Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group.
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ABSTRACT:
SUBMITTER: EU-Response investigators group
PROVIDER: S-EPMC8572734 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
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Accelerating clinical trial implementation in the context of the COVID-19 pandemic: challenges, lessons learned and recommendations from DisCoVeRy and the EU-SolidAct EU response group.
Diallo Alpha A Trøseid Marius M Simensen Victoria Charlotte VC Boston Anaïs A Demotes Jacques J Olsen Inge Christoffer IC Chung Florence F Paiva José Artur JA Hites Maya M Ader Florence F Arribas Jose Ramon JR Baratt-Due Andreas A Melien Øyvind Ø Tacconelli Evelina E Staub Thèrèse T Greil Richard R Tsiodras Sotirios S Tsiodras Sotirios S Briel Matthias M Esperou Hélène H Mentré France F Eustace Joe J Saillard Juliette J Delmas Christelle C LeMestre Soizic S Dumousseaux Marina M Costagliola Dominique D Røttingen John-Arne JA Yazdanpanah Yazdan Y
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases 20211108 1
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Project description:BackgroundHemolytic uremic syndrome (HUS) is a rare condition which diagnosed with the triad of thrombocytopenia, microangiopathic hemolytic anemia, and acute renal injury. There is a high requirement for research to discover treatments. HUS registries can be used as an important information infrastructure. In this study, we identified and compared the different features of HUS registries to present a guide for the development and implementation of HUS registries.ResultsThe purposes of registries were classified as clinical (9 registries), research (7 registries), and epidemiological (5 registries), and only 3 registries pursued all three types of purposes. The data set included demographic data, medical and family history, para-clinical and diagnostic measures, treatment and pharmacological data, complications, and outcomes. The assessment strategies of data quality included monthly evaluation and data audit, the participation of physicians to collect data, editing and correcting data errors, increasing the rate of data completion, following guidelines and data quality training, using specific data quality indicators, and real-time evaluation of data at the time of data entry. 8 registries include atypical HUS patients, and 7 registries include all patients regardless of age. Only two registries focused on children. 4 registries apply prospective and 4 applied both prospective, and retrospective data collection. Finally, specialized hospitals were the main data source for these registries.ConclusionBased on the findings, we suggested a learning framework for developing and implementing an HUS registry. This framework includes lessons learned and suggestions for HUS registry purposes, minimum data set, data quality assurance, data collection methods, inclusion and exclusion criteria as well as data sources. This framework can help researchers develop HUS registries.
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