Principle Investigator Training

Transcription

1 Principle Investigator Training January 2015, Southampton Dr Waquas Waheed CRN and The University of Manchester

2 Outline Introduction to clinical trials in the UK Role of the networks Role of CSO Role of the research nurse Setting up a site: feasibility Working with a PI.case studies How to get involved

3 Clinicians participation in RCTs: Advantages for Clinicians Chance to collaborate with other clinical investigators Bring a research culture into the clinic setting Offer patient a chance of new therapy Be on the leading edge of therapy innovation

4 Role of NIHR CRN

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6 Our Mission Statement To facilitate research & Increase research opportunities for patients, and improve NHS

7 The Clinical Research Network comprises of 15 Local Clinical Research Networks 30 clinical specialties

8 Key statistics for 2013/14: 600,000 patients recruited in 2013/14. 3 million patients recruited in the last six years. 96,000 patients recruited to commercial studies. 99 % Trusts recruiting patients onto NIHR CRN Portfolio 86% of Trusts recruit onto NIHR CRN commercial studies 1,477 new clinical studies last year 533 new commercial studies, a 17% increase

9 To be considered for Clinical Research Network support a study must: Be a research study This is defined by the DoH as the attempt to derive generalisable (i.e. of value to others in a similar situation) new knowledge by addressing clearly defined questions with systematic and rigorous methods Have full research funding Study Funders (companies, institutions or organisations) determine the route through which a study is considered for Clinical Research Network support

10 Automatically eligible Potentially eligible Not eligible

11 Role of a Clinical Studies Officer (CSO)

12 CSOs are involved in Feasibility Study set up Screening & recruitment Study coordinator Rater

13 The Role of the Research Nurse

14 Setting up new site Assist Feasibility Form completion Attend Site selection Visit Attend Site Investigator Meeting/Training Attend site Initiation visit Develop recruitment plan with regular review

15 Screening Tasks Preparation of Case report Forms & study docs Book Taxi s for patient Perform ECG Take Blood Spin Blood / Order courier Record Vital signs Height, Weight, BP, HR Cognitive assessments - separate room Data entry onto electronic database

16 Becoming an active clinical trials site: Feasibility

17 PI Tasks: Before the study begins Getting an invitation to submit a feasibility assessment Evaluating the study protocol Completing a realistic feasibility assessment Informing your R&D department What resources do you need?

18 PI Tasks: Before the study begins 10 sections in ICH GCP compliant protocol Evaluating the study protocol 1. general information 2. background 3. Objective 4. Trial design/methodology 5. Patient selection 6. Treatment regimen 7. Assessments for efficacy 8. Assessments for safety 9. Data and statistics 10. Other information

19 Things to consider when assessing a new study protocol Purpose of the research Procedure Benefits and risks Why is this study/trial being conducted? What do the researchers hope to discover? What is involved (e.g. hospital stays, visits to doctor, injections, blood tests and scans etc.)? Is any of this likely to be stressful, uncomfortable, burdensome or painful? What is the likelihood that I will receive the experimental drug (in the case of clinical trials)? How long will the study/trial last? Where will I have to go and how often? Are there any benefits or risks involved in this study/trial? Am I likely to personally benefit from participating in this study/trial? What are my treatment or care options if I decide not to participate in this study/trial?

20 Continuing care Safety Confidentiali ty Payment Restrictions How will participation in this study/trial affect my current care? How will participation in this study/trial affect my future care? What are the likely side effects? What will happen if I suffer side effects? If anything goes wrong, would I be covered by some kind of insurance? Who is responsible for the safety and wellbeing of participants? Whom can I contact in case of emergency or if I wish to complain? Who will be informed that I am participating in this study/trial? Who will know whether I am receiving the experimental drug? Will personal information about me be kept on a computer or in a report? If so, will my anonymity be respected? Would I be bound to secrecy in any way? How will the results of the study be presented and used? Will I be informed of the results of the study afterwards? Is there any payment to compensate participants for their time and travel? Does anyone receive compensation of any kind for my participation in the study/trial? Is there anything I should or shouldn t do during the study/trial? Can I also take authorised drugs for dementia during the study/trial?

21 PI Tasks: Before the study begins Completing a realistic feasibility assessment Allows the Sponsor to determine whether the study can be successfully run at your site (cost 50K per site!) Patient numbers and sources of patients Recruitments methods (past examples) Protocol issues that are tricky Analysis of resources Make up of team..raters!

22 Performance Metrics: Department of Health NIHR requirement Must not exceed 70 days from submission of a valid application to an NHS Trust to consent of first patient (First Patient First Visit - FPFV). So the 70 day period involves governance reviews and approval by the Trust, screening and contacting potential patients by the PI and research team, and the first appointment to take written consent from a participant.

23 Study set up targets involve R&D departments and other support depts. (e.g. pharmacy, radiology etc) as early as possible in the set up of a study to ensure this is as quick and smoothe as possible. Study set up can sometimes be competitive - companies may for example identify 12 study sites, and work with the 10 who can set the study up the quickest -

24 Recruitment Targets Sponsors will be assessing sites on recruitment to time and target = for a CTIMP, this means numbers successfully screened and randomised - not just consented. often competitive and worldwide so if some countries/sites recruit quickly, recruitment could close and your site could lose out.

25 Commercial sponsor requirements (pharma industry): Feasibility stage - submit feasibility questionnaires / expressions of interest within timeframes set by the company or the local research network (e.g. DeNDRoN).

26 Repeat Business if the above goes smoothly and successfully, companies will want to work with sites again. If there are delays with questionnaires etc in the early stages this is not a good sign to the sponsor. Identify any potential issues early on and the sponsor will work with you to resolve them.

27 PI Tasks: Before the study begins Resources needed: Raters, co-pi, sub-investigators Pharmacy neuroimaging rooms! Storage space Online access Space for monitor visits Phone lines for ECGs Specialist services (LPs, neurology, ophthalmology, dermatology, respiratory)

28 PI Tasks: Before the study begins Getting approvals: Discuss with your clinical director What kind (and when) of notifications do the R&D dept. require Negotiate what your cut will be Who will support you and how trial work will fit in with current job plans

29 Site Selection Visits Meet with site selector +/- monitor Team introductions Discuss protocol and potential challenges Recruitment targets Address questions about recruitment targets and strategies, ability to do the ratings, type of service, inclusion/exclusions Facilities Visit to facilities (pharmacy, imaging, R&D..)

30 How we work with Principal Investigator Case studies

31 Case study - Commercial Trial RCT 123 Identify appropriate NHS sites Assist with approval process Costing template Review recruitment strategies Data collection / patient schedules Assist monitoring visit Finance Patient transport

32 Non- Commercial Trial Development of a synuclein as a potential molecular marker for Parkinson Disease Design of protocol Assist funding application Set up multiple sites Devised Case report forms Ethics annual reports Data collection/patient visits Monitoring Analysis of data

33 Research next steps

34 GCP training PIC site Shadowing / Co-Investigator Become a Rater Apply for studies (feasibility)

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