File, Thomas M. Jr.
Alexander, Elizabeth
Goldberg, Lisa
Das, Anita F.
Sandrock, Christian
Paukner, Susanne
Moran, Gregory J.
Article History
Received: 1 December 2020
Accepted: 17 March 2021
First Online: 8 May 2021
Declarations
:
: These trials were compliant with the ethical principles of the Declaration of Helsinki, Good Clinical Practice guidelines, and local laws/regulations. All patients provided written informed consent. Before study initiation, participating centers for the LEAP 1 and 2 trials obtained study approval from 130 ethics committees/institutional review boards; 100 are listed here (please see Additional file InternalRef removed: Appendices 1 and 2 for the full list and details): Copernicus Group IRB; Western Institutional Review Board (WIRB); Minneapolis Medical Research Foundation, Human Subjects Research Committee; Appalachian Regional Healthcare Inc., IRB; Louisiana State University Health Sciences Center-Shreveport; Summa Health Institutional Review Board; Human Research Protection Office, Washington University in St. Louis; Veterans Memorial Medical Center Institutional Review Board; Institutional Ethics Review Board (LCP-IERB) Lung Center of the Philippines; University of the Philippines Research Manila Ethics Board (UPMREB); St. Luke’s Institutional Ethics Review Committee; Unified Biomedical Research Ethics Review Committee, West Visayas State University; Institutional Review Board of Bamrasnaradura Infectious Diseases Institute; Comité Institucional de Ética de la Investigación en Salud del Adulto; CIEIS del Niño y del Adulto; Comite Institutional de Etica de Investigacion en Salud (CIEIS); Comité de Ética del Instituto Médico Platense (CEDIMP); Comité de Ética del Sanatorio Británico; Comité de Ética en Investigación Hospital Italiano de La Plata; Comissão Nacional de Ética em Pesquisa—CONEP; Comitȇ de Ética em Pesquisa da Faculdade de Medicina de São José do Rio Preto—FAMERP; Comitȇ de Ética em Pesquisa da Universidade de Passo Fundo; Comitȇ de Ética em Pesquisa—CEP da Pontificia Universidade Católica de Campinas—PUC/Campinas; Comitȇ de Ética em Pesquisa da Santa Casa de Misericórdia de Belo Horizonte; Comité Institucional de Etica en Investigación de la Asociación Benéfica Prisma; Comite Institucional de Etica en Investigacion del Hospital Nacional Arzobispo Loayza; Agency for Medicinal Products and Medical Devices; Ethics Committee of the University Clinical Center Sarajevo; Ethics Committee of the University Clinical Hospital Mostar; Ethics Committee for Multi-Centre Trials; LEC of LTD Diagnostic Services; LTD “Medulla”—Chemotherapy and Immunotherapy Clinic; LTD “Acad. Vakhtang Bochorishvili Center of Sepsis and Infection Pathology”; NCLE”Internal Medicine Clinic of Georgian Patriarchate (for indigents) and its Development Fund”; Local Ethics Committee of LTD Emergency Cardiology Center by Academician G. Chapidze; Local Ethics Committee of LTD National Center for Tuberculosis and Lung diseases”; Egészségügyi Tudományos Tanács Klinikai Farmakológiai Etikai Bizottság; Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet (OGYÉI); The Ethics Committee for Clinical Trials of Medicinal Products; METC Maxima Medisch Centrum; Komisja Bioetyczna przy Okregowej Izbie Lekarskiej w Lodzi; Beskidzka Izba Lekarska; National Bioethics Committee for Medicine and Medical Devices; The Russian Federation Ministry of Healthcare, Department of State Regulation of Circulation of Medicines, Ethics Council; Ethics Expert Council at St. Petersburg State Budget Healthcare Institution “City Hospital No. 40 of Kurortniy Administrative District; Ethics Committee at SBHI of Novosibirsk Region “City Clinical Hospital of Emergency Medicine No. 2”; Independent Ethics Committee at FSBMEI of HPE “Military Medical Academy n.a. S.M. Kirov” MD of RF; Ethics Committee at State Budgetary Health Institution “Regional Clinical Hospital #4”; Ethics Committee at State Budget Institution of Healthcare of Yaroslavl Region “Regional Clinical Hospital”; Ethics Committee at SBEI HPE “Smolensk State Medical University” of the MoH of RF; LEC of Clinical Centre Kragujevac; LEC of Clinical Centre Serbia; LEC of Clinical Centre Nis; LEC of Institute for Pulmonary Diseases of Vojvodina; Pharma-Ethics Independent Research Ethics Committee; Commission on Ethics Questions of Municipal Institution of Health Care Kharkiv City Clinical Hospital # 13; Commission on Ethics Questions of Nation Military and Medical Clinical Centre “Main Military Clinical Hospital”; Commission on Ethics Questions of MI “Chernivtsi Regional Clinical Hospital”; Local Commission on Bioethics Questions of Regional Centre of Phthisiology and Pulmonology; Commission on Ethics Questions of SI “National Institute of Phthisiology & Pulmonology n.a. F. G.Yanovskyi of NAMS of Ukraine”; Commission on Ethics Questions of Municipal Institution Central City Hospital #1 City of Zhytomyr; Commission on Ethics Questions of Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital; Commission on Ethics Questions of Municipal Institution “Kherson City Clinical Hospital n.a. A. and O. Tropinykh”; Commission on Ethics Questions of Municipal Institution “City Hospital #7”; Commission on Ethics Questions of Municipal Institution Odesa Regional Clinical Hospital; Commission on Ethics Questions of Municipal Institute 6th City Clinical Hospital; Olive View-UCLA Education & Research Institute; University of Virginia Institutional Review Board for Health Sciences Research (UVA IRB-HSR); Chesapeake IRB; Community Medical Centers Institutional Review Board; St. Rita’s Health Partners (SRHP); UC Davis IRB; Biomedical Research Alliance of New York IRB; Comité de Ética en Investigación del Hospital Universitario “Dr. José Eleuterio González”; Comité de Ética en Investigación de Accelerium S. de R.L. de C.V.; Comité de Ética en Investigación de Promotora Médica Aquascalientes, S.A. de C.V.; Comité de Ética en Investigación del Hospital Civil Fray Antonio Alcalde; Manila Central University Filemon D. Tanchoco Sr. Medical Foundation Institutional Review Board (MCU-FDT IRB); Hospital Ethics Committee Quirino Memorial Medical Center; Chong Hua Hospital Institutional Review Board; Institutional Review Board of The Catholic University of Korea, St. Paul’s Hospital; Institutional Review Board of Ewha Womans University Mokdong Hospital; Institutional Review Board of Yeungnam University Hospital; Institutional Review Board of The Catholic University of Korea, Uijeongbu St. Mary’s Hospital; Institutional Review Board of Konkuk University Medical Center; Institutional Review Board of Korea University Guro Hospital; Institutional Review Board of The Catholic University of Korea, Bucheon St. Mary’s Hospital; Kaohsiung Medical University Chung-Ho Memorial Hospital Institutional Review Board; Institutional Review Board of the E-DA Hospital; China Medical University & Hospital Research Ethics Committee; National Taiwan University Hospital Research Ethics Committee; Research Ethics Review Committee, Far Eastern Memorial Hospital; Comité de Ética en Investigación de CEMIC; Comité de Etica San Isidro—Instituto Medico de Alta Complejidad San Isidro; Comité Independiente de Ética para Ensayos en Farmacología Clínica CIEFC; Comité de Ética em Pesquisa em Seres Humanos da Fundacão Universidade de Passo Fundo—VRPPG; Comité Institucional de Ética en la Investigación del Hospital Nacional Cayetano Heredia; Comité de Ética Hospital Carlos Alberto Seguín Escobedo—EsSalud; Comité de Ética en Investigación Biomédica del Hospital Nacional Dos de Mayo; Comité de Ética Científica Servicio de Salud Araucanía Sur.
: Not applicable.
: TMF has served as a consultant for bioMérieux, Curetis, Merck, Motif BioSciences, Nabriva Therapeutics, Paratek, Pfizer, and Shionogi Inc. and received grants from Nabriva Therapeutics. SP is an employee of/stockholder in Nabriva Therapeutics plc. EA and LG were employees of/stockholders in Nabriva Therapeutics plc at the time of the analysis. AFD has served as a consultant for Achaogen, AntibioTx, Boston Pharmaceuticals, Cempra, ContraFect, IterumTx, Nabriva Therapeutics, Paratek, Tetraphase, Theravance, UTILITY, Wockhardt, and Zavante. CS has served as a consultant for Allergan and Nabriva Therapeutics, received grants from the National Institutes of Health and the Health Resources & Services Administration, and received nonfinancial support from the State of California. GJM has received grants from ContraFect and Nabriva Therapeutics.