Florence Nightingale Foundation Scholarship: Clinical trials at National Institutes of Health,USA What can welearn from theAmericans? Emma Munro Trust Lead Research Nurse Portsmouth Hospitals NHS Trust
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
USA: places visited • Columbia University NYC • National Institutes of Health (NIH) Bethesda, MD • Georgetown University Hospital CRF, Washington DC
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”
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
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 National Institutes of Health
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.
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
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
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
Clinicaltrial 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 – NIHMedlinePlus • Newsletter to patients on trials, birthday cards AND…
Researchmatch! • 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! • 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 fromthe Americans atPHT • 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
Amazing things are happening here www.ukctg.nihr.ac.uk International Clinical Trials Day Banner!
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