Contributions
Abstract: 21
Type: Hot Topic
Abstract Category: N/A
Patient-reported outcomes (PROs) are important means of evaluating the treatment benefit of drugs and other medical interventions. In the past, PROs could be implemented much more easily in clinical care as there are an increased use of modern measurement methods in PRO design and validation, a rapid progression of technology (eg, touchscreen tablets, Internet accessibility, and electronic health records), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations.
The movement from paper-based to electronic PRO (ePRO) data capture has enhanced the integrity and accuracy of clinical trial data and is encouraged by regulators and payers. Outcomes research literature demonstrated a lot of examples of high-quality, reliable ePRO data entered directly by electronic means compared to data entered from original results on paper. Regarding hardware of ePRO platforms, telephone-based interactive voice response systems can be differentiated from screen-based systems. Touchscreen-based devices have become the main tool for ePRO collection in clinical trials. Although study subjects can be provided with such a device with its proprietary software program, the patient´s own internet-enabled mobile device is used (bring your own device (BYOD)) using a downloadable app or a Web-based data collection portal. However, a number of scientific and operational issues have to be addressed before BYOD can be routinely considered as a practical alternative. Regulatory review is crucial for the ePRO data collection for medical label claims, the evidence of the validation of these electronic data collection systems is key factor. There are well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. However, there are also emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. Nevertheless, the future for ePRO data collection is bright and the promise of BYOD opens a new chapter in its evolution.
Disclosure: Professor Ziemssen has received personal compensation for participating on advisory boards, trial steering committees and data and safety monitoring committees, as well as for scientific talks and project support from: Almirall, Bayer, BAT, Biogen, Celgene, Merck, Novartis, Roche, Sanofi and Teva.
Abstract: 21
Type: Hot Topic
Abstract Category: N/A
Patient-reported outcomes (PROs) are important means of evaluating the treatment benefit of drugs and other medical interventions. In the past, PROs could be implemented much more easily in clinical care as there are an increased use of modern measurement methods in PRO design and validation, a rapid progression of technology (eg, touchscreen tablets, Internet accessibility, and electronic health records), and greater demand for measurement and monitoring of PROs by regulators, payers, accreditors, and professional organizations.
The movement from paper-based to electronic PRO (ePRO) data capture has enhanced the integrity and accuracy of clinical trial data and is encouraged by regulators and payers. Outcomes research literature demonstrated a lot of examples of high-quality, reliable ePRO data entered directly by electronic means compared to data entered from original results on paper. Regarding hardware of ePRO platforms, telephone-based interactive voice response systems can be differentiated from screen-based systems. Touchscreen-based devices have become the main tool for ePRO collection in clinical trials. Although study subjects can be provided with such a device with its proprietary software program, the patient´s own internet-enabled mobile device is used (bring your own device (BYOD)) using a downloadable app or a Web-based data collection portal. However, a number of scientific and operational issues have to be addressed before BYOD can be routinely considered as a practical alternative. Regulatory review is crucial for the ePRO data collection for medical label claims, the evidence of the validation of these electronic data collection systems is key factor. There are well-designed electronic systems, including response automation, tailoring of item selection and reporting algorithms, flexibility of collection location, and integration with patient health care data elements. However, there are also emerging logistical barriers in this area, such as the need for specialized technological and methodological expertise, and design limitations of current electronic data capture systems. Nevertheless, the future for ePRO data collection is bright and the promise of BYOD opens a new chapter in its evolution.
Disclosure: Professor Ziemssen has received personal compensation for participating on advisory boards, trial steering committees and data and safety monitoring committees, as well as for scientific talks and project support from: Almirall, Bayer, BAT, Biogen, Celgene, Merck, Novartis, Roche, Sanofi and Teva.