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Accelerating Patient Recruitment and Retention in Clinical Trials
16 April - 17 April 2007
Accelerating Patient Recruitment and Retention in Clinical Trials
Spiralling costs of clinical trials, coupled with an ever-increasing inability to finish a trial on time and on budget makes attendance at the conference compulsory, for you will have the opportunity to hear senior speakers from the world’s leading pharmaceutical companies and CROs present specific presentations on how to attract a greater number of patients onto a trial and how to keep them there once enrolled.

Experience will be shared on how recruitment and retention should differ in paediatric and minority group trials.

The latest web-based technologies will be discussed as experts explain how the internet can improve all aspects of recruitment and retention in clinical trials.

Speakers include:

  • Dr Karen Harmes, Director, Clinical Trials Recruitment, Pfizer
  • Joshua Schultz, Vice President, Patient Recruitment, PAREXEL
  • Professor Vladimir Anisimov, Director, Research Statistics, GlaxoSAE Media GroupthKline
  • Manny Papadimitropoulos, Associate Director, Clinical Research, Eli Lilly*
  • Susan Sandler, Senior Consultant, PAREXEL Consulting
  • Dr Janet Jones, Director, Global Patient Access & Retention, Kendle International
  • Dr Paul Evans, Head, Patient Recruitment UK, Nordics & Baltics, Quintiles
  • Diana Anderson, President & CEO, D. Anderson & Company
  • Dr Ian SAE Media Groupth, Founder and Medical Director, Synexus Clinical Research
  • Dr Alan Wade, Director, CPS Research
  • John Needham, Chief Operating Officer, Patient Recruitment Strategy
  • Jaime Cohen, Strategic and Tactical Specialist, BBK Worldwide
  • Georgi Georgiev, Clinical Research Manager, AstraZeneca Bulgaria

  • EFFECTIVE COUNTRY AND REGION SPECIFIC PATIENT RECRUITMENT AND RETENTION STRATEGIES from leaders in global patient recruitment
  • GROUNDBREAKING NEW TECHNIQUES FOR recruiting from specific populations
  • HOW TO ENHANCE YOUR TRIALS through web-based technologies
  • UNDERSTANDING THE DIFFERENCE in paediatric recruitment
  • RESTORING PUBLIC TRUST in clinical trials
  • EFFECTIVE COUNTRY AND REGION SPECIFIC PATIENT RECRUITMENT AND RETENTION STRATEGIES from leaders in global patient recruitment
  • GROUNDBREAKING NEW TECHNIQUES FOR recruiting from specific populations
  • HOW TO ENHANCE YOUR TRIALS through web-based technologies
  • UNDERSTANDING THE DIFFERENCE in paediatric recruitment
  • RESTORING PUBLIC TRUST in clinical trials
  • *subject to final confirmation

    Conference agenda

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Matt Kibby

    Matt Kibby, Global Operations Leader, BBK Healthcare Inc

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    9:10

    OVERCOMING PATIENT RECRUITMENT CHALLENGES IN GLOBAL CLINICAL TRIALS

    Dr Karen Harmes

    Dr Karen Harmes, Director, Clinical Trials Recruitment, Pfizer Ltd

    ·                 Global study placement drivers
    ·                 Case- study: Patient recruitment planning for multi-national studies- a case study
    ·                 Cultural differences in recruitment messaging
    ·                 Attitudes to research participation
                      Consultants
                      General Physicians
                      Patients
    ·                 Implementation and lessons learned
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    9:50

    ENSURING ON-TIME TRIAL ENROLMENT BY BUILDING IN EARLY INTEGRATION OF PATIENT RECRUITMENT CONSIDERATIONS INTO THE STUDY PLANNING PROCESS

    ·                 Ensuring expectations from the study are realistic
    ·                 Tackling ethical issues and patient concerns
    ·                 Advantages and disadvantages of in-house clinical trials and outsourced trials
    ·                 Management strategies for large volumes of incoming samples and data
    ·                 The rewards and drawbacks of academic collaborations

    Diana Anderson

    Diana Anderson, President , D Anderson & Company

    Dan McDonald

    Dan McDonald, Vice President, D Anderson & Company

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    10:30

    Morning Coffee

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    11:00

    CURRENT CHANGES IN REGULATORY AFFAIRS

    ·                 Manufacturer’s and wholesale dealer’s licences
    ·                 Clinical trials authorisations
    ·                 Surviving inspections of premises and procedures
    ·                 Considering beneficial versus harmful effects in relation to the severity of the diseases

    Susan Sandler

    Susan Sandler, Senior Director, Regulatory Affairs, Clinical Research Services, PAREXEL International

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    11:40

    THE IMPACT OF PROTOCOL DESIGN ON PATIENT RECRUITMENT

    Dr Alan Wade

    Dr Alan Wade, Director and Founder, CPS Research

    ·                 Designing with the patient in mind
    ·                 The quantitative and qualitative data required to accelerate patient recruitment
    ·                 Analysis of clinical trial durations in accordance with therapeutic areas
    ·                 Screening systems for recruitment
    ·                 The chief investigator and responsibilities
    ·                 Impact of changing inclusion and exclusion criteria
    ·                 Extrapolating data from past trials to forecast future ones
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    12:20

    Networking Lunch

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    13:50

    PATIENT RECRUITMENT AT INVESTIGATOR HUB SITES

    Dr Ian Smith

    Dr Ian Smith, Founder and Medical Director, Synexus Ltd

    ·                 Identifying a hub site
    ·                 Confronting the issues for pharma
    ·                 Existing potential solutions
    ·                 Cost issues
    ·                 The hub sites advantages
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    14:30

    UTILISING A RAPID AND EFFICIENT, WEB-BASED STUDY COMMUNICATIONS INFRASTRUCTURE

    ·          The expansion of web-based healthcare communications in Europe and the U.S.
    ·          Identifying and selecting sites through web-based tools
    ·          Understanding the importance of data integration for rapid resource allocation and redeployment decisions
    ·          Training and consulting with sites through the internet
    ·          Cutting-edge techniques for internet-based physician and consumer outreach

    Jaime Cohen

    Jaime Cohen, Strategic and Tactical Specialist, BBK Worldwide

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    15:10

    Afternoon Tea

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    15:40

    PATIENT RECRUITMENT PREDICTION

    Vladimir Anisimov

    Vladimir Anisimov, Director, Research Statistics Unit, GlaxoSmithKline

  • Uncertainties in patient recruitment
  • Recruitment modeling
  • Model validation using historical data
  • Predicting recruitment (initial and intermediate stages)
  • Examples of real studies
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    16:20

    Chairman’s Closing Remarks and Close of Day One

    Matt Kibby

    Matt Kibby, Global Operations Leader, BBK Healthcare Inc

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Matt Kibby

    Matt Kibby, Global Operations Leader, BBK Healthcare Inc

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    9:10

    PREDICTIVE PLANNING AND CONTINGENCY-BASED ESCALATION FOR RECRUITMENT SUCCESS

    ·                 Using sophisticated recruitment modelling tools in planning
    ·                 Building and applying investigator intelligence data assets
    ·                 Leveraging historical data to create reliable feasibility estimates
    ·                 Building organizational structures that support recruitment across the development spectrum (e.g. feasibility, site selection, study start-up and patient outreach)
    ·                 Using an explicit process of contingency-based escalation to manage changes in the environment

    Joshua Schultz

    Joshua Schultz, Vice President, PAREXEL International

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    9:50

    RETENTION OF PATIENTS IN CLINICAL TRIALS

    Dr John Needham

    Dr John Needham, Chief Operating Officer, Patient Recruitment Strategy, LLC

    ·                 Creating and communicating the study’s value proposition to patients
    ·                 Providing positive reinforcement at every visit
    ·                 Acquiring and utilising educational/support study materials for patients and their families
    ·                 Comparing incentives, what patients say they need and what will an Ethic Committee allow?
    ·                 Improving listening skills for site staff
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    10:30

    Morning Coffee

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    11:00

    CASE STUDY- GLOBAL STRATEGIC AND TACTICAL CONSIDERATIONS OF PAEDIATRIC RECRUITMENT AND RETENTION

    Dr Janet Jones

    Dr Janet Jones, Director, Global Patient Access and Retention , Kendle

    ·                 Ethical and scientific aspects of paediatric recruitment
    ·                 Designing studies with the child in mind, the pitfalls of applying adult approaches to the paediatric population
    ·                 Global feasibility and planning: country specific, therapeutic and age related considerations
    ·                 Paediatric site profiles
    ·                 Gaining informed consent and assent
    ·                 Child and family friendly materials and approaches to support paediatric recruitment and retention
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    11:40

    PANEL DISCUSSION- DIFFERING REGULATORY AND CULTURAL ISSUES THAT IMPACT PATIENT RECRUITMENT AROUND THE WORLD

  • The USA
  • CEE
  • Latin America
  • India
  • Matt Kibby

    Matt Kibby, Global Operations Leader, BBK Healthcare Inc

    Joshua Schultz

    Joshua Schultz, Vice President, PAREXEL International

    Dr Janet Jones

    Dr Janet Jones, Director, Global Patient Access and Retention , Kendle

    Diana Anderson

    Diana Anderson, President , D Anderson & Company

    Georgi Georgiev

    Georgi Georgiev, Manager, Clinical Research, AstraZeneca Bulgaria

    Dan McDonald

    Dan McDonald, Vice President, D Anderson & Company

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    12:40

    Networking Lunch

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    14:10

    PATIENT RECRUITMENT, A UK FOCUS

    Dr Paul Evans

    Dr Paul Evans, Head, Patient Recruitment, UK, Nordics & Baltics, Quintiles Ltd

    ·                 The patient availability and marketing potential within the UK
    ·                 Perspectives and trends in today’s climate
    ·                 Barriers to successful recruitment in the UK
    ·                 The impact of NHS changes on the clinical trials environment
    ·                 Strategies to overcome slow recruitment
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    14:50

    THE ADVANTAGES OF CONDUCTING CLINICAL STUDIES IN CENTRAL AND EASTERN EUROPE

    Georgi Georgiev

    Georgi Georgiev, Manager, Clinical Research, AstraZeneca Bulgaria

    ·          Determining the location of investigational sites in a global market

    ·          Patient population, recruiting twice as fast as Western counterparts

    ·          Patient motivation

    ·          Regulatory issues in Central and Eastern Europe

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    15:30

    Afternoon Tea

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    15:30

    Chairman’s Closing Remarks and Close of Conference

    Matt Kibby

    Matt Kibby, Global Operations Leader, BBK Healthcare Inc

    Workshops

    Effective Marketing and PR Strategies for Patient Recruitment in Clinical Trials
    Workshop

    Effective Marketing and PR Strategies for Patient Recruitment in Clinical Trials

    Crowne Plaza Hotel - The City
    18 April 2007
    London, United Kingdom

    Crowne Plaza Hotel - The City

    19 New Bridge Street
    London EC4V 6DB
    United Kingdom

    Crowne Plaza Hotel - The City

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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, SAE Media 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@saemediagroup.com

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