Jodi Smith-Gick1, Nicola Barnes2, Rocco Barone3, Jeff Bedford4, Jason R James5, Stacy Frankovitz Reisner6, Michael Stephenson7. 1. 1 Eli Lilly and Company, Indianapolis, IN, USA. 2. 2 Pfizer, Sandwich, Kent, NJ United Kingdom. 3. 3 Merck & Co., Inc, Kenilworth, NJ, USA. 4. 4 GlaxoSmithKline, Collegeville, PA, USA. 5. 5 Bristol Myers Squibb, Moreton, Wirral, United Kingdom. 6. 6 Genentech, a Member of the Roche Group, South San Francisco, CA, USA. 7. 7 Janssen Pharmaceutica NV, Belgium.
Abstract
BACKGROUND: Current clinical trial labels are designed primarily to meet regulatory requirements. These labels have low patient and site utility, few are opened, and they have limited space and small fonts. As our world transitions from paper to electronic, an opportunity exists to provide patients with information about their investigational clinical trial product in a way that is more easily accessible, meets Health Authority requirements, and provides valuable additional information for the patient and caregiver. METHODS: A TransCelerate initiative was launched to understand the current regulatory and technology landscape for the potential use an electronic label (eLabel) for investigational medicinal products (IMPs). Concepts and an example proof of concept were developed intended to show the "art of the possible" for a foundational eLabel and a "universal printed label." In addition, possible patient-centric enhancements were captured in the eLabel proof of concept. These concepts were shared with Health Authorities as well as patient and site advisory groups to gather feedback and subsequently enhance the concepts. RESULTS: Feedback indicated that the concept of an eLabel provides value and concepts should continue to be pursued. While the Health Authorities engaged with did not express issues with the use of an eLabel per se, the reduction in the content on the paper label is not possible in some geographic locations due to existing regulations. CONCLUSIONS: There is nothing that prevents transmitting the label electronically in conjunction with current conventional labeling. While there are still some regulatory barriers that need to be addressed for reducing what is on the paper label, advancement toward a more patient-centric approach benefits stakeholders and will enable a fully connected patient-centric experience. The industry must start now to build the foundation.
BACKGROUND: Current clinical trial labels are designed primarily to meet regulatory requirements. These labels have low patient and site utility, few are opened, and they have limited space and small fonts. As our world transitions from paper to electronic, an opportunity exists to provide patients with information about their investigational clinical trial product in a way that is more easily accessible, meets Health Authority requirements, and provides valuable additional information for the patient and caregiver. METHODS: A TransCelerate initiative was launched to understand the current regulatory and technology landscape for the potential use an electronic label (eLabel) for investigational medicinal products (IMPs). Concepts and an example proof of concept were developed intended to show the "art of the possible" for a foundational eLabel and a "universal printed label." In addition, possible patient-centric enhancements were captured in the eLabel proof of concept. These concepts were shared with Health Authorities as well as patient and site advisory groups to gather feedback and subsequently enhance the concepts. RESULTS: Feedback indicated that the concept of an eLabel provides value and concepts should continue to be pursued. While the Health Authorities engaged with did not express issues with the use of an eLabel per se, the reduction in the content on the paper label is not possible in some geographic locations due to existing regulations. CONCLUSIONS: There is nothing that prevents transmitting the label electronically in conjunction with current conventional labeling. While there are still some regulatory barriers that need to be addressed for reducing what is on the paper label, advancement toward a more patient-centric approach benefits stakeholders and will enable a fully connected patient-centric experience. The industry must start now to build the foundation.
Authors: Winona Rei R Bolislis; Charlie Mortazavi; Rossana Riccioni; Paul-Etienne Schaeffer; Thomas C Kühler Journal: Ther Innov Regul Sci Date: 2019-12-09 Impact factor: 1.778