Crowne Plaza St James Hotel
45-51 Buckingham Gate
London
SW1E 6AF
Tel: +44 (0) 207 834 6655
Fax: +44 (0) 207 6307
www.london.crowneplaza.com
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Conference agenda
Welcome and Introductions
Sandra Chase's experience and qualifications
Purpose of today's workshop
The right patients, the right reasons
Screening for retention success
Documenting behaviour to retain subjects
Advertising for Long-Term Studies
Recruit to retain
Messages that support long-term studies
Professional and community outreach
Recognising patient commitment
Patient recognition items
Welcome and Introductions Patient Recruitment and Retention - the Here and Now
Where does it begin and end?
What is the "norm"?
Establishing what worked and what did not
What Can be Done Differently?
Strategy - do we select the patient or does the patient select the trial?
Tactics vs. deployment
What can be done
Timelines vs. cost
Tactics vs. geography experience (Rx area vs. geography)
Emerging countries
Why go there….and when?
Advantages vs. challenges
DIY or vendor
Costs involved
Chairman's Opening Remarks John Needham, Executive Director and Global Head, Patient Enrolment Strategy, Kendle International Better Protocol Execution Planning Jeffrey Zucker, Manager, Global Trial Optimisation, Clinical Research Operations, Merck
Understanding the impact of inclusion/exclusion criteria and protocol design
Finding the targeted patient
Using data to drive operational planning with assumption based modelling
How to Write Effective Patient Information Materials Theo Raynor, Professor of Pharmacy Practise, University Of Leeds
What are the golden rules for writing good patient information?
Does current clinical trials information meet participants' needs?
How do you involve patients in developing good information materials?
Does better information lead to increased recruitment and retention?
Modernising Patient Recruitment
Does it work outside of the USA?
Work to be done on developing its usefulness and effectiveness
What is the ROI between traditional and electronic recruitment tactics?
What is the proper mix of the two now and in the future?
Staying engaged with patients
Case study: Experiences at Lilly
Brian Schrock, Director of Global Enrollment Optimization, Eli Lilly Greg Stadler, Manager European Medical & Regulatory IT, Eli Lilly Sharon Allin, Global Enrolment Consultant for Europe, Lilly Research Centre Ltd Recruitment Feasibility for Clinical Trials Matt Kibby, Global Operations Leader, BBK Worldwide
Define recruitment feasibility within the broader context of clinical trial feasibility
Engage with a proposed method for determining projected recruitment rate
Walk away with concrete ideas on recruitment feasibility to generate internal company discussion
International Issues: Budgeting and Contracting in Patient Recruitment for Global Clinical Trials Melynda Geurts, Chief Operating Officer, D Anderson & Company
Primary factors
Ancillary areas
Streamlining your approach
Epidemiological Determinants of Successful Patient Recruitment in Poland Pawel Zagozdzon, CEO, ClinPol Research Sp. z o.o.
Higher morbidity in CEEC compared to "old" Europe
Recent trends in the epidemiology of most frequent diseases in CEEC
New screening tools and population based approach
Epidemiology and post-marketing surveillance
Enrolment Feasibility Assessments
Why so few organisations are undertaking effective feasibility studies
Common practices, pitfalls and new approaches
What questions to ask, who to ask and when
The ways to assess the attitude of the study population
John Needham, Executive Director and Global Head, Patient Enrolment Strategy, Kendle International Enhanced Patient Recruitment and Retention Lance Smith, Oncology Established Brands Study Delivery Director, AstraZeneca
What is the basis of recruitment to, or ahead of, plan?
What can we do to ensure best practice is followed?
What measures will tell us whether we have succeeded?
Chairman’s Closing Remarks and Close of Day One Chairman's Opening Remarks Sanjiv Kanwar, Managing Director, Polaris BioPharma Consulting Ltd Allocation of Clinical Trials in CEE Heinrich Klech, Professor of Medicine, CEO and Executive Vice President, Vienna School of Clinical Research
Current status of allocation in CEE - is it a saturated market already?
Quality perspectives
What are the best retention strategies in CEE?
Value of accredited training for selected study centres
Competitiveness to other emerging markets - perspectives for the future
Patient Recruitment and Retention Ralf Kaiser, Regional Head Clinical Monitoring Southern Europe, Merck Sa
What impacts patient recruitment
The ideal set-up
Recruitment and retention strategies
Supporting Recruitment strategies
Case study: implementation of a recruitment strategy in a running trial
Site and Sponsor Partnerships in Clinical Trials
Study validation and site selection
The need for open dialogue and transparency
Study execution considerations in enrolment tactics
Ensuring sufficient personnel resources
Pernilla Sandwall, Business Liaison, Clinical Research Operations, MSD Patient Engagement in Clinical Trials David Collier, Research Fellow in Clinical Pharmacology, Queen Mary, University of London
Why are patients so protected from trials?
How can we change the relationship between those who run trials and patients?
Examples of new ways of engaging patients from the US and UK
Work with the NIHR in UK
Future directions
Getting the Science and Marketing to Mix in Clinical Trial Design to Give a Clear Solution Steve Jadhav, Associate Brand Director (Europe) , Astellas Pharma Europe Ltd
Optimising trials to achieve clinical and commercial objectives
The hazards of getting it wrong
The benefits of getting it right
How and where to publish your results
Cooperation Between Different Parties in Early Development Studies Peter van der Ark, Clinical Research Manager, Johnson & Johnson Pharmaceutical
Background
Complex trial designs and data structures
Co-operation as a solution
How to get the patient into the study
Legal problems
Case study: Early development CNS/rheumatology recruitment
Overcoming Barriers to Paediatric Recruitment and Retention Jane Lamprill, Paediatric Research Consultant, Paediatric Research Consultancy
EU paediatric regulation - no paediatric plan - no MAA!
Paediatric protocol considerations
Effective communication with parents and children
Paediatric patient recruitment strategies
Examples of best practice
Interactive Panel Discussion Open discussion moderated by John Needham John Needham, Executive Director and Global Head, Patient Enrolment Strategy, Kendle International Chairman’s Closing Remarks and Close of Conference
Workshops
Crowne Plaza Hotel - St James 23 March 2010 London, United Kingdom
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