5 Ways to Collect ePRO

Collecting Electronic Patient-Reported Outcomes (ePROs): Comparing the 5 Proven Ways to Acquire Attributed Patient-Reported DataThe specialized industry of I. The Growing ePRO Industrycollecting electronic patient- In 2010 it is estimated that 30% of new global trials will require subjective patient data, ie theyreported outcomes is increasing will collect patient-reported outcomes as an endpoint. While paper diary collection is the defaultlinearly, in part because global method for many latent-adopters of new technologies, electronic capture of patient-reported outcomes is growing steadily as sponsors realize the revenue advantages of more accurate,government regulators want to hear attributable patient-reported data.directly from the patient, and becausethe acceleration and availabilityof electronic collection (vs. paper ePRO Market, 2009–2015collection) improves data quality andefficiencies for data analysis and 300trial management. This documentwill review the ePRO market, and 250outline the five ePRO methods that Market Size ($m)successfully support the collection 200of patient-reported data. 150 100 50 0 08 09 10 11 12 13 14 15 20 20 20 20 20 20 20 20 Contents The ePRO market was valued at $150m in 2008 and is expected to reach $265m in the year 2015. The market will grow at a CAGR of 8.5% between 2008 and 2015. Increasing I. The Growing ePRO Industry p.1 penetration of these solutions is the main factor responsible for the growth1. II. The Process of Collecting p.2 Electronic Patient-Reported Outcomes PHT Corporation was one of the first organizations to specialize in collecting and reporting III. The Five Reliable Collection p.3 patient-reported outcomes electronically. Since 1994 the PHT ePRO System has become the Methods and Devices Used to market’s ePRO system of choice, used in 400+ clinical trials. Unlike other ePRO providers, Collect ePRO PHT is dedicated to ePRO as its core competency. Conclusion p.5 PRO Decision Tools p.6

2Collecting Electronic Patient-Reported Outcomes (ePROs)II. The Process of Collecting Electronic Patient-Reported OutcomesRecommendations for collecting PRO measures have been set forth by Clinical trials using PRO measures should be designed so that:the Guidance for Industry, Patient-Reported Outcome Measures: Use in • Endpoint models are clearly associated with the intended claimsMedical Product Development to Support Labeling Claims2, the Reflection • PRO measures are valid, reliable and sensitive to changePaper on the Regulatory Guidance for the Use of Health Related Quality • The conceptual framework of PRO instruments is well definedof Life Measures in the Evaluation of Medicinal Products3, and guidelinesfrom other regulatory agencies4. • Evidence is compelling that PRO data collection was completed at times specified in the protocol As a result of these guidances, the process of collecting electronic patient-reported outcomes requires much more than a collection device, database, and a diary or questionnaire! Since 1994, the PHT ePRO System has included all the distinct yet interoperating functions as shown below. PHT’s quality management system is certified to ISO 9001:2008. Functional Overview of the PHT ePRO System 1 2 3 4 Consulting/PROVision Preparation/Testing Go Live/Data Collection Data Distribution/Archive 1.1 Provide developing (or final) 2.1 Secure permissions to use 3.1 Oversee PHT’s Data 4.1 Final protocol. copyrighted eDiaries and/or Collection System and Project transmission questionnaires. Translate and Localize Reporting (GO LIVE!) of selected PRO 1.2 Science Team Protocol each eDiary and Questionnaire to data to sponsor Consultation (complimentary) on ensure global All key server for analysis. required endpoint data points, FDA consistency. functions are Preparation of & EMA expectations, eDiary designs redundant archival records and ePRO symptom scales. Define 2.2 Selection of all eSource and study documentation d project requirements including risk of Devices for sites to retain and for regulatory analysis and mitigation plan. and Design of inspectors to use in reconstructing Applications, using a design tool sing the trial. PROVision™ Science Team that formats PRO measures for eDiary use. Steve Raymond, Ph.D. 2.3 Design, Test and Verify the ePRO Founder, Chief Scientific Database and ePRO System to support and Quality Officer the scientific objectives of the protocol. 2.4 PHT provides ePRO documentation Valdo Arnera, MD for sponsors to submit with their General Manager of PHT’s European protocol to EC’s and IRB’s. 3.2 Secure, controlled and Operations documented, role-specific access 2.5 Prepare ePRO system for User for study staff to PRO data online Acceptance. for trial management and patient Barbara Marino, Ph.D., RN monitoring. 2.6 PHT supports sponsor training of Senior Scientist, Director of Outcomes sites by providing expert presenters and Study Design who know the details of each trial and are equipped with hands-on devices and trial-specific training materials. Jill Platko, Ph.D. Scientific Advisor 2.7 Train PHT’s ePRO Study Support Group. Key: While PHT works collaboratively with study teams, some steps are taken primarily by the sponsor/CRO and are highlighted in orange type.

3Collecting Electronic Patient-Reported Outcomes (ePROs)III. The Five Reliable Collection Methods and Devices Used to Collect ePRO ...using the patient’s own The second function within the PHT ePRO System – Selection of Devices • Alterations to a PRO measure validated and Design of PRO Applications – is the subject of this issue. While the for one device when it is displayed and technologies to capture flurry of new patient-owned mobile devices may seem adaptive to ePRO used on other devices, andePRO can be risky for many collection and perhaps practical, using the patient’s own technologies • Data security and compliance with reasons... to capture ePRO can be risky for many reasons including: regulatory guidelines.Each ePRO collection method and device must be thoroughly vetted in order to comply with various FDA, EMA and country regulations and requirements fortrustworthy data. As a result, there are currently five proven and tested ePRO technologies used by sponsors today (listed alphabetically): 1. Hand 2. IVR 3. Internet Webb 4. Pen: Digital 5. Tablet: Held Device: (Interactive data capture pen that Electronic data Electronic data Voice Response):: with a central captures data capture on a capture on a Keypad or voice system that and uploads to tablet mobile Hand Held IVR Internet Pen Tablet mobile device data capture allows for web a central system m device with awith a central system that allows with a central system that allows review by site and sponsor; that allows for web review; and central system that allows for l hfor web review; for web review by site and sponsor; web review.Following is a review of each collection option, recognizing that the ideal method of acquiring patient reported data is contingent on eachtherapeutic indication, size, complexity, length, locations, survey elements, patient population, budget and critical success factors. Further, eachmay be used by itself, or in a combination with others, depending on how the study protocol prioritizes the preceding criteria. It is assumed thateach collection method is an integral part of a validated ePRO System that protects and ensures data integrity, source and attribution.1. Hand Held Device: Electronic data capture on a mobile device with a central system that allows for web review. Hand Held Devices are pocket-sized computers, PHT has extended this modality’s capacity to include preferred for collecting data from patients at work, • Integration with PEF meters and glucometers, which collect objective at home, or in transit. They are especially useful for readings on the Device; protocols that require data from frequent or episodic incidents. Patients can be prompted to fill in • On-device calculations and comparisons with previous readings and Hand Held medical device measurements, without transmission or uploading responses according to the protocol time guidelinesvia alarms and reminders, and only allowed to enter diaries within specific requirements;time windows. This provides cleaner data than paper diary collection, • Psychometric validation of PHT Hand Held data capture elements such asand makes integration with a reminder system not necessary. Hand Held the eVAS, to ensure that sponsors using PHT systems are collecting validDevices are well accepted throughout the world, having been used to send data; anddata directly from patients at home to a centralized server since 1995. • Optional safety reminders triggered by on-device calculations to patients forThese smart devices collect data in complete, logical and legible formats; medicine, diary and/or activity prompts; to site personnel for extreme highand use a touchscreen that can be adapted for easy use by patients low patient dosages, irregular/infrequent diary entries and/or compliancechallenged by hand/eye coordination, arthritis or motor disorders. Hand management; and to sponsors and CROs for site data out-of-range.Hand Held Devices are ideal for collecting data using long and/or complex The Hand Held Device is the most widely-used method for collectingdiaries, as tends to be the case for protocols for Alzheimer’s, arthritis, electronic patient-reported outcomes at clinical sites, and from patientshep c, oncology and psychiatric indications. The screen size should be at their work, home or in transit. It can be integrated with medical deviceslarge enough to present an entire item (stem and response options) and other technologies to combine objective measurements; and with IVRwithout scrolling that might bias against selecting hidden options. The to streamline subject enrollment and randomization. Electronic capturescreen size also dictates whether Visual Analog Scale (VAS) scales and on a Hand Held Device automatically provides patients with the logicallyimages can be appropriately viewed. appropriate questions/items at the correct times, simplifying diaryHand Held Devices can streamline mid-study changes by deploying completion and ensuring that sponsors receive reports with entirely logicalchanges seamlessly from a centralized server, at a scheduled time. response structures. When functioning within a closed-loop ePRO System,For more than 15 years, PHT has utilized Hand Held Devices for ePRO Hand Held Device data is accessible real-time, enabling sponsors and sitecollection. As a result of employing this method for so many protocols, personnel to manage compliance and monitor subject safety between visits.

4Collecting Electronic Patient-Reported Outcomes (ePROs)III. The Five Reliable Collection Methods and Devices Used to Collect ePRO – Continued.2. IVR (Interactive Voice Response): Keypad or voice data capture with a central system that allows forweb review by site and sponsor. The second most frequently method used IVR compliance is strained when subjects lose track of, or tire waiting to collect ePRO is IVR, due to its wide to hear, the entire list of response options, which can bias them to availability and common use in a wide variety select the first options to occur. IVR also limits the ability for clinical of applications available on the market. IVR researchers to ask all the requisite questions. Unlike the Hand Held IVR is familiar to use, and is favored over paper Device, IVR systems do not have the capacity to display graphical diaries for branching logic and data integrity. elements and cannot utilize visual scales.IVR is primarily used for short and simple diary data collection, and IVR is limited in capacity to collect ePRO, impeded by the public’sintegration with other ePRO modalities to streamline enrollment low tolerance level for calls longer than 5 minutes. It is not typicallyand randomization. interactive based on real-time subject responses, and unable toLike Hand Held Devices, IVR can streamline mid-study changes trigger safety reminders for subject safety and compliance rates. Asby deploying changes seamlessly from a centralized server, at a a result, IVR technologies are employed for short and simple diariesscheduled time. or (more commonly) integrated with Hand Held Devices to streamlineIVR presents usability challenges for countries without advanced subject enrollment and randomization.phone systems, and for surveys with lengthy or complex questions.3. Internet Web data capture with a central system that allows for web review by site and sponsor The Internet is gaining popularity as an ePRO reliable Internet connection. If used outside the clinical setting, collection modality, as global population gains the patient must be near the computer for episodic or frequent access to the Internet on a reliable basis. diary collection. Like the Hand Held Device, the Internet can The Internet has been used successfully for ePRO data collection using Internet execute complex and lengthy diaries and desktop computers; Internet Web data capture via Hand Held is being questionnaires with images and visual scales, explored at this writing. For acceptance by regulatory authorities, thisand streamline mid-study changes by deploying changes seamlessly new instrument must be validated and proven to display consistentfrom a centralized server, at a scheduled time. diaries and questionnaires on screen, regardless of the Hand HeldThe Internet can be employed at the clinician site or at the patient’s device or Web browser.home, office or school; but must be located in a private setting with a4. Pen: Digital pen that captures data and uploads to a central system that allows for web review. The Pen relies on the patient using a unique Contrary to the Hand Held Device, IVR or Internet Web data capture, writing instrument on special paper printed the Pen requires extensive cleanup of data towards the end of the with the diary or questionnaire. Some Pen trial, and yields significantly less valuable data per patient. The Pen systems cannot prevent patients from skipping does not provide real time feedback in the language of patients. It answers, entering illogical data and entering must be combined with a reliable reminder system, to ensure date Pen data outside of protocol specified time entry dictated by the protocol.windows. Since sites and patients must use assigned papers anda Pen, the cost for Pen ePRO collection includes all the duplication,transportation and redundant data entry costs of paper diaries plusthe added expenses of unique pens.

5Collecting Electronic Patient-Reported Outcomes (ePROs)5. Tablet: Electronic data capture on a tablet mobile device with a central system that allows for web review. Tablets are popular for site-based data, For more than 5 years, PHT has utilized Tablets for ePRO collection. where they are often used to collect patient- As a result of employing this method for many protocols, PHT has reported, clinician-reported outcomes and/or extended this modality’s capacity to include questionnaires. Tablets are used by patients • On-device calculations and comparisons with previous readings Tablet and clinicians at the site, and are often and medical device measurements, without transmission or integrated with Hand Held Devices which uploading requirements;are used by the patien at work, at home, and in transit. They can patientupdate drug inventories and other calculations to streamline clinical • Psychometric validation of PHT Tablet data capture elementsadministration, which can be burdensome as with some oncology such as the eVAS, to ensure that sponsors using PHT systems aretrials where treatment is especially costly. Tablets are impractical for collecting valid data; andmobile patient data collection. • Optional safety reminders triggered by on-device calculations toLike the Hand Held Devices, Tablets collect data in complete, logical patients for medicine, questionnaire and/or activity prompts; toand legible formats. Some are touchscreen; others use a stylus which site personnel for extreme high/low patient dosages, irregular/is attractive for patients with challenging hand/eye coordination, infrequent diary entries and/or compliance management; and toarthritis, or tremors. Tables are ideal for collecting data using long sponsors and CROs for site data out-of-range.and/or complex questionnaires, as within protocols with Alzheimer’s, Tablet ePRO collection at clinical sites will continue to increase withArthritis, Hep C, Oncology and Psychiatric indications. The larger the proliferation of new Tablet technologies and Internet access.Tablet screen is ideal to view VAS scales and images. Tablets canstreamline mid-study changes by deploying changes seamlessly froma centralized server, at a scheduled time. Conclusion:Each of the five distinct ePRO collection methods has been the ePRO industry with its ePRO System, actively buildingused for successful data submission to regulatory agencies; its scientific and technological infrastructure to meetand each has specific utility for protocol requirements. increasingly rigorous demands of the market.As technologies broaden and data collection devicesbecome more of a commodity, it will become more apparentthat the ePRO ‘System’ bears the burden of deliveringhigh-quality ePRO data. By the end of 2011, Sponsors andCROs will choose an ePRO System for their protocol—notjust the devices.PHT has a closed-loop controlled ePRO System thatcontinues to mature with quality management systemscertified ISO 9001:2008. This System integratesindependent testing teams, an internal, global StudySupport Center, certified Project Management and a ScienceTeam known for its PRO expertise. PHT continues to lead

6Call PHT for these FREE ePRO decision tools:PRO Selection Tool:• Which collection method for PRO data will best support your trial—Paper or ePRO? Electronic Patient-Reported Outcome (ePRO)Online ePRO Decision Tool: System Components• Which ePRO collection method will best support your protocol? LogPad System SitePad Tablet StudyWorks eSense™ Family of Integrated Medical Devices ePRO Designer Study Archive PROVision Scientific Services Trial Success Program™ (TSP) PHT Global Study Support CenterUS 1.877.360.2901 • EUR 41.22.879.91.00 Scientific Review and Validation Site Telecommunications Assessments1 GBI Research, ‘The Future of eClinical Trial Solutions – Market Forecasts to 2015,Competitive Benchmarking and Case Studies, pp53-54, December 2009. 2 U.S.Department of Health and Human Services, Food and Drug Administration, December2009. 3 European Medicines Agency, July 2005. 4 Other global regulatory agencies includethe Pharmaceuticals and Medical Devices Agency, Japan; European Union, the InternationalConference on Harmonization; and other country-specific government agencies.US HEADQUARTERS: EUROPEAN HEADQUARTERS:PHT Corporation PHT Corporation Sàrl www.phtcorp.com500 Rutherford Avenue 2, chemin Louis-Hubert Copyright © 2010 PHT CorporationBoston, MA 02129 USA 1213 Petit-Lancy, Geneva, Switzerland Rev 072010Toll-Free: US 1.877-360-2901 Phone: 41.22.879.91.00

5 Ways to Collect ePRO

by Chris Teel Hall

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