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  1. Article ; Online: Surrogate Endpoints in Oncology: Overview of Systematic Reviews and Their Use for Health Decision Making in Mexico.

    Ortiz, Yesenia / Fareli, Christian J / Gallegos, Veronica / Hernández, Esteban

    Value in health regional issues

    2021  Volume 26, Page(s) 75–88

    Abstract: Objectives: The use of surrogate endpoints (SEs) for cancer drug approval in health systems is common. The objectives of this study were to identify systematic reviews (SRs) that evaluated the correlation of SEs with overall survival (OS) in cancer ... ...

    Abstract Objectives: The use of surrogate endpoints (SEs) for cancer drug approval in health systems is common. The objectives of this study were to identify systematic reviews (SRs) that evaluated the correlation of SEs with overall survival (OS) in cancer drugs to analyze the applications of approved cancer drugs with SEs in Mexico and to apply the validation framework proposed by the Institute for Quality and Efficiency in Health Care (IQWiG).
    Methods: An overview of SRs was conducted according to Cochrane Collaboration methodology. Applications for approved cancer drugs with SEs in Mexico were analyzed. The IQWiG validation framework was applied to evaluate the SEs identified in the overview and in the applications in Mexico.
    Results: A total of 85 SRs that assessed 192 SEs for different types of cancer were selected. According to the IQWiG model, only 2.5% of the SEs analyzed in the overview and only one of the applications in Mexico could be used as surrogates for OS because the reliability (methodological quality) of the SRs and the strength of the correlation of SEs with OS was mostly low (92%) and low (correlation coefficient r ≤ 0.7; 50.5%), respectively. Of the total number of cancer drugs approved in Mexico, 19.4% used SEs.
    Conclusions: Most SEs for different types of cancer could not be used as surrogates for OS according to the IQWiG model, and their use for the approval of cancer drugs in Mexico is generally not justified.
    MeSH term(s) Biomarkers ; Decision Making ; Humans ; Mexico ; Reproducibility of Results ; Systematic Reviews as Topic
    Chemical Substances Biomarkers
    Language English
    Publishing date 2021-06-12
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2679127-4
    ISSN 2212-1102 ; 2212-1099
    ISSN (online) 2212-1102
    ISSN 2212-1099
    DOI 10.1016/j.vhri.2021.04.002
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials.

    Axfors, Cathrine / Janiaud, Perrine / Schmitt, Andreas M / Van't Hooft, Janneke / Smith, Emily R / Haber, Noah A / Abayomi, Akin / Abduljalil, Manal / Abdulrahman, Abdulkarim / Acosta-Ampudia, Yeny / Aguilar-Guisado, Manuela / Al-Beidh, Farah / Alejandria, Marissa M / Alfonso, Rachelle N / Ali, Mohammad / AlQahtani, Manaf / AlZamrooni, Alaa / Anaya, Juan-Manuel / Ang, Mark Angelo C /
    Aomar, Ismael F / Argumanis, Luis E / Averyanov, Alexander / Baklaushev, Vladimir P / Balionis, Olga / Benfield, Thomas / Berry, Scott / Birocco, Nadia / Bonifacio, Lynn B / Bowen, Asha C / Bown, Abbie / Cabello-Gutierrez, Carlos / Camacho, Bernardo / Camacho-Ortiz, Adrian / Campbell-Lee, Sally / Cao, Damon H / Cardesa, Ana / Carnate, Jose M / Castillo, German Jr J / Cavallo, Rossana / Chowdhury, Fazle R / Chowdhury, Forhad U H / Ciccone, Giovannino / Cingolani, Antonella / Climacosa, Fresthel Monica M / Compernolle, Veerle / Cortez, Carlo Francisco N / Costa Neto, Abel / D'Antico, Sergio / Daly, James / Danielle, Franca / Davis, Joshua S / De Rosa, Francesco Giuseppe / Denholm, Justin T / Denkinger, Claudia M / Desmecht, Daniel / Díaz-Coronado, Juan C / Díaz Ponce-Medrano, Juan A / Donneau, Anne-Françoise / Dumagay, Teresita E / Dunachie, Susanna / Dungog, Cecile C / Erinoso, Olufemi / Escasa, Ivy Mae S / Estcourt, Lise J / Evans, Amy / Evasan, Agnes L M / Fareli, Christian J / Fernandez-Sanchez, Veronica / Galassi, Claudia / Gallo, Juan E / Garcia, Patricia J / Garcia, Patricia L / Garcia, Jesus A / Garigliany, Mutien / Garza-Gonzalez, Elvira / Gauiran, Deonne Thaddeus V / Gaviria García, Paula A / Giron-Gonzalez, Jose-Antonio / Gómez-Almaguer, David / Gordon, Anthony C / Gothot, André / Grass Guaqueta, Jeser Santiago / Green, Cameron / Grimaldi, David / Hammond, Naomi E / Harvala, Heli / Heralde, Francisco M / Herrick, Jesica / Higgins, Alisa M / Hills, Thomas E / Hines, Jennifer / Holm, Karin / Hoque, Ashraful / Hoste, Eric / Ignacio, Jose M / Ivanov, Alexander V / Janssen, Maike / Jennings, Jeffrey H / Jha, Vivekanand / King, Ruby Anne N / Kjeldsen-Kragh, Jens / Klenerman, Paul / Kotecha, Aditya / Krapp, Fiorella / Labanca, Luciana / Laing, Emma / Landin-Olsson, Mona / Laterre, Pierre-François / Lim, Lyn-Li / Lim, Jodor / Ljungquist, Oskar / Llaca-Díaz, Jorge M / López-Robles, Concepción / López-Cárdenas, Salvador / Lopez-Plaza, Ileana / Lucero, Josephine Anne C / Lundgren, Maria / Macías, Juan / Maganito, Sandy C / Malundo, Anna Flor G / Manrique, Rubén D / Manzini, Paola M / Marcos, Miguel / Marquez, Ignacio / Martínez-Marcos, Francisco Javier / Mata, Ana M / McArthur, Colin J / McQuilten, Zoe K / McVerry, Bryan J / Menon, David K / Meyfroidt, Geert / Mirasol, Ma Angelina L / Misset, Benoît / Molton, James S / Mondragon, Alric V / Monsalve, Diana M / Moradi Choghakabodi, Parastoo / Morpeth, Susan C / Mouncey, Paul R / Moutschen, Michel / Müller-Tidow, Carsten / Murphy, Erin / Najdovski, Tome / Nichol, Alistair D / Nielsen, Henrik / Novak, Richard M / O'Sullivan, Matthew V N / Olalla, Julian / Osibogun, Akin / Osikomaiya, Bodunrin / Oyonarte, Salvador / Pardo-Oviedo, Juan M / Patel, Mahesh C / Paterson, David L / Peña-Perez, Carlos A / Perez-Calatayud, Angel A / Pérez-Alba, Eduardo / Perkina, Anastasia / Perry, Naomi / Pouladzadeh, Mandana / Poyato, Inmaculada / Price, David J / Quero, Anne Kristine H / Rahman, Md M / Rahman, Md S / Ramesh, Mayur / Ramírez-Santana, Carolina / Rasmussen, Magnus / Rees, Megan A / Rego, Eduardo / Roberts, Jason A / Roberts, David J / Rodríguez, Yhojan / Rodríguez-Baño, Jesús / Rogers, Benjamin A / Rojas, Manuel / Romero, Alberto / Rowan, Kathryn M / Saccona, Fabio / Safdarian, Mehdi / Santos, Maria Clariza M / Sasadeusz, Joe / Scozzari, Gitana / Shankar-Hari, Manu / Sharma, Gorav / Snelling, Thomas / Soto, Alonso / Tagayuna, Pedrito Y / Tang, Amy / Tatem, Geneva / Teofili, Luciana / Tong, Steven Y C / Turgeon, Alexis F / Veloso, Januario D / Venkatesh, Balasubramanian / Ventura-Enriquez, Yanet / Webb, Steve A / Wiese, Lothar / Wikén, Christian / Wood, Erica M / Yusubalieva, Gaukhar M / Zacharowski, Kai / Zarychanski, Ryan / Khanna, Nina / Moher, David / Goodman, Steven N / Ioannidis, John P A / Hemkens, Lars G

    BMC infectious diseases

    2021  Volume 21, Issue 1, Page(s) 1170

    Abstract: Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the ...

    Abstract Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ).
    Methods: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence.
    Results: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I
    Conclusions: Convalescent plasma treatment of patients with COVID-19 did not reduce all-cause mortality. These results provide strong evidence that convalescent plasma treatment for patients with COVID-19 should not be used outside of randomized trials. Evidence synthesis from collaborations among trial investigators can inform both evidence generation and evidence application in patient care.
    MeSH term(s) COVID-19/therapy ; Humans ; Immunization, Passive ; Randomized Controlled Trials as Topic ; SARS-CoV-2 ; Treatment Outcome ; COVID-19 Serotherapy
    Language English
    Publishing date 2021-11-20
    Publishing country England
    Document type Journal Article ; Meta-Analysis ; Systematic Review
    ZDB-ID 2041550-3
    ISSN 1471-2334 ; 1471-2334
    ISSN (online) 1471-2334
    ISSN 1471-2334
    DOI 10.1186/s12879-021-06829-7
    Database MEDical Literature Analysis and Retrieval System OnLINE

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