1. NorthWise Services Patient Diaries – Electronic or Paper ? By Dr. Philip M. North ACRP Meeting, Budapest Friday 6 th June 2003 NorthWise Services

2. Background of the Company  CRO specialising in services in data management and statistics  Work with electronic patient diaries is a natural extension of this Specific knowledge of 4 electronic patient diaries NorthWise Services

3. Background of the Speaker  Consultant statistician  23 years in CRO industry, following academic career  Growing interest in electronic data capture generally and electronic patient diaries in particular

4. NorthWise Services Patient Diary Cards - Background Some studies require use of patient diary cards for collection of data Sometimes the patient self report is on the primary endpoint, or an important secondary endpoint  Traditional approach is to use paper patient diary cards  One objective: reduce the amount of paper used  Related objective: make best use of modern technology

5. NorthWise Services Problems with Paper Diary Cards  Patients complete them retrospectively, just before appointment with investigator  Patients also complete them prospectively  They are not filled in accurately They are often incomplete, inconsistent, inaccurate, biased

6. NorthWise Services Objectives of Electronic Patient Diary Use  Improve patient compliance to protocol  Improve quality of data collected Key objectives are:

7. NorthWise Services Compliance, Checks and Patient Experience  Patient compliance can be tracked – particularly important in early stages of study  Audit trail is produced  Automatic data entry checks can be built in  Diary devices can be used to accurately record patient experience Quality of life data can be collected Collect data in real time

8. NorthWise Services Time and Costs  Use of new technology reduces development time, hence time to market for a product – leads to increased revenue for the pharmaceutical company  When all related costs are taken into account devices can be cheaper than paper diaries

9. NorthWise Services Published Comparison - Electronic vs. Paper  Key publication : Patient non-compliance with paper diaries (BMJ, Vol 324, 18 May 2002)  Data quality and compliance from paper diaries might be poor, but how can we tell which are the poor data ?  Money is wasted if spent on collecting poor quality data

10. NorthWise Services Results reported in the BMJ paper NorthWise Services 30 minute window Total number of episodes Number of excluded episodes Mean % compliance (95% CI) Actual Reported 90 minute window Total number of episodes Number of excluded episodes Mean % compliance (95% CI) Actual Reported 24452435 126 7 11(8 to 14)94(92 to 96) 90 (86 to 94) 2445 134 20 (14 to 25) 95 (92 to 98) Paper diaryElectronic diary (n=40) (n=40)

11. NorthWise Services Desirable Features of an Electronic Patient Diary Device (1)  Very portable (light, compact, fitting into pocket or handbag) Note: laptop computers or large devices are not portable enough  Easy to use  Acceptable/attractive to patients across wide age range Reminders for patients The device needs to be or have:

12. NorthWise Services Desirable Features of an Electronic Patient Diary Device (2)  Capable of customisation – study dictates what is on the device rather than other way round  Accommodation of patient’s lifestyle  Durable Water resistant (possibly) Long-lasting power source

13. NorthWise Services Desirable Features of an Electronic Patient Diary Device (3)  Secure data storage  Easy and regular downloading of data  Easy access to data for appropriate users

14. NorthWise Services Desirable Features of an Electronic Patient Diary Device (4)  Comprehensive audit trail  Validated and accepted by regulatory authorities FDA 21 CFR Part 11 compliant  Multilingual capability Cost-effective

15. NorthWise Services Features of Diary Device Use  Patient interacts with the data collection device and not the investigator and other site personnel  The user interface and device design are keys to successful patient compliance  Data capture and processing are highly efficient, compared to paper diary processing Dedicated industry suppliers provide technology solutions and support

16. NorthWise Services Key Contact Details Telephone +44 (0) 1795 411571 Email philip.north@northwiseservices.comhilip.north@northwiseservices.com Website www.northwiseservices.com