Agenda. ARITHMOS Presents: Introduction to epro. EDC and epro integration General Overview. epro and ecrf Integration: a case study

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1 Agenda ARITHMOS Presents: epro and ecrf Integration: a case study Introduction to epro EDC and epro integration General Overview From epro to ipro: Technology trend in Pharma epro EDC integration: A case study Milano 16 January 2012 Stefano Piccoli, Chief Operating Officer Conclusions

2 Introduction to epro Introduction to epro Paper Reported outcomes diaries have been used for thirthy-plus years of clinical research The benefits of epro compared to paper-based PRO: Several Compliance and accuracy issues of at-home paper diaries collected and observed in Clinical Trials A study has been conducted to assess the benefit to use epro vs PRO diaries Mean % Compliance Paper diary (n=40) Electronic diary (n=40) Actual Reported 90 Stone, Shiffman, Schwartz, Broederick, Hulfors - British Medical Journal 324: (2002) Less administrative and cost-effective Increase of patient compliance from 30% with paper to 90% with an electronic method such as devices Real-time data so trial leaders can make more educated and adaptive decisions and intervene immediately if a problem occurs Market shifting towards user-friendly devices like smartphones and tablets (ipad) Quicker Data Cleaning process, reducing Data Management costs Full integration is possible with EDC systems Multi-language and global study data are in a single database Devices appsallow access to study resources in a worldwide database

3 Introduction to epro and EDC The growth of Electronic Data Capture drives the adoption of epro. EDC is the actual collection of patient data. Clinical site staff have recognized the benefits of using EDC solutions. Faster trials mean lower drug development costs Immediate feedback means more effective trials Integration: epro and EDC Increased widespread adoption of eclinical tools: EDC, studies Sponsor, CROs, Clinical sites must interact with multiple applications throughout the life of a trial Sponsors need to integrate different data (captured with different technologies) in one system. Availability of combined data allows efficient and effective decision making & enhance the overall drug dev process

4 Integration: epro and EDC epro and EDC Integration Good Practice Designs A vivid example of integration is epro & EDC integration Integration of Patient Recorded Outcomes and Case Report Forms into Electronic Data Capture Systems: Reduce the risk of trial delays by eliminating discrepancies Synchronization of data to offset conflicts in two isolated datasets Reducing trial delays saves time and inevitably expenses Clinical Trial leaders (Monitors & Investigators) are concerned about the time required for integration will cause trial delays. Integration should support data transfers in real time to eliminate the chance of outdated datasets and discrepencies Integrated systems required a central database to store data for all trial subjects. security measures to ensure confidentiality of data (encryption, trasmission, access management) Real Time

5 Integration: What is Needed Benefits of Integration: epro and EDC Role Site personell Benefit Enjoy convenience of logging into 1 system Investigator can proactively drive subject behaviour to ensure compliance with the study. The epro device with questionnaire Connection HTTPS on Internet Web server Remote Data Capture - EDC System Data Manager Sponsor Run real time edit checks against subject diary in the EDC system Having ad-hoc reporting of epro/edc data together in real time Electronic time stamps in patient diaries are viewable in EDC Resolve discrepancies in a faster way, faster DB lock Ongoing control on study progress

6 Data Management Statistics Topic ecrf and epro not integrated ecrf and epro integration Topic ecrf and epro not integrated ecrf and epro integration Query management epro data availability Accelerated End of study or transfer to separate database. Risk of data loss Accelerated Real time transfer in ecrf during the study epro data review Device display Real time in ecrf Study Metrics epro data and relevant patient binding. Based on ecrf data only. None on epro data Manual activity, at study end only Available and up-to-date on ecrf, epro and derived data. Automated and real time binding CRF and epro data inconsistencies check At last stage with different data sources. Adaptive trials difficulties Real time checks. Adaptive trials with decision points during the study Timelines for study data availability Statistical Report Months, due to epro data collection Carried out in the long term. High risk of data binding errors. Blind Review Meeting and DB lock few days after LPLV Carried out in the short term. Very low risk of data binding errors

7 epro Devices: Market Trends epro devices like a PC have been typically stored on-site and all patients use this device. The market is shifting towards individual, handheld devices which patients can use at home. Using an Internet connection allows docter-patient communication Investment by the pharma industry in wireless devices has grown 78% in the past year 88% of patients and 91% of clinical staff prefer epro: patient compliance increases significantly with intuitive devices. SMARTPHONES & TABLETS - Individually distributed with no assembly required - Questionnaire appears in the same format for each patient - Data submitted automatically, no burden on the patient - epro Devices: Smartphones iphone BLACKBERRY CURVE OR TORCH Patient Identification: 7 digit BB PIN number which can confirm patient compliance Secure data transfer, deactivation is possible and communication is encrypted Data can be transferred using SMS, BBM or Bluetooth Patient identification with username and password Secure data transfer, encrypted communication Data transfer with SMS, imessanger, Bluetooth icloud also available for storage in multiple locations

8 epro Devices: Tablets and the ipro Trend epro Devices: Physicians and the ipad ipad and the TABLET TAKEOVER Fast-growing market, Apple owns 90% market share with ipad Ideal device for patient compliance Look and feel of using paper and large screen which is convenient for the patient Factor; easy-to-use and intiuitive apps over health-related apps available 3G/4G capabilities for real time interaction between patient and clinical leaders. 27% of physicians have tablet computers such as ipads 79% of Physician say they prefer ipad for clinical use New technology allows for diagnosis and tracking medical progress; apps can now monitor heartbeats and manage glucose levels. The ipad brings doctor-patient relationship closer ARITHMOS has recently integrated BI reporting with the ipad for accessing study &safety data anytime, anywhere.

9 CASE STUDY Business requirements: Observational Study Primary Endpoint: Validation of epro Questionnaire Solution: Questionnarie as ipad app Integratation between epro & EDC system CASE STUDY Study Requirements Observational study Study duration: 1 year Primary Endpoint: validation of questionnaires 2 electronic Questionnaires Over 300 patients 20 sites

10 CASE STUDY CASE STUDY Technical requirements: ipad2 1 ipad2 for each site OpenClinica has open source ecrf Integration between ipad questionnaires data and clinical DB Constraints and strategy for epro Questionnaire available in the Apple Store Patient Data on ipad encrypted Personal credentials to access the questionnaire Data file format agreed with software producer (XML)

11 CASE STUDY Constraints and strategy for ecrf integration (1/2) Web portal to receive, decrypt and forward the data to the Clinical database CASE STUDY Constraints and strategy for ecrf integration (2/2) Study database set up and validated in the ecrf application according to the study protocol Real time jobs to upload the Questionnaire data in the ecrf Real time metrics available to sponsor for questionnaire data comparison during the study Prompt alerting system for unsuccesfull uploads and Procedure in place to upload failed jobs Questionnaires pages on ecrf available for Sponsors and DM only; not to investigators

12 CASE STUDY - Questionnaires on ipad CASE STUDY epro/edc Integration Solution Overview With the ipad you have the following advantages: Big Screen for the patients Big buttons for VDS Multiple languages support Many questions available on the same screen Long text questions available Touchscreen Automatic score computation USB connection https on internet Arithmos Data Center Web portal Real Time Integration Modular Architecture OpenClinica

13 CASE STUDY Validation strategy ecrf Integration in EDC system https on internet Web server OpenClinica Validation of different steps End to End process validation performed through integration testing Questionnaire available in the ecrf page The questionnaire data can be reviewed by Data Managers and Sponsor Personnel only

14 TRAINING & SUPPORT First Feedback Training on ecrf for investigators 3 tiers help desk for investigators and study personnel ipads maintenance and management Minimum training required on ecrf/ipad (average 15min/investigator) ecrf application easy to use by the investigators ipad very well accepted by patients. No helpdesk ticket received for support. Ease for Investigator to support patients on ipad questionnaires entry Metrics easy to set up and easy to be downloaded Data upload process in a few seconds

15 Conclusions Thanks Continuos innovation will lead to significant uptake of epro EDC integration Mobile Health App are predicted to grow significantly in the next years Dynamic ecrf? Smartphone as medical device How would the Regulatory Authorities handle an increased regulatory workload?