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It is widely accepted that patient recruitment is the rate-limiting step of any clinical trial. With an estimated $0.6 million to $8 million loss in revenue for each day the drug is delayed, more focus must be placed on the acceleration of patient recruitment. As more regulations are enforced onto the pharmaceutical industry, an ever-increasing number outsource trials. To stay ahead in a competitive market, changes must be continually made to develop present strategies in order to streamline current patient recruitment procedures.

SMi’s 2nd Annual conference on ‘The Acceleration of Patient Recruitment in Clinical Trials’ will provide a forum where past, present and future recruitment strategies and developments can be discussed on a global level. Examining the qualitative and quantitative data required, see how the top pharma, biotech, CRO’s, SMO’s and patient recruitment organisations combine the key clinical elements in order to efficiently recruit patients and conduct clinical trials. Addressing site identification, management and legislation issues, listen to new ideas and strategies aimed at recruiting the right patients and retaining them throughout investigation based on patient opinions, needs and experiences.

Conference programme

8:30 Registration & Coffee

9:00 Chairperson's Opening Remarks

John Needham

John Needham, Chief Operating Officer, Patient Recruitment Strategy

9:10 ACCELERATING PATIENT RECRUITMENT

Karen Foley

Karen Foley, Senior Director, Clinical Operations, Eisai Global Clinical Development, Eisai

  • The expanding role of patients in clinical trials
  • Ethical issues - overcoming the difficulties of getting consent
  • The development and management of study plans, phases and data analysis
  • Identification and targeting of appropriate populations
  • Organising multi-centre trials
  • Past, current and future recruitment strategies – the pitfalls and successes
  • 9:50 PUBLIC PERCEPTIONS OF CLINICAL RESERACH STUDIES

    Rowena Dickerson

    Rowena Dickerson, Senior Communications Director, Fast4wD Ogilvy

  • The public perception of clinical trials
  • Methods of public communication and public preferences
  • What are the influential factors and decisions that affect participation rates and how do these differ globally?
  • Reasons for patient participation and the perceived risks and benefits
  • Views on informed consent
  • Online clinical registries
  • Future considerations for patient communication when planning global clinical trials
  • 10:30 Morning Coffee

    11:00 MASLOW'S HIERACHY OF NEEDS AND CLINICAL TRIAL PARTICIPATION

    John Needham

    John Needham, Chief Operating Officer, Patient Recruitment Strategy

  • The steps sponsors, CROs, patient recruitment service providers and site staff need to take
  • The results of recent participation surveys indicating participants greatest needs during a study and those traditionally unmet by sites
  • A ‘check list’ to help assess the challenges a study may present for a participant
  • A list of organisations skilled in global patient needs assessment
  • Examples of patient education materials which have been used to help potential participants overcome barriers to study participation
  • The value of needs assessments and developing solutions to address them
  • 11:40 ACCELERATING THE PATIENT RECRUITMENT PROCESS

    Simon Chapman

    Simon Chapman, Chairman, The Essentia Group

  • Key challenges within patient recruitment campaigns
  • Response technologies – what currently exists and practical applications?
  • Managing response in a timely and cost effective manner
  • Some key stats
  • 12:20 Networking Lunch

    13:50 GETTING THE MESSAGE RIGHT. STRATEGIC AND TACTICAL APPLICATION OF MARKETING PRACTICES TO THE LINICAL TRIAL ARENA

  • Strategic planning to define the patient access approach
  • Understanding and defining the market environment
  • Developing the right messages
  • Local implementation in mixed cultural environments
  • Practical approaches to define and overcome patient recruitment barriers
  • CRA evolution
  • Janet Jones

    Janet Jones, Global Director Business Support, Kendle

    Kate Spencer

    Kate Spencer, Account Director, Langland

    14:30 GLOBAL PATIENT RECRUITMENT

    Beth Harper

    Beth Harper, Vice President, D Anderson & Company

  • Planning and managing global recruitment campaigns – practical experience in over 25 countries
  • What are the challenges and opportunities for global patient recruitment programmes?
  • How do different countries approach patient recruitment?
  • What can and can’t be done in different regions from a cultural and regulatory point of view?
  • How have various strategies been implemented and received by global audiences?

  • 15:10 Afternoon Tea

    15:40 OPERATIONAL AND LEGISLATIVE ASPECTS OF PEADIATRIC RECRUITMENT FOR CLINICAL TRIALS

    Richard Tiner

    Richard Tiner, Medical Director, Association of the British Pharmaceutical Industry (ABPI)

  • The scientific and practical aspects of paediatric recruitment
  • Why data from adult studies cannot be extrapolated for use in the paediatric population
  • Age related differences that exist in physiology, pathology, pharmacokinetics and pharmacodynamics
  • Ethical and practical issues affecting clinical trials in children and the elderly
  • How to retain patients by improving staff-family relationships
  • The legal framework to facilitate paediatric drug development
  • 16:20 RETENTION OF PATIENTS IN CLINICAL TRIALS

    Jim Kremidas

    Jim Kremidas, Global Enrolment Optimisation , Eli Lilly

  • Effective marketing – raising public awareness
  • Production of educational/support study materials for patients and investigators
  • Improving motivation and communication between patients and staff
  • Showing appreciation to clinical study volunteers
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairperson's Opening Remarks

    Beth Harper

    Beth Harper, Vice President, D Anderson & Company

    9:10 SITE SELECTION

    Sue  Tempest

    Sue Tempest, Site implementation and Training Manager, Merck Research Laboratories

  • Finding the best locations to suit your needs
  • Strategies to evaluate site and resource requirements
  • On-site pre- and post-trial monitoring
  • Site training
  • Performance metrics
  • 9:50 INVESTIGATOR SITE NETWORKS IN CONTINENTAL EUROPE

    Hans-Detlev Stahl

    Hans-Detlev Stahl, Chief Executive Officer, Clinpharm

  • Databanks of "patients interested in clinical trials"
  • Pre-screening
  • Advertisement
  • Networks of private doctors
  • Monitoring of enrolment rates
  • 10:30 Morning Coffee

    10:50 IMPLEMENTING AND DRIVING SUCCESS OF INTERNATIONAL PATIENT RECRUITMENT AND RETENTION STRATEGIES THROUGH THE CONVENTIONAL CLINICAL RESEARCH PROCESS AT THE INVESTIGATIVE SITE

    Tom Ruane

    Tom Ruane, Director, Patient Recuitment, Quintiles (UK) Ltd

  • Cultural and logistical challenges of advertising/study awareness in a clinical trial setting
  • Who actually ‘recruits’ the patient - does it differ by region?
  • Is it just advertising or is there more involved? - Partnership with sites
  • Bridging the marketing and clinical mindsets at the CRA and clinic level
  • Ethics and regulatory observations on patient recruitment and retention strategies
  • The 'golden age' of TV, radio, call-centre and internet and the part of 'conventional' media in helping recruit patients
  • What are the meaningful metrics and how can they be measured?
  • 11:30 COUNTRY STUDY MANAGERS

    Jamie Cohen

    Jamie Cohen, Enrolment Manager, BBK Healthcare Inc

  • A close look at the CSM’s complex and valuable contributions
  • Understanding the CSM’s roles and responsibilities
  • CSM’s perspective on recruitment and site relations
  • Examining the CSM’s needs and requirements
  • Strategies for improving efficiencies
  • 12:10 THE ROLE OF THE REGULATOR

    Malcolm Barratt-Johnson

    Malcolm Barratt-Johnson, Medical Assessor, Clinical Trials Unit, Medicines & Healthcare products Regulatory Agency (MHRA)

  • How did we get here?
  • The Clinical Trial Directive (CTD) in practice
  • The role of the competent authority
  • Pharmacovigilance in the wake of the CTD
  • Where to from here?
  • 12:50 Networking Lunch

    14:20 METHODS AND METRICS FOR PATIENT RECRUITMENT AGAINST PROTOCOL DESIGN

    Alan Wade

    Alan Wade, Director, CPS Research

  • Protocol design and its impact on recruitment
  • Does past performance indicate future success?
  • Recruitment methodology vs therapeutic area
  • Patient sources
  • Centre assessment
  • Feasibility assessments – when, how and for whom?
  • 15:00 CANDIDATE QUALIFICATIONS AND MEASUREMENT OF CAMPAIGN PERFORMANCE METRICS

    Bill Byrom

    Bill Byrom, Product Strategy Director, ClinPhone Group Ltd

  • Case studies in the use of IVR and web qualification screeners to qualify trial candidates
  • Using validated computerised assessments to measure disease severity
  • When to use an automated system, and when to use a call centre
  • How other eClinical technologies involved in the trial can facilitate reporting of recruitment campaign performance metrics
  • 15:40 Afternoon Tea

    16:00 RECRUITING ADULTS WITH NORMAL LIPID BUT ELEVATED CRP LEVELS

    Ian Smith

    Ian Smith, Medical Director, Synexus Ltd

  • Overview of study
  • Recruitment methods
  • Opportunistic, cost effective methods of recruitment by consultants and GP’s
  • Responses and costs
  • Review of costs for sponsor
  • Conclusion
  • 16:40 PATIENT RECRUITMENT BEST PRACTICES AMOUNG TOP PHARMACOS

    Donald Greene

    Donald Greene, Director of Marketing & Sales, Veritas Medicine, Inc.

  • Overall on time performance record and speed of accrual rates
  • Performance metrics by therapeutic area
  • Protocol planning
  • PT evaluation and selection
  • Site contracting
  • IRB selection and contracting
  • Patient Recruitment, planning methods and tactics
  • Management strategies
  • 17:20 Chairman’s Closing Remarks and Close of Day One

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    Workshops

    Clinical trial Project Management - Achieving Success in a Complex Organisation (AM)
    Workshop

    Clinical trial Project Management - Achieving Success in a Complex Organisation (AM)

    Millennium Gloucester Hotel
    29th March 2006
    London, United Kingdom

    Notes from Industry - Enrolment Intelligence to Achieve Superior On-Time Results (PM)
    Workshop

    Notes from Industry - Enrolment Intelligence to Achieve Superior On-Time Results (PM)

    Millennium Gloucester Hotel
    29th March 2006
    London, United Kingdom

    Millennium Gloucester Hotel

    Harrington Gardens
    London SW7 4LH
    United Kingdom

    Millennium Gloucester Hotel

    HOTEL BOOKING FORM

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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