ePro and Diabetes
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Diabetes clinical research often includes PROs to measure symptoms and safety, evaluate quality of life, and record the economic burden. This edition of Insights highlights the conversion from paper to PRO for a PRO instrument designed to assess the impact of diabetes on the quality of life of patients with diabetes.
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FDA PRO Final Guidance v Draft Version
The purpose of this article is to provide Sponsors and CROs with a point-by-point review
of the differences between the Final FDA PRO Guidance and the Draft, highlighting the
choices made by FDA during the 3 years following the Draft PRO Guidance. These choices
reveal the FDA deliberations and resulting emphasis, and we also suggest in our review
what some of the differences might imply. Note that where terms appear highlighted
or emphasized in quotes from the Final Guidance, the emphasis has been done in the
original FDA document.
How to Justify ePRO
Trials with patient reported endpoints are reporting increased efficiencies when using electronic patient reported outcomes (ePRO), compared to paper diary data collection methods. To date, approximately 20% of all trials with patient reported endpoints are using ePRO solutions to collect efficacy data. As the adoption of electronic patient reported outcomes continues to increase, sponsors are finding new ways to justify this technology’s ROI, and identify the types of trials that are best suited to ePRO (versus paper). This article will describe how several market-leading sponsors have quantified the benefits of better data quality, with case examples from recent trials implemented by PHT Corporation (PHT). These analyses are provided with the intention to inform the clinical research community, and provide the frameworks for further ROI determinations.
Collecting ePRO Online
The proliferation and global adoption of the Web is prompting biopharmaceutical decision makers to ask how the Internet can be leveraged to expedite clinical trials. It is reasonable to presume that large populations of patients are Web-savvy and that they have Internet access. As such, it is possible to leverage the Web as a mode of administration for entering electronic patient reported outcome data for clinical research. A key question many sponsors are asking is can the Web be used to collect patient reported outcomes that support label claims?
This article will describe the browser-based electronic patient reported outcome (ePRO) collection method. It will explain which types of trials are best suited for this type of data collection; discuss psychometric validations required with this collection modality; and explain how and when ePRO data collected via the web can support a claim.
ePRO: Objective Patient Data Collection
This issue includes an article entitled PHT Auditing, featuring Rod Thorell, Director of Quality Management & Compliance at PHT Corporation; an interview entitled Why Auditing is Critical to Sponsors with Laura Araujo, a Senior Consultant of Quality Management at Halloran Consulting Group; and a brief Question/Answer segment with Rod that reviews the contemporary issues of auditing, and explains what sponsors commonly ask of PHT’s auditing processes and procedures.
Recommended
FDA PRO Final Guidance v Draft Version
The purpose of this article is to provide Sponsors and CROs with a point-by-point review
of the differences between the Final FDA PRO Guidance and the Draft, highlighting the
choices made by FDA during the 3 years following the Draft PRO Guidance. These choices
reveal the FDA deliberations and resulting emphasis, and we also suggest in our review
what some of the differences might imply. Note that where terms appear highlighted
or emphasized in quotes from the Final Guidance, the emphasis has been done in the
original FDA document.
How to Justify ePRO
Trials with patient reported endpoints are reporting increased efficiencies when using electronic patient reported outcomes (ePRO), compared to paper diary data collection methods. To date, approximately 20% of all trials with patient reported endpoints are using ePRO solutions to collect efficacy data. As the adoption of electronic patient reported outcomes continues to increase, sponsors are finding new ways to justify this technology’s ROI, and identify the types of trials that are best suited to ePRO (versus paper). This article will describe how several market-leading sponsors have quantified the benefits of better data quality, with case examples from recent trials implemented by PHT Corporation (PHT). These analyses are provided with the intention to inform the clinical research community, and provide the frameworks for further ROI determinations.
Collecting ePRO Online
The proliferation and global adoption of the Web is prompting biopharmaceutical decision makers to ask how the Internet can be leveraged to expedite clinical trials. It is reasonable to presume that large populations of patients are Web-savvy and that they have Internet access. As such, it is possible to leverage the Web as a mode of administration for entering electronic patient reported outcome data for clinical research. A key question many sponsors are asking is can the Web be used to collect patient reported outcomes that support label claims?
This article will describe the browser-based electronic patient reported outcome (ePRO) collection method. It will explain which types of trials are best suited for this type of data collection; discuss psychometric validations required with this collection modality; and explain how and when ePRO data collected via the web can support a claim.
ePRO: Objective Patient Data Collection
This issue includes an article entitled PHT Auditing, featuring Rod Thorell, Director of Quality Management & Compliance at PHT Corporation; an interview entitled Why Auditing is Critical to Sponsors with Laura Araujo, a Senior Consultant of Quality Management at Halloran Consulting Group; and a brief Question/Answer segment with Rod that reviews the contemporary issues of auditing, and explains what sponsors commonly ask of PHT’s auditing processes and procedures.
eSource Data and ePRO
Electronic Source (eSource) Data: Defined and Interpreted by Global Regulatory Authorities
Two recent regulatory publications from FDA and EMA address the topic of electronic source data in clinical investigations.
While the views are slightly different, these documents provide clarity concerning the expectations of regulatory authorities regarding electronic source data.
This Issue explores the topic of electronic source data and identifies some key concepts that are common (and seemingly agreed upon) within these publications.
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Sponsors and regulators rely on the ePRO archive to prove that trial data are attributable and accurate; and that the trial can be reconstructed at any time. Any omissions can risk regulatory warnings, findings and possible data rejection. This issue describes the PTH ePRO Archive, and explains how and why it exceeds regulatory requirements and industry guidelines.
FDA PRO Guidance
The PRO Final Guidance announced December 2009 helps Sponsors and CROs understand how to include the patient viewpoint in the clinical trials that support market authorization for their medical products. The Guidance shows that FDA understands the pivotal role of PRO measures in establishing clinical benefit. This Insights edition is dedicated to ePRO mentioned within the Final Guidance, and intended to provide readers with an executive summary of the new document with respect to ePRO.
How to Safeguard ePRO
Sponsors and CROs must be assured that clinical data collected for regulatory submissions comply with the regulations and guidance around the world for data quality and integrity. Regulatory agencies are placing more emphasis on the voice of the patient, and they are auditing patient reported data for validity and trustworthiness. Intuitively, capturing patient data electronically instead of on paper would seem capable of providing valid data more reliably and efficiently. PHT has demonstrated that this is true.
When ePRO
The importance of learning how patients feel and function when taking a new clinical therapy has been acknowledged by the FDA, EMA and other global regulatory authorities. Sponsors currently engaged in drug development programs appreciate and leverage the added value of patient-reported outcome (PRO) data. They no longer ask if PROs should be collected, but what phase to begin PRO collection.
This issue of Insights is intended to identify the costs (delays and expenses) of collecting patient-reported outcomes on paper; and compare these against electronic PRO capture. The intention of this issue to provide clinical teams with industry data that can refute the presumption that paper methods are cheaper than ePRO.
5 Ways to Collect ePRO
The specialized industry of collecting electronic patient-reported outcomes is increasing linearly, in part because global government regulators want to hear directly from the patient, and because the acceleration and availability of electronic collection (vs. paper collection) improves data quality and efficiencies for data analysis and trial management. This document will review the ePRO market, and outline the five ePRO methods what successfully support the collection of patient-reported data
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Electronic Source (eSource) Data: Defined and Interpreted by Global Regulatory Authorities
Two recent regulatory publications from FDA and EMA address the topic of electronic source data in clinical investigations.
While the views are slightly different, these documents provide clarity concerning the expectations of regulatory authorities regarding electronic source data.
This Issue explores the topic of electronic source data and identifies some key concepts that are common (and seemingly agreed upon) within these publications.
Changing Paradigms - The Evolution of Experiential Production
360e Productions' Founder and President, Chris Schultenover, was invited to participate in an Executive Briefing with Event Marketer entitled "Changing Paradigms - The Evolution of Experiential Production."
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Sponsors and regulators rely on the ePRO archive to prove that trial data are attributable and accurate; and that the trial can be reconstructed at any time. Any omissions can risk regulatory warnings, findings and possible data rejection. This issue describes the PTH ePRO Archive, and explains how and why it exceeds regulatory requirements and industry guidelines.
FDA PRO Guidance
The PRO Final Guidance announced December 2009 helps Sponsors and CROs understand how to include the patient viewpoint in the clinical trials that support market authorization for their medical products. The Guidance shows that FDA understands the pivotal role of PRO measures in establishing clinical benefit. This Insights edition is dedicated to ePRO mentioned within the Final Guidance, and intended to provide readers with an executive summary of the new document with respect to ePRO.
How to Safeguard ePRO
Sponsors and CROs must be assured that clinical data collected for regulatory submissions comply with the regulations and guidance around the world for data quality and integrity. Regulatory agencies are placing more emphasis on the voice of the patient, and they are auditing patient reported data for validity and trustworthiness. Intuitively, capturing patient data electronically instead of on paper would seem capable of providing valid data more reliably and efficiently. PHT has demonstrated that this is true.
When ePRO
The importance of learning how patients feel and function when taking a new clinical therapy has been acknowledged by the FDA, EMA and other global regulatory authorities. Sponsors currently engaged in drug development programs appreciate and leverage the added value of patient-reported outcome (PRO) data. They no longer ask if PROs should be collected, but what phase to begin PRO collection.
This issue of Insights is intended to identify the costs (delays and expenses) of collecting patient-reported outcomes on paper; and compare these against electronic PRO capture. The intention of this issue to provide clinical teams with industry data that can refute the presumption that paper methods are cheaper than ePRO.
5 Ways to Collect ePRO
The specialized industry of collecting electronic patient-reported outcomes is increasing linearly, in part because global government regulators want to hear directly from the patient, and because the acceleration and availability of electronic collection (vs. paper collection) improves data quality and efficiencies for data analysis and trial management. This document will review the ePRO market, and outline the five ePRO methods what successfully support the collection of patient-reported data
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