The Principal Investigator Role

Transcription

1 The Principal Investigator Role Jo Rodda Consultant in Old Age Psychiatry, NELFT North Thames CRN Dementia Specialty Lead

2 What is a Principal Investigator? The person responsible for the conduct of a research study at an individual site The nature of the role varies enormously between studies e.g. more responsibility for interventional studies compared to observational studies

3 The process of research in the NHS Stage 1: Idea, design and planning

4 The process of research in the NHS Stage 1: Idea, design and planning What is the problem? Identify research question Develop methodology Write protocol

5 The process of research in the NHS Stage 1: Idea, design and planning Stage 2: Applications and approvals

6 The process of research in the NHS Stage 1: Idea, design and planning Stage 2: Applications and approvals Stage 3: Study set-up

7 The process of research in the NHS Stage 1: Idea, design and planning Stage 2: Applications and approvals Stage 3: Study set-up Stage 4: Study conduct, recruitment and data collection

8 The process of research in the NHS Stage 1: Idea, design and planning Stage 2: Applications and approvals Stage 3: Study set-up Stage 4: Study conduct, recruitment and data collection Stage 5: Analysis and results

9 NIHR portfolio studies NIHR Clinical Research Network supports infrastructure for research in NHS NIHR Clinical Research Network portfolio High quality research Of clear value and relevance to the NHS Have some of funding provided by NIHR or other organisations The research standards that must be met are the same regardless of whether a portfolio study

10 Standards applying to research 1964: Declaration of Helsinki Practical standards for research built on Nuremburg code 1996: ICH Guideline for good clinical practice 2001: EU Clinical trials directive minimum set of standards for all EU countries Adopted into UK law as Medicines for Human Use (Clinical Trials) Regulations 2004 Updated 2006 to reflect EU Good Clinical Practice directive

11 Research Governance Framework Research Governance Framework for Health and Social Care 2005 Sets out standards for clinical research in NHS in England Requires that all research in NHS is carried out to same high standard No matter what focus or methodology

12 What are CTIMPs? CTIMP Clinical trial of an investigational medicinal product Regulated by the MHRA (Medicines and Healthcare Products Regulatory Agency) The competent authority for ensuring that regulations are applied to clinical trials conducted in the UK

13 What s a non-ctimp Non-CTIMPs are anything that isn t a CTIMP e.g. Questionnaire studies Data analysis studies Research using material donated from a Research Tissue Bank Research into psychological interventions Standard of conduct the same for CTIMPs and non-ctimps Some of the approval and reporting requirements that apply to CTIMPs do not apply to non-ctimps

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15 Responsibilities Sponsor Usually an NHS Trust, University, pharma or med tech company Overall responsibility for the study but can delegate functions

16 Responsibilities Sponsor Chief investigator Primary responsibility for conduct of the study at all sites Can delegate some duties but is still responsible for them

17 Responsibilities Sponsor Chief investigator Principal Investigator Responsible for initiation and conduct of the study at their site Can delegate some responsibilities to the study team but remains responsible for those functions

18 Responsibilities Sponsor CI PI PI PI Site Team Site Team Site Team

19 Approvals Health Research Authority (HRA) approval Issues single approval that summates all other approvals Favourable ethical opinion From research ethics committee For CTIMPs MHRA (medicines and products regulatory authority) Registered with European Union Drug Regulating Authorities Clinical Trials (EudraCT) database Some other specialist approvals E.g. gene therapy, radioactive substances

20 Study set-up (at each site) From site being considered to being ready to go PI responsible with support of study team Site identification Assessment of capacity and capability Practical arrangements Exchange agreements Initiation and start recruitment

21 Site file PI keeps file of study related documentation e.g. Protocol Patient info sheets Consent forms Data collection tools for study Templates for patient invite letters, GP letters Letters of approval CVs of site team Relevant local SOPs Correspondence with sponsor Delegation of duties log Modifications to documents need REC approval before use

22 During the delivery of the study Maintaining site file Secure storage Maintenance and storage of patient level documentation Delivering study in accordance with study protocol Reporting process Reporting of adverse events Duties can be delegated

23 Delegation of duties PI can delegate activities in the protocol

24 PIC sites PIC = Participant Identification Centre Identification of participants who then are put in touch with study team at a study site No consent or procedures at the PIC site No benefit in terms of R&D targets Can help to foster research active environment People can also access studies at other sites via Join Dementia Research (JDR)

25 Survey of North Thames consultant psychiatrists research activity June 2015 NELFT, ELFT, C&I, BEH 130 responses

26 Time dedicated to research in job plan?

27 Time per week engaged in research activity

28 Time willing to dedicate to research informally

29 Other survey findings 81% agreed that research should be part of day to day clinical practice 80% agreed that they wanted to be involved in clinical research 59% agreed they would know how to go about getting involved 55% agreed that they understood what being a PI would involve 10% agreed that they had time for research within day to day clinical work

30 So can I take on a role as a PI? Dementia and Physical Activity Study (DAPA) 16 week RCT of exercise in dementia Delivered by NELFT physiotherapists with backfill for their clinical time Lead physiotherapist was PI Supported by R&D dept including research assistants Legacy: BrainFit

31 Objectives Primary objective: RCT to estimate the effects of an exercise/physical activity intervention that is feasible for delivery within the current constraints of National Health Service delivery. Secondary objectives were to: Complete a parallel cost study and conduct an economic analysis from a healthcare and societal perspective. Investigate intervention effects in pre-defined subgroups of gender and dementia severity.

32 Outcome Measures MMSE Bristol Activity of Daily Living scale Other outcomes included - Euro-QoL, EQ-5D, QoL, NPI, Mood - Cornell Scale for Depression in Dementia, Zarit Burden Interview

33 Inclusion criteria 1.Dementia 2.MMSE >10 3.Able to participate in a structured exercise programme: a) able to sit on a chair and to walk 10 feet without human assistance; b) no serious unstable illness (e.g. unstable angina) 4. Live in the community

34 Intervention Initial pre-assessment 1 x hour sessions of physiotherapy twice a week 30 minutes aerobic 30 minutes resistance Follow up telephone calls 16 week duration

35 Delivery Harold Hill Health Centre Equipment Training Supervision Transport Backfill costs

36 Recruitment Referrals from Memory Clinics, CST groups, Community Health services Screening (telephone), baseline, 6 months and 12 months 728 participants 364 Intervention 364 TAU 6 NELFT 6 NELFT Carers were included, so recruitment targets doubled Success of first group led to a second intervention group

37 Reflections - benefits 1.Increased research knowledge and experience with the clinical team 2.Developed relationships between Mental Health and Community Health Services 3.Increased skills of physiotherapists in working with people with dementia and their carers 4.Staff trained and assessed in use of wide range of measures 5.Participant feedback was very positive 6.Backfill payments to invest in additional resource 7.Carers involvement in supporting the intervention and networking 8.Legacy - BrainFit

38 Reflections - challenges 1.Managing expectations of participants when the groups finished 2.Time expectations 3.Meeting the demands of a busy service 4.Staffing changes and resources 5.Wanting to provide additional input adherence to intervention protocol 6.Managing expectations of those participants who were allocated to the control group 7.Identifying people with dementia interested in exercising using a bicycle 8.Unblinding of researchers

39 So can I take on a role as a PI? INVEST study Individual CST in Parkinson s disease dementia JR PI as oversight Delivery of study by R&D staff

40 So can I take on a role as a PI? Role varies a great deal between studies, many responsibilities can be delegated in some cases If interested it is worth speaking to Your own R&D dept CRN about studies that are potentially open to sites Support/resource may be available from R&D or CRN There are a lot of acronyms and regulatory systems More intense with more risk associated with the study Don t be put off others can help you navigate Speak to your R&D before agreeing to PI a study!