Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians
Abstract Background Statisticians are fundamental in ensuring clinical research, including clinical trials, are conducted with quality, transparency, reproducibility and integrity. Good Clinical Practice (GCP) is an international quality standard for the conduct of clinical trials research. Statisti...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-02-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-024-07940-1 |
| _version_ | 1797273301702148096 |
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| author | Deborah D. Stocken Helen Mossop Emma Armstrong Steff Lewis Susan J. Dutton Claire Peckitt Carrol Gamble Julia Brown |
| author_facet | Deborah D. Stocken Helen Mossop Emma Armstrong Steff Lewis Susan J. Dutton Claire Peckitt Carrol Gamble Julia Brown |
| author_sort | Deborah D. Stocken |
| collection | DOAJ |
| description | Abstract Background Statisticians are fundamental in ensuring clinical research, including clinical trials, are conducted with quality, transparency, reproducibility and integrity. Good Clinical Practice (GCP) is an international quality standard for the conduct of clinical trials research. Statisticians are required to undertake training on GCP but existing training is generic and, crucially, does not cover statistical activities. This results in statisticians undertaking training mostly unrelated to their role and variation in awareness and implementation of relevant regulatory requirements with regards to statistical conduct. The need for role-relevant training is recognised by the UK NHS Health Research Authority and the Medicines and Healthcare products Regulatory Agency (MHRA). Methods The Good Statistical Practice (GCP for Statisticians) project was instigated by the UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Unit (CTU) Statisticians Operational Group and funded by the National Institute for Health and Care Research (NIHR), to develop materials to enable role-specific GCP training tailored to statisticians. Review of current GCP training was undertaken by survey. Development of training materials were based on MHRA GCP. Critical review and piloting was conducted with UKCRC CTU and NIHR researchers with comment from MHRA. Final review was conducted through the UKCRC CTU Statistics group. Results The survey confirmed the need and desire for the development of dedicated GCP training for statisticians. An accessible, comprehensive, piloted training package was developed tailored to statisticians working in clinical research, particularly the clinical trials arena. The training materials cover legislation and guidance for best practice across all clinical trial processes with statistical involvement, including exercises and real-life scenarios to bridge the gap between theory and practice. Comprehensive feedback was incorporated. The training materials are freely available for national and international adoption. Conclusion All research staff should have training in GCP yet the training undertaken by most academic statisticians does not cover activities related to their role. The Good Statistical Practice (GCP for Statisticians) project has developed and extensively piloted new, role-specific, comprehensive, accessible GCP training tailored to statisticians working in clinical research, particularly the clinical trials arena. This role-specific training will encourage best practice, leading to transparent and reproducible statistical activity, as required by regulatory authorities and funders. |
| first_indexed | 2024-03-07T14:42:28Z |
| format | Article |
| id | doaj.art-25a6e37c4dd94360bb3911b8f946a0a4 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-07T14:42:28Z |
| publishDate | 2024-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-25a6e37c4dd94360bb3911b8f946a0a42024-03-05T20:10:58ZengBMCTrials1745-62152024-02-012511910.1186/s13063-024-07940-1Good Statistical Practice—development of tailored Good Clinical Practice training for statisticiansDeborah D. Stocken0Helen Mossop1Emma Armstrong2Steff Lewis3Susan J. Dutton4Claire Peckitt5Carrol Gamble6Julia Brown7Leeds Institute of Clinical Trials Research, Faculty of Medicine and Health, University of LeedsBiostatistics Research Group, Institute of Health and Society, Newcastle UniversityLeeds Institute of Clinical Trials Research, Faculty of Medicine and Health, University of LeedsEdinburgh Clinical Trials Unit, Usher Institute of Population Health Sciences and Informatics, University of EdinburghOxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of OxfordRoyal Marsden and Institute for Cancer Research Clinical Trials Units, The Royal Marsden NHS Foundation TrustLiverpool Clinical Trials Clinical Trials Research Centre, Department of Biostatistics, University of LiverpoolLeeds Institute of Clinical Trials Research, Faculty of Medicine and Health, University of LeedsAbstract Background Statisticians are fundamental in ensuring clinical research, including clinical trials, are conducted with quality, transparency, reproducibility and integrity. Good Clinical Practice (GCP) is an international quality standard for the conduct of clinical trials research. Statisticians are required to undertake training on GCP but existing training is generic and, crucially, does not cover statistical activities. This results in statisticians undertaking training mostly unrelated to their role and variation in awareness and implementation of relevant regulatory requirements with regards to statistical conduct. The need for role-relevant training is recognised by the UK NHS Health Research Authority and the Medicines and Healthcare products Regulatory Agency (MHRA). Methods The Good Statistical Practice (GCP for Statisticians) project was instigated by the UK Clinical Research Collaboration (UKCRC) Registered Clinical Trials Unit (CTU) Statisticians Operational Group and funded by the National Institute for Health and Care Research (NIHR), to develop materials to enable role-specific GCP training tailored to statisticians. Review of current GCP training was undertaken by survey. Development of training materials were based on MHRA GCP. Critical review and piloting was conducted with UKCRC CTU and NIHR researchers with comment from MHRA. Final review was conducted through the UKCRC CTU Statistics group. Results The survey confirmed the need and desire for the development of dedicated GCP training for statisticians. An accessible, comprehensive, piloted training package was developed tailored to statisticians working in clinical research, particularly the clinical trials arena. The training materials cover legislation and guidance for best practice across all clinical trial processes with statistical involvement, including exercises and real-life scenarios to bridge the gap between theory and practice. Comprehensive feedback was incorporated. The training materials are freely available for national and international adoption. Conclusion All research staff should have training in GCP yet the training undertaken by most academic statisticians does not cover activities related to their role. The Good Statistical Practice (GCP for Statisticians) project has developed and extensively piloted new, role-specific, comprehensive, accessible GCP training tailored to statisticians working in clinical research, particularly the clinical trials arena. This role-specific training will encourage best practice, leading to transparent and reproducible statistical activity, as required by regulatory authorities and funders.https://doi.org/10.1186/s13063-024-07940-1Good clinical practiceGood statistical practiceClinical research |
| spellingShingle | Deborah D. Stocken Helen Mossop Emma Armstrong Steff Lewis Susan J. Dutton Claire Peckitt Carrol Gamble Julia Brown Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians Trials Good clinical practice Good statistical practice Clinical research |
| title | Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians |
| title_full | Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians |
| title_fullStr | Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians |
| title_full_unstemmed | Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians |
| title_short | Good Statistical Practice—development of tailored Good Clinical Practice training for statisticians |
| title_sort | good statistical practice development of tailored good clinical practice training for statisticians |
| topic | Good clinical practice Good statistical practice Clinical research |
| url | https://doi.org/10.1186/s13063-024-07940-1 |
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