CCRN Involving Industry

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CCRN - Involving Industry

• Clare Morgan
• UKCRN Assistant Director - Industry

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Issues associated with conducting clinical
research in the UK

• Time
• Long set-up times for UK trials -research
  governance bureaucracy
• Unreliable patient recruitment
• Cost
• Delayed study set-up due to cost negotiations
• Variable trust overheads and cost transparency
• Quality
• Poor data quality due to inconsistent training of
  research staff
• Inadequate investigator / researcher commitment
  involvement in trials

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Key targets

• To improve the UK Clinical Research environment
  for Industry sponsored studies by addressing
• Speed
• Reliability
• Quality
• Value

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• Studies that require formal consideration but if
  accepted have a high priorityOne of the aims of
  the NIHR CRN is to facilitate studies of benefit
  to patients that are sponsored by industry. A
  specific adoption process has therefore been
  developed by the UKCRC Industry Road Map Group to
  enable these studies to be part of the Portfolio.
  Studies that are accepted into the Portfolio in
  this way involve full cost recovery from
  industry.

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TCRN Industry Involvement
Number of unique companies
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Key Differences Between CCRN and TCRN Involvement
for Industry

• TCRNs
• Dedicated TCRN coordinating centre
• Support a single portfolio topic
• Draw expert advice from CSGs/ network leads
• Will receive RMG support from CLRNs

• CCRN
• UKCRN industry team will act as coordinating
  centre
• Will support all portfolio topics
• Draw expert advice from the Specialist Network
  Groups
• Have capability to influence RMG through CLRNs

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What topics are covered by CCRN?

• Blood
• Cardio
• Congenital disorders
• Complementary therapies
• ENT
• Eyes
• Genetics
• Geriatrics
• HIV
• Infectious diseases
• Injuries and accidents
• Musculoskeletal
• Nutrition
• Obs and Gynae
• Oral and Gastrointestinal
• Public Health
• Renal and urogenital
• Respiratory
• Skin

• PLUS existing priority topics
• Cancer
• Dementias Neurodegenerative Diseases
• Diabetes
• Medicines for Children
• Mental Health
• Primary Care
• Stroke

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How will the CCRN interact with Industry?

• Single Point of Contact Industry team at UKCRN
  CC
• Subject Specific Input i) Chair SNG
• ii) SNG members
• Clear, quick, simple Electronic
• Do-able, Adoptable, Feasible (SNG)
• In parallel Log on to central sign-off
• Apply costing template/review contracts
• Biostatistical check

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The Process
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What will the CCRN offer?

• Study delivery to promised targets
• Shared performance goals
• Network monitoring and performance management
• Rapid access to new sites and patient populations
• Experienced and trained research staff
• Small to large trials
• Single point of contact for network sites
• Rapid site set up through streamlined RMG
• UKCRN badging of trials

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Study feasibility through UKCRN

• LEVEL 1 Do-ability, Top level feasibility,
  Country feasibility, Study feasibility
• Rapid assessment to determine if the UK has the
  required subject population for the study and if
  the treatment plan proposed in the protocol
  differs fundamentally from the standard UK
  treatment pathway.
• LEVEL 2 Detailed feasibility, Site
  feasibility, Site capability
• Identify potential sites that could conduct the
  study, addressing site specific issues such as
  research resources - skills, facilities, and
  equipment.

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Standard agreements contracts

• Adoption of the unaltered mCTA by companies and
  CLRN Trusts
• Generic confidentiality agreements allow rapid
  assessment of feasibility
• Company/network agreement to define
  responsibilities, timelines, study requirements
  and share performance goals

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CCRN performance management of portfolio trials

• Emphasis on feasibility assessment to accurately
  predict patient numbers and timelines
• Overarching management of trial performance
  within CLRNs
• 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

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Consistent transparent costing guidelines

• Transparency of costing breakdowns, using the
  costing template
• Appropriately allocated overheads, plus capacity
  building
• Consistent costing (with a transparent basis for
  any necessary adjustments)
• Pricing index for NHS research investigations
  which will inform activity based funding
  allocation
• Standard method of adjustment for locality
  differences
• Overall goal to fast-track cost negotiation of
  trials

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Streamlined research governance

• Central Sign-off will benefit multi-centre trials
  by supporting rapid set up through streamlined
  and consistent research governance
• UKCRN CSO team will
• Collate evidence of all national relevant
  regulatory and ethics approvals
• Gain local assurance that study
  agreements/funding and sponsor responsibilities
  and capacity issues are addressed
• Obtain local sign off of contracts and local
  approvals to defined time based metrics
• Ensure that that there is CLRN provision in each
  trust to support a delegated signatory
• Indicate to TCRN/UKCRN, CLRNs and Trusts that
  Central Sign-off is confirmed and that NHS
  approval letters can be issued

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CCRN and Industry

• Expect first CCRN industry studies to be adopted
  by April 08. Dependant upon
• CLRN infrastructure in place to deliver to
  metrics
• Functioning Specialist Network Groups
• Identification of CLRN special interests
• Phased adoption of studies by CCRN topics
• Definition of the investigation pricing index and
  continued pilot of the costing template
• CCRN roadshows planned for Industry in spring 08

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The Vision

• CCRN will provide an opportunity for commercial
  research to thrive in the UK. We must build upon
  the UKCRN experiences of developing network
  interactions, to ensure that UKCRN supports
  industry to effectively deliver trials, in order
  to secure benefits for patients.
• Standardisation
• Consistency
• Clarity
• Reliability
• Speed

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Clare MorganUKCRN Assistant Director -
Industry Email c.morgan_at_ukcrn.org.uk