective new agent . . .
    Both patients & sponsor benefit directly
    Future 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
               UK Clinical Research Network (UKCRN)
Funding of health-related R&D


                                   Industry



                      Charities                    DH
                                     MRC




 (from the House Select Committee report on the pharmaceutical industry 3/05)

                    UK Clinical Research Network (UKCRN)
What does Industry want/need
from us?
 Speed and reliable data, at reasonable cost
    Speed, speed, speed:
       Rapid study activation, completion of enrolment &
        availability of data
       Efficient R&D and ethics approval & costing
       Confidence that enrolment goals will be met
    Confidence that the data quality will meet
     regulatory standards
 „One-stop shop‟ for series of agents and trials
 Expert advice and „badging‟ (but note that these are
  low on the list of importance)

                 UK Clinical Research Network (UKCRN)
Common concerns / obstacles
 Delays & uncertainty of local R&D approvals
 Aligning study time frame with (global) development
  plans
 Will sites be able to deliver on enrolment
  commitments?
 Will data meet all regulatory standards?
 „One-stop shop‟ possible?
 Some key members of dispersed trial team may not be
  included in initial discussions
 Delays in relation to funding & peer review decisions
  (partnership trials)
              UK Clinical Research Network (UKCRN)
Industry partnership working
Optimised partnerships will benefit from:
 Establishing or strengthening industry relationships by
  successful delivery of contract trials
 Ongoing partnerships across multiple projects,
  promoting:
    Dialogue & strategic planning
    Advance consultation
    Collaboration on both early-phase and late-phase
     trials
 Support & problem solving at coordinating centres
 Central points of contact
 Standardised agreements, contracts, costing, logistics

                UK Clinical Research Network (UKCRN)
Some key objectives
 Development of national framework for networks to carry out
  industry trials efficiently – and for industry to collaborate with
  networks (early and late trials)
 Understanding barriers to industry involvement and developing
  solutions to address these barriers, e.g.:
    Mandated application of standard processes for network
     studies:
    mCTA and costing model
    Streamlined multi-site R&D approval
 Performance management of Trusts participating in network
  studies through development of clear metrics including:
      Number of industry studies adopted
      Study set-up time
      Recruitment delivery according to mutually agreed targets
      Data quality


                      UK Clinical Research Network (UKCRN)
Industry Road Map Group
 Department of Health               Industry sector
  Louise Wood               Peter Arnold (Smith+Nephew)
  Jill Dhell                Alan Boyd (Ark Therapeutics)
  Mark Lewis                Giles Campion (GE
                              Healthcare)
 UKCRN
                             Nick Deaney (MSD)
  Colin Dingwall (DeNDRoN)
  Nishi Chaturvedi (DRN)    Stuart Dollow (GSK)
  Tony Nunn (MCRN)          Joanna Nakielny (Eli Lilly)
  Tony David (MHRN)         Judith Syson (AstraZeneca)
  Philip Bath (SRN)         Craig Stevenson (Pfizer)
  Anne Davies (UKCRN)
                             Gwyn Thomas (Wyeth)
  Helen Howard (UKCRN)
  Rick Kaplan (NCRN/UKCRN)  Anthony Walker (Onyvax)


                  UK Clinical Research Network (UKCRN)
Industry Roadmap Group goals -
facilitating industry trials in networks

 Focus on:
    Speed of commitment
    Speed of trial set-up
    Speed of delivery
    Quality of data
    Consistency of agreements & arrangements
    Cost of service
    Building up the basis for partnership
      working

             UK Clinical Research Network (UKCRN)
Industry Road Map Group
High Priority Recommendations
 A streamlined national R&D sign-off process for multi-centre
  trials (including honorary passport scheme)
 Mandatory use of mCTA & a standardised costing method
 Standing Trust/University contract agreements in place
 Inclusion of commercially sponsored research in NHS
  metrics and targets
 Integration of Primary Care into research networks
 UK-wide working
 Implementation of „comprehensive‟ or „generic‟ capacity
 Ring-fenced clinician and clinic time and resources
 Interface with Connecting for Health
 Promotion of long-term collaborations, beyond single trials

                 UK Clinical Research Network (UKCRN)
Feasibility & Adoption Panels
 Process developed for very rapid assessment by Topic
  Networks of commercial trial feasibility (availability of
  eligible patients, competing trials, clinician enthusiasm, etc.)
 Standing panel of experienced trialists to assist Network in
  confirming suitability of trial
    1) Does the trial have a genuine & testable hypothesis with a possible future
       benefit for patients as its major objective?
    2) Is the statistical design valid and reasonable for the stated main objective &
       main hypothesis of the trial?
    3) Has there been peer review of the trial & its design by experts independent
       of the company sponsor?
 Pilot experience with this approach has been successful
 Two-week turnaround can be accomplished

                       UK Clinical Research Network (UKCRN)
Opportunities for UKCRN

 To embrace the challenge and develop a world-class
  health service infrastructure to support clinical
  research
 To make the UK an attractive place for industry
  collaborations
 To improve the speed of clinical trials
 To network those involved in clinical trials
 To provide a qualified and trained workforce to
  support national clinical research
 To improve patient treatment and care


              UK Clinical Research Network (UKCRN)
Our questions for this
workshop
Can the network initiative kick start the transition to
highly standardised agreements & contracts?
. . . by requiring for all network multi-centre trials that
Trusts & Universities (& companies? . . .) sign up to :
    uniform use of the mCTA?
    uniform use a single implementation of the costing
     guidance for any single multi-centre trial?
    a standard package for implementation of costing
     guidance across all UKCRN trials?



                UK Clinical Research Network (UKCRN)
UKCRN Industry Team
                            UKCRN Coordinating Centre
                   UKCRN Associate Director for Industry: Rick Kaplan
                   UKCRN Industry Lead: to be appointed
                   UKCRN Senior fellow - Industry: Helen Howard
                   UKCRN Senior fellow - Industry: Anne Davies

     NCRN Coordinating Centre                    DeNDRoN Coordinating Centre
 NCRN Industry Lead: Rick Kaplan             DeNDRoN Industry Lead: Colin Dingwall

       DRN Coordinating Centre                    MCRN Coordinating Centre
 DRN Industry Lead: Nishi Chatuverdi         MCRN Industry Lead: Tony Nunn

     MHRN Coordinating Centre                        SRN Coordinating Centre
 MHRN Industry Lead: Tony David              SRN Industry Lead: Philip Bath

                         Secondment Post(s) from Industry
                          First to be appointed Spring 2006

                      UK Clinical Research Network (UKCRN)
www.ukcrn.org.uk




UK Clinical Research Network (UKCRN)