1. NorthWise Services A Comparison Between Electronic and Paper Patient Diaries By Dr. Philip M. North ABEMEP Symposium Electronic Data Capture Friday 11 TH June 2004 NorthWise Services ABEMEP 2004

2. NorthWise Services 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 a number of electronic patient diaries  Staff recruitment agency NorthWise Services ABEMEP 2004

3. NorthWise Services Background of the Speaker  Consultant statistician  24 years in CRO industry, following academic career  Early interest in ecological statistics  Extensive experience of business development and management.  Growing interest in electronic data capture generally and electronic patient diaries in particular ABEMEP 2004

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 ABEMEP 2004

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  Patients can write extensive comments They are often incomplete, inconsistent, inaccurate, biased ABEMEP 2004

6. NorthWise Services Objectives of Electronic Patient Diary Use  Improve patient compliance to protocol  Improve quality of data collected Key objectives are: ABEMEP 2004

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 ABEMEP 2004

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  Potential for multiple use ABEMEP 2004

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 ABEMEP 2004

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) ABEMEP 2004

11. NorthWise Services Desirable Features of an Electronic Patient Diary (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: ABEMEP 2004

12. NorthWise Services Desirable Features of an Electronic Patient Diary (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 ABEMEP 2004

13. NorthWise Services Desirable Features of an Electronic Patient Diary (3)  Capable of handling questionnaires  Secure data storage  Easy and regular downloading of data  Easy access to data for appropriate users ABEMEP 2004

14. NorthWise Services Desirable Features of an Electronic Patient Diary (4)  Comprehensive audit trail  Validated and accepted by regulatory authorities FDA 21 CFR Part 11 compliant  Multilingual capability Cost-effective ABEMEP 2004

15. NorthWise Services Features of Electronic Diary 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 ABEMEP 2004

16. NorthWise Services Collecting Primary Endpoint Information - Remarks  Evidence to suggest that use of electronic diaries can increase the statistical power of the study.  Possibility that study size could be reduced.  Improved return on investment for sponsor  Regulatory authorities might require sponsors to consider use of electronic diaries. ABEMEP 2004

17. NorthWise Services Conclusions  Can be problems with use of paper diaries  Compared with paper, use of electronic diaries can lead to:  Improved patient compliance  Better quality data  Tighter study management  Cost savings ABEMEP 2004

18. NorthWise Services Key Contact Details Telephone +44 (0) 1795 411571 Email philip.north@northwiseservices.comhilip.north@northwiseservices.com Website www.northwiseservices.com ABEMEP 2004