Florence Nightingale Foundation Scholarship: Clinical trials at National Institutes of Health, USA What can we learn from the Americans? Emma Munro Trust.

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