Transcript Welcome & Opening Remarks

Make the Most of Every Patient
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
[email protected]
See what’s new at the award-winning phtcorp.com
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
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
Suicide Ideation
Suicide Ideation
Memory of Moods
eDiary
4-Week Recall
Paisecki et.al., Psychol Assess. 2007 Mar;19(1):25-43.
Case Study: Insomnia Trial
•
Study details
–
–
–
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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
Suicide Ideation
eMail Alert
From: [email protected] [mailto:[email protected]]
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
Data Summary
Asthma Trials
Peak Flow Meter
Recording PEF Values
Compliance with and accuracy of daily self-assessment of peak expiratory
flows (PEF) in asthmatic subjects over a three month period.
Verschelden P, Cartier A, L'Archevêque J, Trudeau C, Malo JL.
Eur Respir J. 1996 May;9(5):880-5
We conclude that: 1) compliance with daily peak expiratory flow
assessments is generally poor (…) and 2) a substantial
percentage of values (22%) is invented.
Peak flow diaries in childhood asthma are unreliable.
Kamps AW, Roorda RJ, Brand PL.
Thorax. 2001 Mar;56(3):180-2.
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.
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
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
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.
Report for Patient Monitoring
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
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 Goldwire
COPD patient
Any Questions
Valdo Arnera, MD with the precious help from
Jill V. Platko PhD
General Manager PHT Europe
+41 22 879 91 19
[email protected]