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Florence Nightingale Foundation Scholarship: Clinical trials at National Institutes of Health, USA
Florence Nightingale Foundation Scholarship: Clinical trials at National Institutes of Health, USA
What can we learn from the Americans?
Emma MunroTrust Lead Research Nurse
Portsmouth Hospitals NHS Trust
What can we learn from the Americans?
Emma MunroTrust Lead Research Nurse
Portsmouth Hospitals NHS Trust
Florence Nightingale Foundation Travel Scholarship 2012: Key aims
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
USA: places visited
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
NIH - Vision & MissionNIH - 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”
NIH - Vision & MissionNIH - Vision & Mission
Vision: lead the global effort in training today's investigators and discovering tomorrow's cures
Mission:Conducting first in human clinical trialsExcellent patient experience and recruitment Focus on translational research – bench to bedsideNIH Ethos - what the trial needs the trial gets - protocols subject to scientific review but no need to apply for fundingTraining – 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 trialsExcellent patient experience and recruitment Focus on translational research – bench to bedsideNIH Ethos - what the trial needs the trial gets - protocols subject to scientific review but no need to apply for fundingTraining – Multi-disciplinary for current and future generations
National Institutes of HealthNational 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
Clinical trials delivery: Feasibility at trial design stage
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.
Patient Recruitment & Public Liaison Office
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
Patient Recruitment & Public Liaison Office, NIH
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
Patient experience & trial promotion
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
Clinical trial promotion
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…
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!Researchmatch!
Researchmatch!Researchmatch!
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
Lessons learnt from the Americans at PHT
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
Promoting clinical trials: all the fun’s in how you say a thing! Promoting clinical trials: all the
fun’s in how you say a thing!
International Clinical Trials Day Banner!
International Clinical Trials Day Banner!
Amazing things are happening
here
www.ukctg.nihr.ac.uk
With thanks to the Florence Nightingale Foundation
for awarding me a 2012 Travel Scholarship
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
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