Incompletely Reported Important Methodological Details and Inaccurate Description of the Formulation That the Control Arms Received in a Gardasil Vaccine Trial

Florence Bourgeois; Peter Doshi; Kyungwan Hong; Tom Jefferson; Mark Jones; Haeyoung Lee; Anisa Rowhani-Farid; Larissa Shamseer; O’Mareen M. Spence

doi:10.1128/mSphere.00770-20

Incompletely Reported Important Methodological Details and Inaccurate Description of the Formulation That the Control Arms Received in a Gardasil Vaccine Trial

Florence Bourgeois, Peter Doshi^*, Kyungwan Hong, Tom Jefferson, Mark Jones, Haeyoung Lee, Anisa Rowhani-Farid, Larissa Shamseer, O’Mareen M. Spence

^*Corresponding author for this work

Institute for Evidence-Based Healthcare

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Original language	English
Pages (from-to)	1-3
Number of pages	3
Journal	mSphere
Volume	5
Issue number	6
DOIs	https://doi.org/10.1128/mSphere.00770-20
Publication status	Published - 2020

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Incompletely Reported Important Methodological Details and Inaccurate Description of the Formulation That the Control Arms Received in a Gardasil Vaccine TrialFinal published version, 200 KBLicence: CC BY

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@article{071d525e2ea94f2fa71d7623d97e97a0,

title = "Incompletely Reported Important Methodological Details and Inaccurate Description of the Formulation That the Control Arms Received in a Gardasil Vaccine Trial",

author = "Florence Bourgeois and Peter Doshi and Kyungwan Hong and Tom Jefferson and Mark Jones and Haeyoung Lee and Anisa Rowhani-Farid and Larissa Shamseer and Spence, {O{\textquoteright}Mareen M.}",

note = "Funding Information: Florence Bourgeois{\textquoteright} work is supported by a grant from the Burroughs Wellcome Fund and by the Harvard-MIT Center for Regulatory Science. The Laura and John Arnold Foundation funds the RIAT Support Center, which supports the salaries of Peter Doshi (P.D.), Kyungwan Hong (K.H.), Mark Jones (M.J.), Tom Jefferson (T.J.), and Anisa Rowhani-Farid (A.R.-F.). In addition, P.D. has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018) and grants from the Laura and John Arnold Foundation (2017–21), American Association of Colleges of Pharmacy (2015), Patient-Centered Outcomes Research Institute (2014 –16), Cochrane Methods Innovations Fund (2016 –18), and UK National Institute for Health Research (2011–14) and is an editor at The BMJ and unpaid member of the Reagan-Udall Foundation for the FDA. K.H. received the Maryland CERSI Scholar award from the Food and Drug Administration (grant 5U01FD005946-04). M.J. reports research funds from the Cochrane Methods Innovation Fund to assist with providing interim guidance on the inclusion of clinical study reports and other regulatory documents in Cochrane Reviews. He is also deputy coordinating editor for the Cochrane Acute Respiratory Infections Group. T.J. was in receipt of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane Reviews (2015–2018). In 2014 to 2016, T.J. was a member of three advisory boards for Boehringer Ingelheim. T.J. is occasionally interviewed by market research companies about phase I or II pharmaceutical products for which he receives fees (current). T.J. was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine (2015–2017). T.J. is a relator in a False Claims Act lawsuit on behalf of the United States that involves sales of Tamiflu for pandemic stockpiling. If resolved in the United States{\textquoteright} favor, he would be entitled to a percentage of the recovery. T.J. is coholder of a Laura and John Arnold Foundation grant for development of a RIAT support center (2017–2020) and Jean Monnet Network Grant, 2017–2020, for The Jean Monnet Health Law and Policy Network. T.J. is an unpaid collaborator to the project Beyond Transparency in Pharmaceutical Research and Regulation led by Dalhousie University and funded by the Canadian Institutes of Health Research (2018 –2022). T.J. consulted for Illumina LLC on next-generation gene sequencing (2019 –2020). T.J. was the consultant scientific coordinator for the HTA Medical Technology program of the Agenzia per i Serivizi Sanitari Nazionali (AGENAS) of the Italian MoH (2007–2019). T.J. is Director Medical Affairs for BC Solutions, a market access company for medical devices in Europe. T.J. is funded by NIHR UK and the World Health Organization (WHO) to update Cochrane review A122, “Physical interventions to interrupt the spread of respiratory viruses.” T.J. is funded by Oxford University to carry out a living review on the transmission epidemiology of COVID-19. Since 2020, T.J. has received fees for articles published by The Spectator and other media outlets. A.R.-F., Haeyoung Lee, and Larissa Shamseer have no competing interests to declare. O{\textquoteright}Mareen Spence has received the Maryland CERSI Scholar award from the Food and Drug Administration (grant 1U01FD005946) and the PhRMA Foundation{\textquoteright}s Predoctoral Fellowship in Health Outcomes. This project was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award (U01FD005946) totaling $5,000 with 100% funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2020",

doi = "10.1128/mSphere.00770-20",

language = "English",

volume = "5",

pages = "1--3",

journal = "mSphere",

issn = "1535-9778",

publisher = "American Society for Microbiology",

number = "6",

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TY - JOUR

T1 - Incompletely Reported Important Methodological Details and Inaccurate Description of the Formulation That the Control Arms Received in a Gardasil Vaccine Trial

AU - Bourgeois, Florence

AU - Doshi, Peter

AU - Hong, Kyungwan

AU - Jefferson, Tom

AU - Jones, Mark

AU - Lee, Haeyoung

AU - Rowhani-Farid, Anisa

AU - Shamseer, Larissa

AU - Spence, O’Mareen M.

N1 - Funding Information: Florence Bourgeois’ work is supported by a grant from the Burroughs Wellcome Fund and by the Harvard-MIT Center for Regulatory Science. The Laura and John Arnold Foundation funds the RIAT Support Center, which supports the salaries of Peter Doshi (P.D.), Kyungwan Hong (K.H.), Mark Jones (M.J.), Tom Jefferson (T.J.), and Anisa Rowhani-Farid (A.R.-F.). In addition, P.D. has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018) and grants from the Laura and John Arnold Foundation (2017–21), American Association of Colleges of Pharmacy (2015), Patient-Centered Outcomes Research Institute (2014 –16), Cochrane Methods Innovations Fund (2016 –18), and UK National Institute for Health Research (2011–14) and is an editor at The BMJ and unpaid member of the Reagan-Udall Foundation for the FDA. K.H. received the Maryland CERSI Scholar award from the Food and Drug Administration (grant 5U01FD005946-04). M.J. reports research funds from the Cochrane Methods Innovation Fund to assist with providing interim guidance on the inclusion of clinical study reports and other regulatory documents in Cochrane Reviews. He is also deputy coordinating editor for the Cochrane Acute Respiratory Infections Group. T.J. was in receipt of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane Reviews (2015–2018). In 2014 to 2016, T.J. was a member of three advisory boards for Boehringer Ingelheim. T.J. is occasionally interviewed by market research companies about phase I or II pharmaceutical products for which he receives fees (current). T.J. was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine (2015–2017). T.J. is a relator in a False Claims Act lawsuit on behalf of the United States that involves sales of Tamiflu for pandemic stockpiling. If resolved in the United States’ favor, he would be entitled to a percentage of the recovery. T.J. is coholder of a Laura and John Arnold Foundation grant for development of a RIAT support center (2017–2020) and Jean Monnet Network Grant, 2017–2020, for The Jean Monnet Health Law and Policy Network. T.J. is an unpaid collaborator to the project Beyond Transparency in Pharmaceutical Research and Regulation led by Dalhousie University and funded by the Canadian Institutes of Health Research (2018 –2022). T.J. consulted for Illumina LLC on next-generation gene sequencing (2019 –2020). T.J. was the consultant scientific coordinator for the HTA Medical Technology program of the Agenzia per i Serivizi Sanitari Nazionali (AGENAS) of the Italian MoH (2007–2019). T.J. is Director Medical Affairs for BC Solutions, a market access company for medical devices in Europe. T.J. is funded by NIHR UK and the World Health Organization (WHO) to update Cochrane review A122, “Physical interventions to interrupt the spread of respiratory viruses.” T.J. is funded by Oxford University to carry out a living review on the transmission epidemiology of COVID-19. Since 2020, T.J. has received fees for articles published by The Spectator and other media outlets. A.R.-F., Haeyoung Lee, and Larissa Shamseer have no competing interests to declare. O’Mareen Spence has received the Maryland CERSI Scholar award from the Food and Drug Administration (grant 1U01FD005946) and the PhRMA Foundation’s Predoctoral Fellowship in Health Outcomes. This project was supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award (U01FD005946) totaling $5,000 with 100% funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2020

Y1 - 2020

UR - http://www.scopus.com/inward/record.url?scp=85095677664&partnerID=8YFLogxK

U2 - 10.1128/mSphere.00770-20

DO - 10.1128/mSphere.00770-20

M3 - Letter

C2 - 33148819

AN - SCOPUS:85095677664

SN - 1535-9778

VL - 5

SP - 1

EP - 3

JO - mSphere

JF - mSphere

IS - 6

ER -

Incompletely Reported Important Methodological Details and Inaccurate Description of the Formulation That the Control Arms Received in a Gardasil Vaccine Trial

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