International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials Editorial
| Authors: | Brady, K. J.; Peipert, J. D.; Atkinson, T. M.; Pompili, C.; Pinto, M.; Shaw, J. W.; Roydhouse, J.; on behalf of The International Society for Quality of Life Research Clinical Practice Special Interest Group; the International Society for Quality of Life Research Clinical Practice Special Interest Group; the International Society for Quality of Life Research Regulatory Health, Technology Assessment Engagement Special Interest Group; the International Society for Quality of Life Research Psychometrics Special Interest Group |
| Title: | International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials |
| Abstract: | In June 2021, the US Food and Drug Administration (FDA) released a draft guidance for industry on core patient-reported outcomes (PROs) and related considerations for instrument selection and trial design in registrational cancer clinical trials, building on prior communications about the use of PROs to assess efficacy and tolerability in oncology drug development. The International Society for Quality of Life Research (ISOQOL) Standards and Best Practices Committee led an initiative to draft a commentary about the guidance, focusing on its positive aspects and areas that would benefit from additional clarification and consideration. For comprehensiveness, the authors reviewed existing public comments on the draft guidance, and the commentary underwent a thorough review process through three ISOQOL Special Interest Groups (Psychometrics, Clinical Practice, and Regulatory and Health Technology Assessment Engagement) followed by the ISOQOL Board. The goal of this commentary is to situate this new and relevant guidance document within the context of recent regulatory efforts on PROs and highlight areas in which further work may ultimately benefit the field. (PsycInfo Database Record (c) 2023 APA, all rights reserved) |
| Keywords: | oncology; patient-reported outcomes; trial; guidance; clinical outcome assessment |
| Journal Title: | Quality of Life Research |
| Volume: | 32 |
| Issue: | 8 |
| ISSN: | 0962-9343 |
| Publisher: | Springer |
| Date Published: | 2023-08-01 |
| Start Page: | 2155 |
| End Page: | 2163 |
| ACCESSION: | 2023-76099-001 |
| DOI: | 10.1007/s11136-023-03396-z |
| PROVIDER: | Ovid Technologies |
| PROVIDER: | psycinfo |
| PMCID: | PMC10202747 |
| PUBMED: | 37217665 |
| DOI/URL: | |
| Notes: | The MSK Cancer Center Support Grant (P30 CA008748) is acknowledged in the PubMed record and PDF. Corresponding author is MSK author Thomas M. Atkinson -- Source: APA PsycInfo |
