Guidelines for the content of statistical analysis plans in clinical trials
While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility.To develop recommendations for a minimum set of items that should be addressed in SAPs f...
| المؤلفون الرئيسيون: | , , , , , , , , , , , , , , |
|---|---|
| التنسيق: | Journal article |
| اللغة: | English |
| منشور في: |
American Medical Association
2017
|
| _version_ | 1826279795295518720 |
|---|---|
| author | Gamble, C Krishan, A Stocken, D Lewis, S Juszczak, E Doré, C Williamson, P Altman, D Montgomery, A Lim, P Berlin, J Senn, S Day, S Barbachano, Y Loder, E |
| author_facet | Gamble, C Krishan, A Stocken, D Lewis, S Juszczak, E Doré, C Williamson, P Altman, D Montgomery, A Lim, P Berlin, J Senn, S Day, S Barbachano, Y Loder, E |
| author_sort | Gamble, C |
| collection | OXFORD |
| description | While guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility.To develop recommendations for a minimum set of items that should be addressed in SAPs for clinical trials, developed with input from statisticians, previous guideline authors, journal editors, regulators, and funders.Funders and regulators (n = 39) of randomized trials were contacted and the literature was searched to identify existing guidance; a survey of current practice was conducted across the network of UK Clinical Research Collaboration-registered trial units (n = 46, 1 unit had 2 responders) and a Delphi survey (n = 73 invited participants) was conducted to establish consensus on SAPs. The Delphi survey was sent to statisticians in trial units who completed the survey of current practice (n = 46), CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guideline authors (n = 16), pharmaceutical industry statisticians (n = 3), journal editors (n = 9), and regulators (n = 2) (3 participants were included in 2 groups each), culminating in a consensus meeting attended by experts (N = 12) with representatives from each group. The guidance subsequently underwent critical review by statisticians from the surveyed trial units and members of the expert panel of the consensus meeting (N = 51), followed by piloting of the guidance document in the SAPs of 5 trials.No existing guidance was identified. The registered trials unit survey (46 responses) highlighted diversity in current practice and confirmed support for developing guidance. The Delphi survey (54 of 73, 74% participants completing both rounds) reached consensus on 42% (n = 46) of 110 items. The expert panel (N = 12) agreed that 63 items should be included in the guidance, with an additional 17 items identified as important but may be referenced elsewhere. Following critical review and piloting, some overlapping items were combined, leaving 55 items.Recommendations are provided for a minimum set of items that should be addressed and included in SAPs for clinical trials. Trial registration, protocols, and statistical analysis plans are critically important in ensuring appropriate reporting of clinical trials. |
| first_indexed | 2024-03-07T00:04:07Z |
| format | Journal article |
| id | oxford-uuid:76f5b5d0-e2b8-4cec-a67f-4f27e9f02d7b |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T00:04:07Z |
| publishDate | 2017 |
| publisher | American Medical Association |
| record_format | dspace |
| spelling | oxford-uuid:76f5b5d0-e2b8-4cec-a67f-4f27e9f02d7b2022-03-26T20:19:57ZGuidelines for the content of statistical analysis plans in clinical trialsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:76f5b5d0-e2b8-4cec-a67f-4f27e9f02d7bEnglishSymplectic Elements at OxfordAmerican Medical Association2017Gamble, CKrishan, AStocken, DLewis, SJuszczak, EDoré, CWilliamson, PAltman, DMontgomery, ALim, PBerlin, JSenn, SDay, SBarbachano, YLoder, EWhile guidance on statistical principles for clinical trials exists, there is an absence of guidance covering the required content of statistical analysis plans (SAPs) to support transparency and reproducibility.To develop recommendations for a minimum set of items that should be addressed in SAPs for clinical trials, developed with input from statisticians, previous guideline authors, journal editors, regulators, and funders.Funders and regulators (n = 39) of randomized trials were contacted and the literature was searched to identify existing guidance; a survey of current practice was conducted across the network of UK Clinical Research Collaboration-registered trial units (n = 46, 1 unit had 2 responders) and a Delphi survey (n = 73 invited participants) was conducted to establish consensus on SAPs. The Delphi survey was sent to statisticians in trial units who completed the survey of current practice (n = 46), CONSORT (Consolidated Standards of Reporting Trials) and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guideline authors (n = 16), pharmaceutical industry statisticians (n = 3), journal editors (n = 9), and regulators (n = 2) (3 participants were included in 2 groups each), culminating in a consensus meeting attended by experts (N = 12) with representatives from each group. The guidance subsequently underwent critical review by statisticians from the surveyed trial units and members of the expert panel of the consensus meeting (N = 51), followed by piloting of the guidance document in the SAPs of 5 trials.No existing guidance was identified. The registered trials unit survey (46 responses) highlighted diversity in current practice and confirmed support for developing guidance. The Delphi survey (54 of 73, 74% participants completing both rounds) reached consensus on 42% (n = 46) of 110 items. The expert panel (N = 12) agreed that 63 items should be included in the guidance, with an additional 17 items identified as important but may be referenced elsewhere. Following critical review and piloting, some overlapping items were combined, leaving 55 items.Recommendations are provided for a minimum set of items that should be addressed and included in SAPs for clinical trials. Trial registration, protocols, and statistical analysis plans are critically important in ensuring appropriate reporting of clinical trials. |
| spellingShingle | Gamble, C Krishan, A Stocken, D Lewis, S Juszczak, E Doré, C Williamson, P Altman, D Montgomery, A Lim, P Berlin, J Senn, S Day, S Barbachano, Y Loder, E Guidelines for the content of statistical analysis plans in clinical trials |
| title | Guidelines for the content of statistical analysis plans in clinical trials |
| title_full | Guidelines for the content of statistical analysis plans in clinical trials |
| title_fullStr | Guidelines for the content of statistical analysis plans in clinical trials |
| title_full_unstemmed | Guidelines for the content of statistical analysis plans in clinical trials |
| title_short | Guidelines for the content of statistical analysis plans in clinical trials |
| title_sort | guidelines for the content of statistical analysis plans in clinical trials |
| work_keys_str_mv | AT gamblec guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT krishana guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT stockend guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT lewiss guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT juszczake guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT dorec guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT williamsonp guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT altmand guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT montgomerya guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT limp guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT berlinj guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT senns guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT days guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT barbachanoy guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials AT lodere guidelinesforthecontentofstatisticalanalysisplansinclinicaltrials |