Overview of ePRO
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Overview of ePRO

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Overview of ePRO

Overview of ePRO

Barbara Marino, PhD, RN
Director Clinical Operations, Scientific Advisor
PHT Corporation

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  • (Personalized intro’s and thank you for your time)
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.
  • Assumptions: We identify as many user errors as we can which could effect data quality: the “What if….?” questions during requirements gathering We use productized programming to prevent errors. We develop programming to prevent errors not addressed by our productized solutions We base our reasoning for the error-prevention programming on best practices, previous experience and our best judgment We have very little data to support any of the fixes: how often they are used in the field, amount of effort v. amount of value to sponsor: the utility of the fix is unknown. The fixes can be expensive in time and money, especially those that are unique, not already productized. Example: study with timed assessments prior to and after dose of study medication. Subject gave the dose of medication in the clinic. To allow sites to support subject, if subject did not enter time of dose, site could enter it and the device would begin timed assessments based on time of dose. Seemed like a good idea: didn’t want subject to get blocked. Slow to spec and build and test. Actually used 7 times in 1500 doses. What to do? Don’t assume all fixes have equal utility Collaborate with sponsor on the value of the proposed solution Test the design in simpler mode during Phase 2A (unless sponsor plans for Phase 2 o be confirmatory) Consider training as the low tech solution Use reminder messages in the diaries to help subject/site personnel adhere to protocol Collect data: evidence based designs
  • With evidence based designs, we can see where there are fixes that don’t contribute much to data quality but keep adding to the price
  • Based on PHT’s experience with over 90 biopharmaceutical clients, we find study sponsors such as yourselves first want to know how ePRO can improve their global clinical research programs, and second why they should choose to work with PHT. With my presentation and live product demonstration today, I hope to leave you with a more thorough understanding of how the LogPad System and SitePad Tablet work, and why PHT has grown to become the clear market leader. I would also like to learn about your specific eClinical requirements, including any frustrations with current processes or concerns about ePRO you may have.

Overview of ePRO Overview of ePRO Presentation Transcript

  • Make the Most of Every Patient An Overview of ePRO Prepared exclusively for Breakfast Seminar Participants 19 March 2009 Barbara Marino, PhD, RN Director Clinical Operations, Scientific Advisor 617-973-1612 blmarino@phtcorp.com See what’s new at the award-winning phtcorp.com
  • Agenda • ePRO Across Technologies • Why Use ePRO • How ePRO Works • Where ePRO is Used • What We’re Learning About ePRO • ePRO Next Generation PHT Confidential www.phtcorp.com
  • Patient Reported Outcomes (PRO) on Paper CHECK THE ONE RESPONSE TO EACH ITEM THAT BEST DESCRIBES YOU FOR THE PAST SEVEN DAYS. PHT Confidential www.phtcorp.com
  • ePRO: Interactive Web Response (IWR) PHT Confidential www.phtcorp.com
  • ePRO: Interactive Voice Response (IVR) When you hear the answer that best describes you for t he past 7 days, say "Yes" or enter 1 on your telephone keypad. If the answer does not describe you, say "No" or enter 2 on your keypad. Yes During the past 7 days, most of the time I awaken no more than 30 mintues before I need to get up. No More than half of the time I awaken more than 30 Yes miuntes before I need to get up. No Yes I almost always awaken at least 1 hour or so before I need to but I go back to sleep eventually. No Yes I awaken at least 1 hour before I need to, and can't go back to sleep. No Advance to Question 4 . PHT Confidential www.phtcorp.com
  • ePRO: Tablet or Handheld Computers PHT Confidential www.phtcorp.com
  • Why Use ePRO? Data Quality on Paper Four types of paper responses: Perfect Patient Impossible to verify response date/time The Forgetful Patient Provides no data at all; takes weeks to notice Selective Patient Missing data presents data analysis issues Enthusiastic Patient Great energy, unusable data; ideal on a LogPad Courtesy of Dr. Stuart Donovan, Knoll Pharmaceuticals PHT Confidential www.phtcorp.com
  • Why Use ePRO: Data Accuracy on Paper Observed vs. Purported Measurements & Errors Observed (Objective) Purported Discrepancies Number of Compliance (Written in Diary) Between the Two Subjects Compliance A. Stone et al, BMJ 2002; 324:1193-4 11% 90% 79% 80 G. Jonasson et al, Eur Respir J,14,1999 77% 93% 16% 163 H. Milgrom et al, J. of Allergy & Immunol.,98, 1996 58% 95% 37% 24 S. Spector et al, J. Allergy Clin. Immunol.,7,1986 47% 90% 43% 19 R.J. Straka et al, Pharmacotherapy,17,1997 55% 71% 16% 68 P. Verschelden et al, Eur Respir J,9,1996 22% 20 F.Chmelik et al, Annals of Allergy,73,1994 58% 20 M. Simmons et al, Chest, 118, 2, 2000 30% 101 R. Mazze et al, The Amer. J. of Medicine,77,1984 74% 19 Averages 59 + 13% 87 + 11% 42 + 21% 57 PHT Confidential www.phtcorp.com
  • How ePRO Works: an ePRO System ePRO Designer StudyWorks LogPad Redundant Central Servers Sites/Sponsors Subjects Hosted at two secure third- party co-location facilities SitePad Study Archive Sites Sites/Sponsors PHT Confidential www.phtcorp.com
  • How ePRO Works: Take a Look Demonstration of ePRO on a Handheld PHT Confidential www.phtcorp.com
  • Where ePRO is Used eDiares Used Here No Recent eDiary Trials PHT Confidential www.phtcorp.com
  • Languages and Dialects Supported Afrikaans (South Africa) French (Canada) Arabic French (France) Russian Arabic (Tunisia) German (Austria) Russian (Israel) Armenian German (Germany) Serbian Bulgarian Greek Slovak Cebuano-Cebu Hebrew Spanish (Argentina) Chinese Simplified (China) Hiligaynon Spanish (Chile) Chinese Simplified (Singapore) Hindi Spanish (Colombia) Chinese Simplified (Taiwan) Hungarian Spanish (Latin America) Chinese Traditional (Hong Kong) Icelandic Spanish (Mexico) Chinese Traditional (Taiwan) Indonesian Spanish (Peru) Croatian Italian Spanish (South America) Czech Japanese Spanish (Spain) Danish Kannada Spanish (Universal) Dutch (Belgium) Korean Spanish (US) Dutch (Netherlands) Latvian Spanish (Venezuela) English (Australia) Lithuanian Swedish English (Canada) Malay Tagalog English (Hong Kong) Malayalam Tamil English (India) Marathi Telugu English (New Zealand) Mongolian Thai English (South Africa) Norwegian Ukrainian English (UK) Polish Urdu English (US) Portuguese Vietnamese Estonian Portuguese (Brazil) Xhosa Finnish Romanian Zulu French (Belgium) PHT Confidential www.phtcorp.com
  • Where ePRO is Used: Therapeutic Areas Allergy Allergic rhinitis, conjunctivitis/rhinitis, cat allergy, ragweed, grass/pollen, seasonal rhinitis Behavior Modification Smoking cessation Cardiovascular Anti-arrhythmia, deep vein thrombosis, dyslipidemia Endocrinology Diabetes, pregnancy prevention, vasomotor symptoms Gastrointestinal Crohn’s disease, chronic constipation, irritable bowel syndrome, Gastroesophageal Reflux Disease , heartburn, pediatric gastrointestinal disturbances Genitourinary PMS, dysmenorrhea, female sexual dysfunction, Erectile dysfunction, urinary incontinence Immunology Common cold, HIV, herpes , vaccines Neurology ADHD, ADHD with tic disorder, bipolar disorder, insomnia, mild cognitive impairment, multiple sclerosis, Parkinson’s disease, restless leg syndrome, sleep disorders, Weakness/Paralysis Oncology Breast cancer, multiple myeloma, prostate cancer. oncology pain CNS (including Pain) Analgesia, chronic pain, dental pain, diabetic neuropathy, low back pain,, post-surgical pain, neuropathic pain, radiculopathy, post-herpetic neuralgia, bunionectomy, fibromyalgia, migraines, rheumatoid arthritis Respiratory Asthma, COPD Other Infectious diseases, osteoarthritis Trials by Phase… Pilot/Phase I: 6% Phase II: 34% Phase III: 42% Phase IV: 18% PHT Confidential www.phtcorp.com
  • ePRO and Objective Patient Data eSense Measurement Devices – Appropriate and timely use of devices (e.g. PEF meters, glucometers) – Bluetooth, infrared or exclusive radio integration – Timestamps, windows for completion to assure accuracy Cognitive Assessments – Response time and concentration as efficacy measures – Seamless integration with eDiary – Endpoint in areas like insomnia, migraine, Alzheimer's Adverse Event Monitoring – Identify responses from subject diary that indicate possible AE – Alert subject and site – Escalating alerts for serious conditions PHT Confidential www.phtcorp.com
  • ePRO Integration With Other Trial Information ePRO and EDC Integration Experience – Populate EDC forms with diary data – Simplify management for sites – Use CROs to merge data from multiple streams for a paper-free trial – CDISC ODM export certification More Than EDC – eSense devices – Adaptive trial designs – Eligibility data from multiple providers – Cognitive assessments Seamless EDC Integration PHT has invested in CDISC ODM certification to ensure its XML eSource data are easily integrated with other compliant eClinical systems PHT Confidential www.phtcorp.com
  • What We’re Learning: ePRO and Data Quality – Insomnia: standard care – 35% lower standard deviation – Study power with 56% fewer subjects – Potential $340,000 in savings – Constipation in men – Phase III trial called for 1,026 subjects – Approval granted after 322 enrolled – Efficacy was proven with 69% fewer patients – Female Sexual Dysfunction – Comparison of ePRO and PRO – No treatment – 50% more encounters reported with ePRO PHT Confidential www.phtcorp.com
  • Data Variance ePRO and Paper in Merck Pilot Data from Paper Diary Arm – Clustered distribution around 6 intervals (30, 60, 90 minutes) suggests recall bias or invented data 5 – Wide range of responses (from 20 minutes less to 6 hours more sleep) Number of Patients 4 Data from eDiary Arm – Statistically equivalent 3 mean, with significantly smaller data variance – More Gaussian distribution, 2 tighter around the mean 1 Change in Sleep Time 0 -20 20 60 100 140 180 220 260 300 340 380 420 (minutes) PHT Confidential www.phtcorp.com
  • Merck Pilot: Summary of Results Area of Interest in Trial PHT LogPad Paper Diaries Calculated patients to yield 90% study N=44 N=101 (56% more than power LogPad) Potential cost savings $340,000 * -- Distribution of responses More Gaussian Suggests recall bias Standard deviation 35% smaller -- Sleep Change estimates Nearly identical -- Coefficient of variance Significantly smaller -- Data Point Changes and Notification Forms -- 3x more of each Compliance (% of diaries completed) 92% objective 96% purported subject subject compliance compliance Cost: Data Entry (hr) 0 58 Data Review (hr) 10.5 10.5 * Estimated by assuming a total per-patient cost of $6,000 Results presented at DIA 2004 and at the International Society for Quality of Life Research (ISOQOL) 2004 symposium PHT Confidential www.phtcorp.com
  • The Elderly and ePRO Average Compliance by Age Group Diabetic Neuropathy – Subjects Aged 32-93 86% 85% 90% 91% 100 Average Compliance 90 80 70 60 50 40 30 20 10 0 Younger 50-59 60-69 70 or than 50 (n=41) (n=41) Older (n=22) Age Group (n=19) PHT Confidential www.phtcorp.com
  • eSense Case Study: Global Asthma Trial Study details – Global Phase IIb trial with > 500 subjects in 15 countries using portable electronic PEF meter – Sponsored by a Top-5 pharmaceutical company – Subjects take morning and evening PEF values using an eSense PiKo meter by Ferraris Respiratory – Subjects complete an evening diary on an eSense LogPad – Data is available in real-time for review by site coordinators and sponsors New Gold Standard Operational data from a global asthma study indicate subjects use eSense even when allowed to transcribe data manually. eSense: 86% Manual: 13% Skipped: 1% PHT Confidential www.phtcorp.com
  • Summary: ePRO Advantages • Trustworthy patient data – Verified time of entry – Complete, legible, logical reports – Front-end edit checks – Improved reliability and validity • Reduced respondent and site burden • Real-time trial and subject management • More reliable data for regulatory submissions • Smaller sample sizes in Phase II • More conclusive trials in Phase III • Adaptive trial designs • Efficient data collection process • Ability to ask new scientific questions – eSense measurement devices – Cognitive assessments PHT Confidential www.phtcorp.com
  • Thank You! Questions? Barbara Marino PHT Corporation 617-973-1612 blmarino@phtcorp.com Visit the new www.phtcorp.com PHT Confidential www.phtcorp.com