Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial

Detalhes bibliográficos
Autor(a) principal: Hanscom, Brett S.
Data de Publicação: 2022
Outros Autores: Donnell, Deborah J., Fleming, Thomas R., Hughes, James P., McCauley, Marybeth, Grinsztejn, Beatriz, Landovitz, Raphael J., Emerson, Scott S.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/56183
Resumo: Fred Hutchinson Cancer Research Center. Statistical Center for HIV Research and Prevention. Seattle, WA, USA.
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spelling Hanscom, Brett S.Donnell, Deborah J.Fleming, Thomas R.Hughes, James P.McCauley, MarybethGrinsztejn, BeatrizLandovitz, Raphael J.Emerson, Scott S.2022-12-22T18:28:14Z2022-12-22T18:28:14Z2022HANSCOM, Brett S. et al. Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial. Clinical trials, v. 19, n. 6, p. 605-612, 2022.1740-7745https://www.arca.fiocruz.br/handle/icict/5618310.1177/17407745221118371engEvaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trialinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleFred Hutchinson Cancer Research Center. Statistical Center for HIV Research and Prevention. Seattle, WA, USA.Fred Hutchinson Cancer Research Center. Statistical Center for HIV Research and Prevention. Seattle, WA, USA.University of Washington. Department of Biostatistics. Hans Rosling Center for Population Health. Seattle, WA, USA.Fred Hutchinson Cancer Research Center. Statistical Center for HIV Research and Prevention. Seattle, WA, USA / University of Washington. Department of Biostatistics. Hans Rosling Center for Population Health. Seattle, WA, USA.FHI 360. Durham, NC, USA.Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Laboratório de Pesquisa Clínica em DST/AIDS. Rio de Janeiro, RJ, Brasil.UCLA Center for Clinical AIDS Research and Education. Los Angeles, CA, USA.University of Washington. Department of Biostatistics. Hans Rosling Center for Population Health. Seattle, WA, USA.Background/aims: The HIV Prevention Trials Network 083 trial was a group-sequential non-inferiority trial designed to compare HIV incidence under a novel experimental regimen for HIV prevention, long-acting injectable cabotegravir, with an active-control regimen of daily oral tenofovir disoproxil fumarate/emtricitabine (brand name Truvada). In March of 2020, just as the trial had completed enrollment, the COVID-19 pandemic threatened to prevent trial participants from attending study visits and obtaining study medication, motivating the study team to update the interim monitoring plan. The Data and Safety Monitoring Board subsequently stopped the trial at the first interim review due to strong early evidence of efficacy. Methods: Here we describe some unique aspects of the trial's design, monitoring, analysis, and interpretation. We illustrate the importance of computing point estimates, confidence intervals, and p values based on the sampling distribution induced by sequential monitoring. Results: Accurate analysis, decision-making and interpretation of trial results rely on pre-specification of a stopping boundary, including the scale on which the stopping rule will be implemented, the specific test statistics to be calculated, and how the boundary will be adjusted if the available information fraction at interim review is different from planned. After appropriate adjustment for the sampling distribution and overrun, the HIV Prevention Trials Network 083 trial provided strong evidence that the experimental regimen was superior to the active control. Conclusions: For the HIV Prevention Trials Network 083 trial, the difference between corrected inferential statistics and naive results was quite small-as will often be the case-nevertheless, it is appropriate to report and publish the most accurate and unbiased statistical results.Group-sequential trialsHPTN 083Early stoppingNon-inferiorityinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/56183/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALEvaluating_Beatriz_Grionsztejn_etal_INI_2022.pdfEvaluating_Beatriz_Grionsztejn_etal_INI_2022.pdfapplication/pdf602281https://www.arca.fiocruz.br/bitstream/icict/56183/2/Evaluating_Beatriz_Grionsztejn_etal_INI_2022.pdff4d1e4540951ce8a0ef33d1d8131db5eMD52icict/561832022-12-22 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dc.title.en_US.fl_str_mv Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial
title Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial
spellingShingle Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial
Hanscom, Brett S.
Group-sequential trials
HPTN 083
Early stopping
Non-inferiority
title_short Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial
title_full Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial
title_fullStr Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial
title_full_unstemmed Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial
title_sort Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial
author Hanscom, Brett S.
author_facet Hanscom, Brett S.
Donnell, Deborah J.
Fleming, Thomas R.
Hughes, James P.
McCauley, Marybeth
Grinsztejn, Beatriz
Landovitz, Raphael J.
Emerson, Scott S.
author_role author
author2 Donnell, Deborah J.
Fleming, Thomas R.
Hughes, James P.
McCauley, Marybeth
Grinsztejn, Beatriz
Landovitz, Raphael J.
Emerson, Scott S.
author2_role author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Hanscom, Brett S.
Donnell, Deborah J.
Fleming, Thomas R.
Hughes, James P.
McCauley, Marybeth
Grinsztejn, Beatriz
Landovitz, Raphael J.
Emerson, Scott S.
dc.subject.en.en_US.fl_str_mv Group-sequential trials
HPTN 083
Early stopping
Non-inferiority
topic Group-sequential trials
HPTN 083
Early stopping
Non-inferiority
description Fred Hutchinson Cancer Research Center. Statistical Center for HIV Research and Prevention. Seattle, WA, USA.
publishDate 2022
dc.date.accessioned.fl_str_mv 2022-12-22T18:28:14Z
dc.date.available.fl_str_mv 2022-12-22T18:28:14Z
dc.date.issued.fl_str_mv 2022
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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status_str publishedVersion
dc.identifier.citation.fl_str_mv HANSCOM, Brett S. et al. Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial. Clinical trials, v. 19, n. 6, p. 605-612, 2022.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/56183
dc.identifier.issn.en_US.fl_str_mv 1740-7745
dc.identifier.doi.none.fl_str_mv 10.1177/17407745221118371
identifier_str_mv HANSCOM, Brett S. et al. Evaluating group-sequential non-inferiority clinical trials following interim stopping: The HIV Prevention Trials Network 083 trial. Clinical trials, v. 19, n. 6, p. 605-612, 2022.
1740-7745
10.1177/17407745221118371
url https://www.arca.fiocruz.br/handle/icict/56183
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
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instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/56183/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/56183/2/Evaluating_Beatriz_Grionsztejn_etal_INI_2022.pdf
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