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Overview of ePRO
- 3. Protecting Data Integrity With Paper PRO Manual processes to assure accuracy (source document verification, queries, double data entry and resolution of discrepancies) Reduce error by review of diaries and QoLs at site visits Clear instructions for site and for subjects so they can comply with study requirements re: PRO Availability of PRO in all languages, with appropriate level of translation Attend to psychometric properties of the PRO measures Clearly articulated relationship between the claim, study objectives and PRO measures PAPER PRO
- 7. Validation Decisions: FDA PRO Draft Guidance
- 8. PRO Draft Guidance on Translation of PROs The FDA recommends that sponsors provide evidence that the methods and results of the translation process were adequate to ensure that the validity of the responses is not affected . Sponsors should consider whether generally accepted standards for translation and cultural adaptation have been used to support the validity of data from a translated/adapted PRO instrument
- 10. Data Protections With ePRO No manual transfer and verification of data to database Manual processes to assure accuracy (source document verification, queries, double data entry and resolution of discrepancies) Use programming to prevent errors in data entry while ePRO instruments are being completed Reduce error by review of diaries and QoLs at site visits Clear instructions for site and for subjects so they can comply with study requirements re: ePRO Clear instructions for site and for subjects so they can comply with study requirements re: PRO Availability of ePRO in all languages, with appropriate level of translation Availability of PRO in all languages, with appropriate level of translation Attend to psychometric properties of the PRO measures (ISPOR) Attend to psychometric properties of the PRO measures (PRO Draft Guidance) Clearly articulated relationship between the claim, study objectives and ePRO measures Clearly articulated relationship between the claim, study objectives and PRO measures ELECTRONIC PRO PAPER PRO
- 12. Validation Decisions: FDA and ISPOR Guidelines
- 22. Data Entry Instructions for Subjects ADD THIS: BEFORE THIS:
- 23. “ What Comes Next” Instructions
- 24. Design Strategy: Review Entries to Prevent Duplicates
- 25. More Scenarios Start and End times : Q: What if the event started today but is not yet over when the subject completes the Evening Diary? A: Tomorrow the LogPad reminds the subject to enter the end time. Daily Diary with Additional Questions Weekly: Q: What can be done to assure that these are competed? A: incorporate the weekly questions in the daily diary so that the subject does not have to complete 2 diaries that night AND consider having the weekly questions ‘roll over’ to the next night if the diary is skipped. Subject Safety: Q: How to assure that a subject is safe? A: Alerts using on-device calculations and targeted reports on the LogPad, in StudyWorks, or via email.
- 28. Diary Compliance In Clinic: 7 Trials Number of Doses: Bunionectomy n=119 Hernia n=123 Knee OA n=50 LBP n=52 Vascular n=151 SAR n=1283 Knee OA (2) n=500
- 29. Diary Compliance in Unsupervised Settings Number of Doses: Cancer BTP n=400 Migraine 1 n= 388 Migraine 2 n=25
- 31. Compliance With Integrated Peak Flow Meters 1.01 % Skipped PEF 12.51 % Manual PEF 86.48 % Automatic PEF 12195 Sum of Measures 123 Skipped PEF entries 1526 Manual PEF entries 10546 Automatic PEF entries Count
- 32. Variability by Site: Identifying Targets for Retraining
- 35. Technical Solutions to Human Error: Utility and Cost Processes to Reduce User Error Utility of Fixes Built Cumulative Effort/Cost of Technical Solutions
- 36. Decisions Untangled Processes to Reduce User Error Utility of Fixes Built Cumulative Effort/Cost of Technical Solutions
- 37. What if…? Moderate risk, high benefit No change No. Medium (20% of the time) Exploratory endpoint lost … .the subject oes not complete the 6 hour assessment? Low risk, moderate benefit 2 days Yes. Data summary on StudyWorks Low (have built weekly diary into PM diary with a signature between the two) Primary endpoint data lost … the subject does not complete the weekly diary? High risk, Moderate benefit 5 days No. Invisible until data reconciliation at end of study High (40% of the time) Subjects continue to enter screening diary, not treatment diary. Dosing information lost … the site forgets to enter the visit date? Risk / benefit of design proposed Time required to incorporate into LogPad Can you find it in time to get the necessary data? Risk of this Happening Threat to Data Integrity What if....
Editor's Notes
- (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.