Clinical research NHS Primary care perspective Dr Amrit Takhar

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Clinical research NHS Primary care perspective
Dr Amrit Takhar
www.wansfordgp.nhs.uk/research
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WANSFORD SURGERY

• 6100 PATIENTS
• 4 PARTNERS
• TWO SITES
• RURAL DISPENSING
• TRAINING PRACTICE

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Research perspective

• Practice research activity development
• Why we do research
• Research practicalities
• Challenges that face us
• Governance and the PCT

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Great research is crucial

• saves lives
• saves money
• creates new ways of understanding where we are
  and what is possible
• transforms health workers with new skills and
  ways of seeing

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old infrastructure

• research literacy in context
• Working in academic isolation
• insufficient support
• insufficient supervision
• Lack of career structure / guidance

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Developments

• Research training and skills
• Extended study leave
• Msc thesis by research
• Practice support and capacity
• Clinical research nurse support
• Funding and time
• Infrastructure setup costs in practice
• Buildings, storage

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RESEARCH HISTORY

• 1981 Takhar , A and Kirk, C, Vasopressin
  receptors
• Biochemical Journal 194 67-172
• 1989 Pravastatin safety and efficacy study
• 1990-2000 One research study per year
• 2001-7 5-6 studies per year development of a
  research department w th dedicated research
  nurse and admin support. Protected time for
  clinicians.
• 2004 MSc by Research Information systems

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Why do we do research?

• Patient perspective
• Practice perspective
• Personal perspective

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Patient reasons to do trials

• Access to study drug not otherwise available to
  them
• Access to tests not otherwise available to them
• Value the extra time available
• Like the full MOT
• True altruism
• Better supervision of their condition (more
  intensive)
• Social therapy!

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Not all patients are suitable for trials
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Practice reasons to do trials

• Quality
• Innovation-lead the way
• Financial
• Status
• Service to patients

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Personal reasons to do trials

• Interest
• Knowledge benefits
• Challenge to develop the research activity and
  establish and run it as a stand alone business
• Networking with other researchers

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Research practicalities - 1

• Work from major pharmaceutical companies and
  Contract Research organisations such as Parexel
  and Quintiles
• Initial offer of work requires detailed
  feasibility-can we do it and do we want to?
• Trial agreed and placed with practice
• PaperworkMeetings..!!!
• Find the patients- computer searches, referrals
  from other clinicians

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Research practicalities - 2

• Write to suitable patients
• Follow up phone call
• Detailed information (PIL) sent to those
  interested
• First appointment booked for consenting
• Deadlines and performance pressure
• Quality checks (monitoring) and audit
• Storage and archiving
• Practice commitment

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Challenges that face us

• Trials are not an easy option and they are
  getting tougher
• Legal issues
• Business pressures
• Variations between companies-5 different ways to
  write the date for example!
• Cash flow
• Practice involvement

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You can be audited
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Challenges that face us during trials

• Pressure to achieve targets-competitive
  recruitment
• Unrealistic demands from the drug company
• Protecting patient rights e.g. recruitment
  closed, patients doing trials for the wrong
  reasons
• Escalating documentation
• The computera mystery to most
• Changing regulations esp ethics process
• The involvement of the PCT

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Research trial pitfalls

• unclear questions (grandiosity, gigo,
  insufficient analysis of the problem)
• duplication
• weak, cheap studies
• insufficient power
• insufficient follow-up
• selection bias
• group contamination

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Academic Research pitfalls

• 90 medical research unreliable and irrelevant to
  practice
• still 5-15 year gap for getting good research
  into practice
• insufficient writing skills
• inability to accept overhead costs

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GP research

• RCGP formed 1952
• No academic departments of General Practice
• No professors of General Practice anywhere in the
  world
• 1990 300 GP academics in UK (1)
• Need for increase in Research infrastructure

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GP research critical success factors

• GP motivation
• Research training and skills
• Practice support and capacity
• Funding and time
• Infrastructure setup costs in practice admin
  support and record keeping
• Seeking research funding
• Approval and registration

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Barriers to quality research culture

• Lack of ownership and commitment
• Major knowledge and skills gaps at all levels
• No established links with research institutions
• Conflicting priorities and no protected time
• No protected funding for research infrastructure
• Poor physical space, IT systems near-obsolete
• No history of involving patients in research

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Developing research practices

• Primary Care Research Networks (PCRN)
• Local research fora /- voluntary sector
• Research PCTs and consortia
• University links (advice, courses, degrees)
• RCGP Primary Care Research Team Award
• Public health research networks

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Quality research culture

• Respect for the dignity, rights, safety and
  well-being of research participants
• Valuing diversity (not ageist, racist etc)
• Personal and scientific integrity
• Leadership
• Honesty, accountability and openness
• Clear and supportive management

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The Practice as a Research Environment

• Creating a Research Culture
• Involvement in innovations and advances
• Awareness of research limitations
• Achievable with support, training and resources

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