1. Florence Nightingale Foundation Scholarship: Clinical trials at National Institutes of Health, USA What can we learn from the Americans? Emma Munro Trust Lead Research Nurse Portsmouth Hospitals NHS Trust What can we learn from the Americans? Emma Munro Trust Lead Research Nurse Portsmouth Hospitals NHS Trust

2. Florence Nightingale Foundation Travel Scholarship 2012: Key aims  Compare roles, training and competencies for Clinical Research Nurses in the USA vs UK  Clinical trials delivery: feasibility and recruitment processes  Patient experience and trial promotion  Compare roles, training and competencies for Clinical Research Nurses in the USA vs UK  Clinical trials delivery: feasibility and recruitment processes  Patient experience and trial promotion

3. USA: places visited  Columbia University NYC  National Institutes of Health (NIH) Bethesda, MD  Georgetown University Hospital CRF, Washington DC  Columbia University NYC  National Institutes of Health (NIH) Bethesda, MD  Georgetown University Hospital CRF, Washington DC

4. NIH - Vision & Mission  John Gallin MD, Director of NIH Clinical Centre “patients as partners in research”  President Barack Obama nominated Francis Collins MD, as Director of NIH in 2009 “NIH will pursue efforts to streamline and shorten the pathway from discovery to health”  John Gallin MD, Director of NIH Clinical Centre “patients as partners in research”  President Barack Obama nominated Francis Collins MD, as Director of NIH in 2009 “NIH will pursue efforts to streamline and shorten the pathway from discovery to health”

5. NIH - Vision & Mission Vision: lead the global effort in training today's investigators and discovering tomorrow's cures Mission:  Conducting first in human clinical trials  Excellent patient experience and recruitment  Focus on translational research – bench to bedside  NIH Ethos - what the trial needs the trial gets - protocols subject to scientific review but no need to apply for funding  Training – Multi-disciplinary for current and future generations Vision: lead the global effort in training today's investigators and discovering tomorrow's cures Mission:  Conducting first in human clinical trials  Excellent patient experience and recruitment  Focus on translational research – bench to bedside  NIH Ethos - what the trial needs the trial gets - protocols subject to scientific review but no need to apply for funding  Training – Multi-disciplinary for current and future generations

6. National Institutes of Health  Major centre of academically based research funded federally with a budget of $31 billion. 60 buildings.  Sharing of best practice & training of all disciplines - new curriculum for clinical research training offered globally. 2 day NIH course for CRN’s. Training is awarded 2.5% of total budget.  1440 active clinical research protocols  18000 staff incl. permanent staff of 500 investigators  Major centre of academically based research funded federally with a budget of $31 billion. 60 buildings.  Sharing of best practice & training of all disciplines - new curriculum for clinical research training offered globally. 2 day NIH course for CRN’s. Training is awarded 2.5% of total budget.  1440 active clinical research protocols  18000 staff incl. permanent staff of 500 investigators

7. Clinical trials delivery: Feasibility at trial design stage  All protocols reviewed by the Scientific Review Committee (SRC) at the time of initial submission and then every three years.  External reviews as required by protocol i.e. FDA  All open protocols must also be reviewed at least once a year by the Institutional Review Board  NIH Office of Protocol Services obtains necessary approvals  Training programmes for new investigators on ethical and regulatory requirements for conducting research. Investigators must complete before they are permitted to submit protocols for review.  All protocols reviewed by the Scientific Review Committee (SRC) at the time of initial submission and then every three years.  External reviews as required by protocol i.e. FDA  All open protocols must also be reviewed at least once a year by the Institutional Review Board  NIH Office of Protocol Services obtains necessary approvals  Training programmes for new investigators on ethical and regulatory requirements for conducting research. Investigators must complete before they are permitted to submit protocols for review.

8. Patient Recruitment & Public Liaison Office  18 Research nurses & health communication experts assist investigators reach potential participants  Receive 2000 calls per month & emails  Getting the word out - before/after IRB review of protocol, develop and implement strategic recruitment plans, develop materials, and effective dissemination  Involve patient recruitment services at design stage - younger investigators are taking on board the benefits of early involvement  18 Research nurses & health communication experts assist investigators reach potential participants  Receive 2000 calls per month & emails  Getting the word out - before/after IRB review of protocol, develop and implement strategic recruitment plans, develop materials, and effective dissemination  Involve patient recruitment services at design stage - younger investigators are taking on board the benefits of early involvement

9. Patient Recruitment & Public Liaison Office, NIH  Plan rescue recruitment strategies at design stage  Recruitment funnel - of those who pass initial screening total enrollment averages 10% of those referred  The office contrasts & compares their target assessment figure with CI assessment of potential target  Critical first step - telephone pre-screening of eligibility criteria  Plan rescue recruitment strategies at design stage  Recruitment funnel - of those who pass initial screening total enrollment averages 10% of those referred  The office contrasts & compares their target assessment figure with CI assessment of potential target  Critical first step - telephone pre-screening of eligibility criteria

10. Patient experience & trial promotion  Concern for every research volunteer is linked to successful conduct of clinical trials  Safra Family Lodge – “illness affects whole family not just individual”  Childrens Inn & Sibling School  Recreation therapy schedule 1000-1800, gym, library, IT centre, yoga, art etc  Concern for every research volunteer is linked to successful conduct of clinical trials  Safra Family Lodge – “illness affects whole family not just individual”  Childrens Inn & Sibling School  Recreation therapy schedule 1000-1800, gym, library, IT centre, yoga, art etc

11. Clinical trial promotion  Recruitment office send referral letter to callers to share with referring health care provider  Physician referrers routinely mailed trial updates and new trials  Run a volunteer programme  NIH website  Patient awareness campaigns, monthly magazines – NIH MedlinePlus  Newsletter to patients on trials, birthday cards AND…  Recruitment office send referral letter to callers to share with referring health care provider  Physician referrers routinely mailed trial updates and new trials  Run a volunteer programme  NIH website  Patient awareness campaigns, monthly magazines – NIH MedlinePlus  Newsletter to patients on trials, birthday cards AND…

12.  National registry connecting potential participants with researchers. 2/52 = 7 new studies & 300 new volunteers  Funded through NIH translational research programme  Individuals enter details  National registry connecting potential participants with researchers. 2/52 = 7 new studies & 300 new volunteers  Funded through NIH translational research programme  Individuals enter details Researchmatch!

13.  Investigators access how many people could be eligible using non-identifiable data emails potential participants  Investigators also now enter information of upcoming trials to gauge likely recruitment  Investigators access how many people could be eligible using non-identifiable data emails potential participants  Investigators also now enter information of upcoming trials to gauge likely recruitment

14. Lessons learnt from the Americans at PHT  New protocol writing group of CRN’s to increase involvement at design stage  Link to NIH Chief Nurse office to roll out NIH phase 2 nurse-led trials  NIH recognise higher level programs of study do not meet practical training issues of a CRN’s job – 2 day CRN course offered for adoption and adaption  SW CLRN Managers support 11 lead research nurses to develop CRN 2 day course and roll out a pilot. Thanks to Rebecca at HIOW & Peninsula and SW.  Patient Recruitment Office – Director of Research supports plans to develop at PHT  New protocol writing group of CRN’s to increase involvement at design stage  Link to NIH Chief Nurse office to roll out NIH phase 2 nurse-led trials  NIH recognise higher level programs of study do not meet practical training issues of a CRN’s job – 2 day CRN course offered for adoption and adaption  SW CLRN Managers support 11 lead research nurses to develop CRN 2 day course and roll out a pilot. Thanks to Rebecca at HIOW & Peninsula and SW.  Patient Recruitment Office – Director of Research supports plans to develop at PHT

15. Promoting clinical trials: all the fun’s in how you say a thing!

16. International Clinical Trials Day Banner! Amazing things are happening here www.ukctg.nihr.ac.uk

17. With thanks to the Florence Nightingale Foundation for awarding me a 2012 Travel Scholarship And a huge thanks to Clare Hastings, Chief Nurse & Cheryl Fisher, Programme Director, NIH Clinical Centre, and to my boss Prof Chauhan for letting me go! Thank you for listening And a huge thanks to Clare Hastings, Chief Nurse & Cheryl Fisher, Programme Director, NIH Clinical Centre, and to my boss Prof Chauhan for letting me go! Thank you for listening