1. Selecting the Appropriate
PRO for your Clinical Trial
Wednesday 5th June 2013 Bloxham Mill Business Centre, Banbury, Oxfordshire
Information derived from PROs provides added value Key Learning Outcomes
in supporting key biomedical endpoints,
At the end of the workshop you will be able to:
reimbursement, product differentiation and
marketing. However, many questions remain such as • Differentiate between of health status, QoL and HRQoL
what is achievable using a PRO? How can we • Understand the recommended developmental process of a PRO and the required
evidence for selecting an appropriate instrument
distinguish between the different measured
endpoints? How can we understand a PRO score in • Review and evaluate existing, modified or newly developed PRO instruments to
support drug approvals and product labelling
relation to clinical endpoints? And most importantly,
how do we get key stakeholders to pay for their • Appreciate the importance of developing a secondary endpoint model for
selecting the appropriate PRO and assuring relevant outcomes are measured
inclusion in clinical trials and observational studies?
• Appreciate the similarities and differences between the FDA and EMA guidance
This one day workshop which has been designed for participants and their implications when selecting a PRO to support regulatory approval or
promotional claims
involved in the selection and application of PROs, focuses on
describing both the recommended development of a PRO measure • Demonstrate the benefits of patient-perceived effects as a valuable adjunct to
indicators of medical efficacy in clinical trials and observational studies
and the psychometric properties as well as the evidence which must
• Determine if paper or electronic PRO (ePRO) should be used. If using ePRO,
be presented if the measure is to support regulatory approval or decide which device is best suited for your protocol.
promotional claims.
Visit our website www.dhpresearch.com or tel: 44 (0) 1295 724233

2. Selecting the Appropriate
PRO for your Clinical Trial
Wednesday 5th June 2013 Bloxham Mill Business Centre, Banbury, Oxfordshire
Course Outline Who Should Attend?
This workshop is suitable for clinical trialists, researchers, healthcare professionals and
• Quality of life versus health status: To ensure your data is not
misinterpreted and conclusions flawed through inappropriate PRO others who require a greater and more practical understanding in the development,
selection, we help you to distinguish between the different PRO
endpoints e.g. does the EQ-5D and SF-36 measure QoL or health evaluation and selection of PROs and the evidence to be presented if the measure is to
status?
support regulatory approval or promotional claims.
• Establishing a secondary endpoint: With emphasis on the
importance of linking the PRO endpoint with the claim, we focus on
the importance of developing secondary endpoint models to enable Cost and booking
you to identify the relevant PRO to demonstrate potential treatment
effects. £275+20%VAT. Cost includes coffee & light lunch , comprehensive take away training
pack and limited email follow-up support
• Selecting the appropriate PRO: We explore the range of
evidence required to support the selection of a PRO, including The workshop will be limited to 12 participants
content validity and other psychometric properties of the instrument.
To book contact: info@dhpresearch.com
• FDA versus EMA Guidance: We will illustrate the similarities and
differences between the FDA and EMA guidance and the implications Tel: +44 (0)1295 724233
of these when selecting a PRO and interpreting PRO data.
• Determine if paper or electronic PRO (ePRO) should be
used. If using ePRO, decide which device is best suited for your
protocol.
Visit our website www.dhpresearch.com or tel: 44 (0) 1295 724233