Selecting the Appropriate Patient Reported Outcome (PRO) Measure for your Clinical Trial

Programme

Wednesday 5th June 2013

Bloxham Mill Business Centre, Banbury Oxfordshire  OX15  4FF

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 to support regulatory approval or promotional claims.

9.00 – 9.15

Tea/coffee and pastries  

9.15 – 9.30

Welcome and introductions

Plenary

9.30 – 10.00

Quality of life versus health status – Does the EQ-5D and SF-36 measure health status or health-related quality of life?

Presentation

10.00 – 10.45

Selecting the appropriate PRO (1): Assessing classic psychometric PRO properties in the selection process.

Presentation & group session

10.45 – 11.00

Tea/coffee

 

11.00 – 12.15

Selecting the appropriate PRO (2): Understanding the relationship between the PRO, secondary endpoint(s) and the claim in demonstrating treatment effects

Presentation & practical session

12.15 – 1.15

Lunch – Hot and cold food is available in the Bloxham Mill restaurant

 

1.15 – 1.45

Making the choice – the differences between paper and electronic PRO measures.

Presentation

1.45 – 2.15

5 proven devices to collect ePRO, eClinRO, ObsRO including free app for selection

Presentation & discussion

2.15 – 3.00

FDA versus EMA – Similarities and differences in guidelines

Presentation

3.00 – 3.15

Tea/coffee

 

3.15 – 4.00

Identifying the benefits of patient reported outcomes as a valuable adjunct to indicators of medical efficacy in clinical trials and observational studies

Presentation & discussion

4.00 – 4.15

Feedback and Close

Plenary

The sessions: 5-proven devices and identifying the benefits will be hosted by Dr Valdo, General Manager, PHT Corporation.

Valdo is a physician, scientist and entrepreneur who has advanced pharmaceutical research for 18 years. Since founding PHT Europe in 2001 he has opened multiple geographies for PHT products. Valdo received the SCRIP Journal Lifetime Achievement award for his work in advancing clinical research, and has been named to the PharmaVOICE 100 list of the most influential people in the life sciences industries. Previously he founded the first European Central Clinical Laboratory, which became the Covance Central Laboratory, and practiced medicine. Valdo has published articles in top industry publications, and speaks frequently at events which foster clinical research advances. He received his French State Doctor’s Degree in Medicine from the University of Clermont-Ferrand I.

For further information on the workshop to book your place, please contact: info@dhpresearch.com

 Workshop venue details

  • Bloxham Mill Business Centre is located 4 miles South of Banbury town centre in a pleasant, out-of-town location.
  • It is 18 miles North of Oxford. A typical journey time from Oxford is less than 30 minutes.
  • Junction 10 of the M40 motorway is 6 miles away providing rapid connection to a network of motorways including M42, M5 and M6.
  • Banbury and Kings Sutton railway stations are within 4 miles with frequent services. Journeys to London take around 1 hour and 15 minutes.
  • There is a choice of airports in the region: Birmingham, Luton or Heathrow.


Categories: Patient reported outcomes, Uncategorized

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1 reply

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  1. Selecting the Appropriate Patient Reported Outcome (PRO) Measure for your Clinical Trial | DHP Research thepatientoutcomesblog

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