The Future of Clinical Trials

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The Future of Clinical Trials Research in the
NHS Sally C Davies UK Trial Managers
Network, May 2004
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• To us, science and research constitute a
  front-line service, as they too, reduce distress
  and pain and save lives
• Dr John Reid, Secretary of State for Health, 22
  March 2004

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MISSIONTo provide evidence on which to base
improvements in the health of individuals and the
management of disease
DH / NHS RESEARCH AND DEVELOPMENT

• Objectives
• Support the UK Science base

• Research into areas of need and priority for the
  NHS

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• Drivers for Change
• Historical under funding full economic
  costs
• Payment by Results
• Academy of Medical Sciences Strenthening
  Clinical Research
• BIGT (PICTF, HITF Industry lobby)
• Wanless 2 Report
• Research Governance
• Follett
• Increased Regulation
• Capacity concerns (numbers, type career
  structure)

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• Clinical Research is changing how?
• Research Governance
• Challenges facing R D in the NHS
• eg EU Directive
• the UK CRC
• DH investment including
• networks
• the pressures
• the future.

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Clinical Research Elements
Extra diagnostics Beds Governance
Management
Equipment Space Trained staff IM T
Leadership -protocol -sponsorship -data
collection -analysis -write up
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Barriers to Clinical Research
Clinical research in a time of change Targets Capa
city Underfunding Consultant GP
contracts Collaboration roles undervalued Foundati
on trusts Payment by results
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Research for Patient Benefit Working Party

• A UK Clinical Research Collaboration
• to oversee
• extension of research infrastructure in the NHS
• co-ordination and development of research career
  pathways
• development of better regulation practice

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Budget 2004

• UK CRC
• Clinical Networks
• Older patients (stroke, diabetes, Alzheimers)
• Expand Mental Health R Network
• To develop drugs for use in children faster

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UK Clinical Research Collaboration
To work in partnership (cf NCRI) DH, NHS, MRC,
Wellcome, Acad Med Sci, Industry, AMRC, Patients
more To develop NHS based Clinical
Research (networks, clinical research facilities
and training) Sort Academic careers Work to
Better Regulation
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UK Clinical Research Collaboration
Established by Ministerial Directive -with an
executive team (at the MRC) -gtESTABLISH Work
streams 1 Paper on barriers, levers incentives
to research in the NHS -gtIMPLEMENTATION 2 Set
up groups to establish networks 3 Review
Millenium CRFs (-gtmore) 4 Sort Careers 5
Regulation?
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UKClinical ResearchCollaboration
ComprehensiveClinical ResearchNetwork
CancerResearchNetwork
NextResearchNetwork
Directionnext NRI
DirectionNCRI
?
Co-ordinationnext NCC
Co-ordinationNCC
Co-ordinationUK CRCC
Operationnext NRN
OperationNCRN/NTRAC
OperationUK CRN
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Network Structure
Leadership by National subject
specialist /or local enthusiast Shared process
es paperwork SOPs for GCP, pharmacovigilance
etc National Data capture system Network of
regulatory expertise advice Training support
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Budget 2004NHS R D monies
Year m NHS spend 03-04 533 0.87 04-05 581
(25) 0.86 05-06 626 (50) 0.84 06-07 651
(75) 07-08 676 (100) Similar rises anticipated
for the MRC to spend on Clinical Research
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Research Governance Framework

• Improves research quality and safeguards the
  public by
• enhancing ethical and scientific quality
• promoting good practice
• reducing adverse events and ensuring lessons are
  learned
• preventing poor performance and misconduct

• Sets standards
• Defines mechanisms to deliver standards
• Describes monitoring and assessment arrangements

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Sponsors Role

• Quality assurance
• proposal safe, worthwhile
• ethics approval
• research environment
• trials registration
• CI and researchers
• Resources to deliver
• data quality
• RD to protocol

• Agreement on
• responsibilities
• management
• monitoring
• intellectual property
• dissemination
• Review safety, design
• Independent expert advice
• compensation

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EU Directive on Clinical Trials

• Harmonises the regulation and conduct of clinical
  trials across the European Union (EU)
• Covers all aspects of the conduct within the
  European Union EU of clinical trials on medicinal
  products involving human subjects
• The DH Research Governance Framework sits
  alongside

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EU Clinical Trials Directive

• Responsibilities Liabilities
• NHS bodies remain liable for clinical negligence
  and other negligent harm to individuals covered
  by their duty of care
• Institutions employing researchers remain liable
  for negligent harm caused by the design of
  studies they undertake
• Producers continue to have strict liability for
  faulty medicines

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New Lexicon

• Competent Authority (MHRA)
• IMPs
• GCP, (ICH)
• GMP
• Qualified person
• EUDRACT
• Sponsor

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Infrastructure - what next ?

• Cardiovascular Disease
• Neurodegenerative diseases
• Respiratory disease
• Musculo-skeletal disease
• Older people
• Renal
• Infectious disease

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What is the role of Trust RD Offices?
Implementing, facilitating managing policy,
including R Governance -DH -NHS
RD -Local Accountability (
NRR) Costing Contracting University
liaison Records conflicts competing studies
Sponsor role -Study initiation -Monitoring
protocols recruitment - Data monitoring
committee -Adverse events reports -Random
audits -Coordinate monitoring visits
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Common Questions
Should the trust or Medical School or University
be Sponsor? Why should Trusts take on Sponsor
role?

Will manufacturers assist in authorisation
submissions to MHRA? How will Qualified Person
GMP work for small companies Biotech? Can NHS
specialist pharmacy production units supply?
GCP at ICH standard or MRC?
Who will fund extra costs?
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The Future DH R D Grouping

• DH core group
• Whitehall business
• Policy / Strategy
• Commissioning (at high level)
• Governance
• Commissioning Centres
• HTA, SDO etc
• UK CRC
• NCRI
• Networks disease / theme specific generic

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• Discussion Points
• generic versus specialist networks?
• how to find develop the
• manpower?
• how do individuals input?
• what is the role of individual
• Trusts StHAs?
• what is the relationship with
• industry to be?
• the place of Innovation?

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DH / NHS RESEARCH AND DEVELOPMENT
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National Programmes

• Health Technology Assessment (HTA)
• Service Delivery and Organisation (SDO)
• Innovation
• Capacity Building (including trials units
  networks)
• Methodology
• Support Funding to the NHS
• (including PNF)
• Policy Research Programme

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Whats new in Version 2?

• Addition of footnotes cross referring to
  Regulations where appropriate
• MCA gt MHRA
• Definition Changes
• Investigator PI at any one site
• Chief Investigator overall PI (1 only)
• Sponsor
• Organisation (or individual) that takes ultimate
  responsibility for the study
• Takes lead in confirming arrangements for
• - Initiation (ethics, peer review, MHRA
  authorisation,
• Financing)
• Management
• Financing

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EU Directive on Clinical TrialsResponsibilities
liabilities
NHS bodies liable for clinical negligence -
(including honorary medical academics) Employers
liable for negligent harm caused by design of
studies they initiate Producers liable for fault
medicines No-fault compensation ie when no legal
liability not covered by NHS indemnity to be
decided case by case by ethics committees (Public
bodies cannot agree advance payment for
non-negligent harm)
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