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Valdo Arnera, MD, Jill V. Platko PhD General Manager PHT Europe +41 22 879 91 19 jvarnera@phtcorp.com

Can electronic collection of PROs increase drug safety during clinical trials?” Real-time data collection and data access in clinical trial safety monitoring. 16 June 2009. Valdo Arnera, MD, Jill V. Platko PhD General Manager PHT Europe +41 22 879 91 19 jvarnera@phtcorp.com.

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Valdo Arnera, MD, Jill V. Platko PhD General Manager PHT Europe +41 22 879 91 19 jvarnera@phtcorp.com

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  1. Can electronic collection of PROs increase drug safety during clinical trials?” Real-time data collection and data access in clinical trial safety monitoring 16 June 2009 Valdo Arnera, MD, Jill V. Platko PhD General Manager PHT Europe +41 22 879 91 19 jvarnera@phtcorp.com See what’s new at the award-winning phtcorp.com

  2. Discussion Topics • Safety Monitoring (Monitoring for potential Adverse Events) • Case example: Insomnia Trial-Suicidal Ideation • Case example: Asthma Trial-Worsening Condition • More than just Clinical Trials: Disease Management

  3. Adverse events and paper Safety Monitoring • General (non-study specific) issues • Indication or drug class specific issues • Exam at study visits • Specific Question(naire)s at study visits • Take home diary

  4. Suicide Ideation

  5. Suicide Ideation

  6. Memory of Moods eDiary 4-Week Recall Paisecki et.al., Psychol Assess. 2007 Mar;19(1):25-43.

  7. Case Study: Insomnia Trial • Study details • International trial to treat insomnia in subjects with Major Depressive Disorder • Site Visits spaced up to 4 weeks apart • Quick Inventory of Depressive Symptomatology (QIDS-SR16) completed weekly at home. • Data available in real-time for review by site coordinators and sponsors

  8. Suicide Ideation

  9. eMail Alert From: studySupport@phtcorp.com [mailto:studySupport@phtcorp.com] Sent: Friday, January 09, 2009 5:17 AM To: undisclosed-recipients Subject: Urgent – study participant Suicidal Ideation Alert DO NOT REPLY TO THIS MESSAGE! Dear Investigator, A Subject answered the QIDS question 12 in a manner that indicates suicidal ideation. Please contact the subject immediately and determine if the subject remains eligible for the trial. Please contact Dr. Smith, M.D. at 973-986-3456 if you have any questions. Dr. Smith will be contacting you within 24-48 hours to discuss the subject. Sincerely, The QIDS Alert System

  10. Data Summary

  11. Asthma Trials

  12. Peak Flow Meter

  13. Recording PEF Values We conclude that: 1) compliance with daily peak expiratory flow assessments is generally poor (…) and 2) a substantial percentage of values (22%) is invented. Conclusions- Peak flow diaries kept by asthmatic children are unreliable. Electronic peak flow meters should be used if peak flow monitoring is required in children with asthma.

  14. eSense Case Study: Global Asthma Trial • Study details • International trial with > 500 subjects in 9 countries using portable electronic PEF meter • Subjects take morning and evening PEF values using an eSense PiKo meter by Ferraris Respiratory • Data is available in real-time for review by site coordinators and sponsors

  15. PEF Values Alerts Diary Alerts The following specifications should generate a patient diary alert: Peak Flow measurement less than 50% of Subject’s personal best Explanation: The LP will update and store the Subject’s personal best Peak Flow (morning or evening) on an on-going basis, then compare every new entry to this stored value. If the new Peak Flow measurement is less than to 50% of this stored value, the LP will alert. Alert: “You have indicated a large drop in Peak Flow. Please contact your Study Coordinator.” Example Day 5: Subject enters 300 (LP stores personal best) Day 50: Subject enters 325 (LP updates personal best) Day 149: Subject enters 155 – LP alerts

  16. Case Study: Disease Management Challenge:Reduce hospitalizations and deaths due to COPD exacerbations; improve patient lung function and quality of life. Methods:Subjects use the LogPad daily to answer questions, which are scored in real time; if the score crosses certain thresholds, patients are instructed to contact the hospital’s pulmonary call center for instruction.

  17. Report for Patient Monitoring

  18. Clinician Reaction “This technology, which could easily be used with other diseases, has a truly great impact on patients’ quality of life and the disease cost and burden on society,” Dr. Wissam Chatila Temple Lung Center

  19. Patient Reaction "With the (LogPad) you have a daily routine, seven days a week, so you can't miss it. You can't go wrong … This here keeps me out of the hospital as much as possible. That's what I love about it." Edward GoldwireCOPD patient

  20. Any Questions Valdo Arnera, MD with the precious help from Jill V. Platko PhD General Manager PHT Europe +41 22 879 91 19 varnera@phtcorp.com

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