Both nationally and internationally, the assessment of outcomes based on the patient’s perspective using patient-reported outcome (PRO) measures, are increasingly accompanying the traditional clinical ways of measuring health and the effects of treatment on the patient.
Data derived from PROs provides added value in supporting key biomedical endpoints, reimbursement, product differentiation and marketing. However, many questions remain such as what is achievable using a PRO? How can we distinguish between the different measured endpoints? How can we understand a PRO score in relation to clinical endpoints? And most importantly, how do we get key stakeholders to pay for their inclusion in clinical trials and observational studies?
In recent years, the US Federal Drugs Administration (FDA) has become more critical of instruments used to measure patient-reported outcomes (PROs) in clinical trials.This one day workshop which has been designed for participants involved in the selection and application of PROs, focuses on describing both the recommended development of a PRO measure and the psychometric properties as well as the evidence which must be presented if the measure is to support regulatory approval or promotional claims.
- Quality of life versus health status: PROs are often selected on the basis of their popularity. To ensure your data is not misinterpreted and conclusions flawed through inappropriate PRO selection, we help you to distinguish between the different PRO endpoints e.g. does the EQ-5D and SF-36 measure QoL or health status?
- 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 you to identify the relevant PRO to demonstrate potential treatment effects.
- Selecting the appropriate PRO: We explore the range of evidence required to support the selection of a PRO, including content validity and other psychometric properties of the instrument.
- FDA versus EMEA Guidance: We will illustrate the similarities and differences between the FDA and EMEA guidance and the implications of these when selecting a PRO and interpreting PRO data.
Who Should Attend?
This workshop is suitable for clinical trialists, researchers, healthcare professionals and others who require a greater and more practical understanding in the development, evaluation and selection of PROs and the evidence to be presented if the measure is to support regulatory approval or promotional claims.
Key Learning Outcomes
At the end of the workshop you will be able to:
- Understand the recommended developmental process of a PRO and the required evidence for selecting an appropriate PRO
- Review and evaluate existing, modified or newly developed PRO instruments to support drug approvals and product labeling
- Appreciate the importance of developing a secondary endpoint model for selecting the appropriate PRO and assuring relevant outcomes are measured
- Appreciate the similarities and differences between the FDA and EMEA guidance and their implications when selecting a PRO to support regulatory approval or promotional claims.
What else is included in the workshop?
- An interactive training session providing opportunities for discussion and debate
- Comprehensive take away training pack
- Limited email follow-up support
Cost and booking
£275+20%VAT. Cost includes light refreshments
The workshop will be limited to 12 participants
To book contact: firstname.lastname@example.org
Tel: +44 (0)1295 724233
Bloxham Mill Business Centre
Barford Road, Bloxham
Wednesday 5th June 2013
09.30 – 16.00
We can customise this courses to your specific objectives or design a new course specifically to match your requirements. For more information email: email@example.com
Choose from one of our scheduled training courses that will help you achieve your goals.
Developed to support clinicians, commissioners and providers, managers, health professionals and researchers our Standard Scheduled Training Programme provides a range of training including, courses in Cognitive Interviewing, Discovery Interviewing, Patient Reported Outcome Measures (PROMs), and Questionnaire design.
All our courses are taught by experienced training consultants in a hands-on and relaxed environment and are accompanied by comprehensive course notes and materials.
Our scheduled training courses are held at our Bloxham Mill Business Centre Offices, Banbury, Oxfordshire, but can be delivered at a venue and time convenient to your organisation providing 6 or more delegated are registered.