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Research Articles

Leveraging Real-World Data in COVID-19 Response

, ORCID Icon, ORCID Icon, , &
Pages 582-595 | Received 22 Oct 2021, Accepted 27 Jun 2022, Published online: 14 Sep 2022

References

  • Abolghasemi, H., Eshghi, P., Cheraghali, A. M., Imani Fooladi, A. A., Bolouki Moghaddam, F., Imanizadeh, S., Moeini Maleki, M., Ranjkesh, M., Rezapour, M., Bahramifar, A., Einollahi, B., Hosseini, M. J., Jafari, N. J., Nikpouraghdam, M., Sadri, N., Tazik, M., Sali, S., Okati, S., Askari, E., Tabarsi, P., Aslani, J., Sharifipour, E., Jarahzadeh, M. H., Khodakarim, N., Salesi, M., Jafari, R., and Shahverdi, S. (2020), “Clinical Efficacy of Convalescent Plasma for Treatment of COVID-19 Infections: Results of a Multicenter Clinical Study,” Transfusion and Apheresis Science, 59, 102875. DOI: 10.1016/j.transci.2020.102875.
  • AHA COVID-19 CVD Registry (2021), available at https://www.heart.org/en/professional/quality-improvement/covid-19-cvd-registry. Accessed October 21, 2021.
  • Anderson, R. M., Heesterbeek, H., Klinkenberg, D., and Hollingsworth, T. D. (2020), “How will Country-based Mitigation Measures Influence the Course of the COVID-19 Epidemic?” The Lancet, 395, 931–934. DOI: 10.1016/S0140-6736(20)30567-5.
  • Arshad, S., Kilgore, P., Chaudhry, Z. S., Jacobsen, G., Wang, D. D., Huitsing, K., Brar, I., Alangaden, G. J., Ramesh, M. S., McKinnon, J. E., O’Neill, W., Zervos, M., Nauriyal, V., Hamed, A. A., Nadeem, O., Swiderek, J., Godfrey, A., Jennings, J., Gardner-Gray, J., Ackerman, A. M., Lezotte, J., Ruhala, J., Fadel, R., Vahia, A., Gudipati, S., Parraga, T., Shallal, A., Maki, G., Tariq, Z., Suleyman, G., Yared, N., Herc, E., Williams, J., Lanfranco, O. A., Bhargava, P., and Reyes, K. (2020), “Treatment with Hydroxychloroquine, Azithromycin, and Combination in Patients Hospitalized with COVID-19,” International Journal of Infectious Diseases, 97, 396–403. DOI: 10.1016/j.ijid.2020.06.099.
  • ASCO Survey on COVID-19 in Oncology (ASCO) Registry (2021), available at https://www.asco.org/asco-coronavirus-information/coronavirus-registry. Accessed October 21, 2021.
  • Balmford, B., Annan, J. D., Hargreaves, J. C., Altoè, M., and Bateman, I. J. (2020), “Cross-Country Comparisons of Covid-19: Policy, Politics and the Price of Life,” Environmental & Resource Economics, 76, 525–551.
  • Biran, N., Ip, A., Ahn, J., Go, R. C., Wang, S., Mathura, S., Sinclaire, B. A., Bednarz, U., Marafelias, M., Hansen, E., Siegel, D. S., Goy, A. H., Pecora, A. L., Sawczuk, I. S., Koniaris, L. S., Simwenyi, M., Varga, D. W., Tank, L. K., Stein, A. A., Allusson, V., Lin, G. S., Oser, W. F., Tuma, R. A., Reichman, J., Brusco, L., Carpenter, K. L., Costanzo, E. J., Vivona, V., and Goldberg, S. L. (2020), “Tocilizumab among Patients with COVID-19 in the Intensive Care Unit: A Multicentre Observational Study,” The Lancet. Rheumatology, 2, e603–e612. DOI: 10.1016/S2665-9913(20)30277-0.
  • Blonde, L., Khunti, K., Harris, S. B., Meizinger, C., and Skolnik, N. S. (2018), “Interpretation and Impact of Real-World Clinical Data for the Practicing Clinician,” Advances in Therapy, 35, 1763–1774. DOI: 10.1007/s12325-018-0805-y.
  • Bol, D., Giani, M., Blais, A., and Loewen, P. J. (2020), “The Effect of COVID-19 Lockdowns on Political Support: Some Good News for Democracy?,” European Journal of Political Research, 60, 497–505. DOI: 10.1111/1475-6765.12401.
  • Boulware, D. R., Pullen, M. F., Bangdiwala, A. S., Pastick, K. A., Lofgren, S. M., Okafor, E. C., Skipper, C. P., Nascene, A. A., Nicol, M. R., Abassi, M., Engen, N. W., Cheng, M. P., LaBar, D., Lother, S. A., MacKenzie, L. J., Drobot, G., Marten, N., Zarychanski, R., Kelly, L. E., Schwartz, I. S., McDonald, E. G., Rajasingham, R., Lee, T. C., and Hullsiek, K. H. (2020), “A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19,” The New England Journal of Medicine, 383, 517–525. DOI: 10.1056/NEJMoa2016638.
  • Carnegie Mellon University COVIDcast (2021), available at https://delphi.cmu.edu/covidcast/. Accessed October 21, 2021.
  • Carnegie Mellon University Delphi Epidata API (2021), available at https://cmu-delphi.github.io/delphi-epidata/api/covidcast/textunderscoresignals.html. Accessed October 21, 2021.
  • Carnegie Mellon University DELPHI (2021), available at https://delphi.cmu.edu/. Accessed October 21, 2021.
  • Cavalcanti, A. B., Zampieri, F. G., Rosa, R. G., Azevedo, L. C. P., Veiga, V. C., Avezum, A., Damiani, L. P., Marcadenti, A., Kawano-Dourado, L., Lisboa, T., Junqueira, D. L. M., de Barros E Silva, P. G. M., Tramujas, L., Abreu-Silva, E. O., Laranjeira, L. N., Soares, A. T., Echenique, L. S., Pereira, A. J., Freitas, F. G. R., Gebara, O. C. E., Dantas, V. C. S., Furtado, R. H. M., Milan, E. P., Golin, N. A., Cardoso, F. F., Maia, I. S., Hoffmann Filho, C. R., Kormann, A. P. M., Amazonas, R. B., Bocchi de Oliveira, M. F., Serpa-Neto, A., Falavigna, M., Lopes, R. D., Machado, F. R., Berwanger, O., and Coalition Covid-19 Brazil I Investigators. (2020), “Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19,” The New England Journal of Medicine, 383, 2041–2052. Erratum in: The New England Journal of Medicine, 2020 Nov 19;383(21):e119.
  • CDC COVID-NET. (2021), Available at: https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html. Accessed October 21, 2021.
  • Centers for Disease Control and Prevention (2021), “COVID-19 Mathematical Modeling,” available at https://www.cdc.gov/coronavirus/2019-ncov/covid-data/mathematical-modeling.html. Accessed October 2021.
  • Chaudhuri, S., Lo, A. W., Xiao, D., and Xu, Q. (2020), “Bayesian Adaptive Clinical Trials for Anti-Infective Therapeutics during Epidemic Outbreaks,” Harvard Data Science Review, Special Issue 1. DOI: 10.1162/99608f92.7656c213..
  • Chen, M., Fan, Y., Wu, X., Zhang, L., Guo, T., Deng, K., Gao, J., Luo, H., He, T., Gong, Y., Wang, H., Wan, J., Wang, X., and Lu, Z. (2020), “Clinical Characteristics And Risk Factors For Fatal Outcome in Patients With 2019-Coronavirus Infected Disease (COVID-19) in Wuhan, China,” Lancet. DOI: 10.2139/ssrn.3546069..
  • Chen, J., Ho, M., Lee, K., Song, Y., Fang, Y., Goldstein, B. A., He, W., Irony, T., Jiang, Q., van der Laan, M., Lee, H., Lin, X., Meng, Z., Mishra-Kalyani, P., Rockhold, F., Wang, H., and White, R. (2021), “The Current Landscape in Biostatistics of Real-World Data and Evidence: Clinical Study Design and Analysis,” Statistics in Biopharmaceutical Research, 1–4. DOI: 10.1080/19466315.2021.1883474.
  • ClinicalTrials.gov Adaptive COVID-19 Treatment Trial 4 (ACTT-4) (2021), available at https://clinicaltrials.gov/ct2/show/NCT04640168. Accessed October 21, 2021.
  • Collins, R., Bowman, L., Landray, M., and Peto, R. (2020), “The Magic of Randomization versus the Myth of Real-World Evidence,” The New England Journal of Medicine, 382, 674–678. DOI: 10.1056/NEJMsb1901642.
  • Cook, J. A., Julious, S. A., Sones, W., Rothwell, J. C., Ramsay, C. R., Hampson, L. V., Emsley, R., Walters, S. J., Hewitt, C., Bland, M., Fergusson, D. A., Berlin, J. A., Altman, D., and Vale, L. D. (2017), “Choosing the Target Difference (‘effect size’) for a Randomised Controlled Trial – DELTA2 Guidance Protocol,” Trials, 18, 271. DOI: 10.1186/s13063-017-1969-5.
  • COVID-19 Evidence Accelerator (2021), available at https://friendsofcancerresearch.org/covid19. Accessed October 21, 2021.
  • COVID-19 Forecast Hub (2021), available at https://covid19forecasthub.org/. Accessed October 21, 2021.
  • COVID-19 Predictions (2021), available at https://yumouqiu.shinyapps.io/covid-predict/. Accessed October 21, 2021.
  • COVID-19 RISK and Treatments (CORIST) Collaboration (2020), “Use of Hydroxychloroquine in Hospitalised COVID-19 Patients is Associated with Reduced Mortality: Findings from the Observational Multicentre Italian CORIST Study,” European Journal of Internal Medicine, 82, 38–47.
  • Dickerman, B. A., García-Albéniz, X., Logan, R. W., Denaxas, S., and Hernán, M. A. (2019), “Avoidable Flaws in Observational Analyses: An Application to Statins and Cancer,” Nature Medicine, 25, 1601–1606. DOI: 10.1038/s41591-019-0597-x.
  • Discovery VIRUS COVID-19 Registry (2021), available at https://www.sccm.org/Research/Research/Discovery-Research-Network/VIRUS-COVID-19-Registry. Accessed October 21, 2021.
  • Dodd, L. E., Follmann, D., Wang, J., Koenig, F., Korn, L. L., Schoergenhofer, C., Proschan, M., Hunsberger, S., Bonnett, T., Makowski, M., Belhadi, D., Wang, Y., Cao, B., Mentre, F., and Jaki, T. (2020), “Endpoints for Randomized Controlled Clinical Trials for COVID-19 Treatments,” Clinical Trials (London, England), 17, 472–482. DOI: 10.1177/1740774520939938.
  • Duan, K., Liu, B., Li, C., Zhang, H., Yu, T., Qu, J., Zhou, M., Chen, L., Meng, S., Hu, Y., Peng, C., Yuan, M., Huang, J., Wang, Z., Yu, J., Gao, X., Wang, D., Yu, X., Li, L., Zhang, J., Wu, X., Li, B., Xu, Y., Chen, W., Peng, Y., Hu, Y., Lin, L., Liu, X., Huang, S., Zhou, Z., Zhang, L., Wang, Y., Zhang, Z., Deng, K., Xia, Z., Gong, Q., Zhang, W., Zheng, X., Liu, Y., Yang, H., Zhou, D., Yu, D., Hou, J., Shi, Z., Chen, S., Chen, Z., Zhang, X., and Yang, X. (2020), “Effectiveness of Convalescent Plasma Therapy in Severe COVID-19 Patients,” Proceedings of the National Academy of Sciences of the United States of America, 117, 9490–9496. DOI: 10.1073/pnas.2004168117.
  • Eichler, H.-G., Koenig, F., Arlett, P., Enzmann, H., Humphreys, A., Pétavy, F., Schwarzer-Daum, B., Sepodes, B., Vamvakas, S., and Rasi, G. (2020), “Are Novel, Nonrandomized Analytic Methods Fit for Decision Making? The Need for Prospective, Controlled, and Transparent Validation,” Clinical Pharmacology and Therapeutics, 107, 773–779. DOI: 10.1002/cpt.1638.
  • Ezzat, V. A., Lee, V., Ahsan, S., Chow, A. W., Segal, O., Rowland, E., Lowe, M. D., and Lambiase, P. D. (2015), “A Systematic Review of ICD Complications in Randomised Controlled Trials Versus Registries: Is Our ‘Real-WORLD’DATA an Underestimation?,” Open Heart, 2, e000198. DOI: 10.1136/openhrt-2014-000198.
  • FDA News & Events for Human Drugs (2020), “Real World Evidence – From Safety to a Potential Tool for Advancing Innovative Ways to Develop New Medical Therapies,” available at https://www.fda.gov/drugs/news-events-human-drugs/real-world-evidence-safety-potential-tool-advancing-innovative-ways-develop-new-medical-therapies. Content current as of: 24 Feb 2020.
  • Firth, J. A., Hellewell, J., Klepac, P., Kissler, S., Kucharski, A. J., Spurgin, L. G., and CMMID COVID-19 Working Group. (2020), “Using a Real-World Network to Model Localized COVID-19 Control Strategies,” Nature Medicine, 26, 1616–1622. DOI: 10.1038/s41591-020-1036-8.
  • Franchetti, Y. (2022), “Use of Propensity Scoring and Its Application to Real-World Data: Advantages, Disadvantages, and Methodological Objectives Explained to Researchers Without Using Mathematical Equations,” Journal of Clinical Pharmacology, 62, 304–319. DOI: 10.1002/jcph.1989.
  • Gao, J., Tian, Z., and Yang, X. (2020), “Breakthrough: Chloroquine Phosphate has shown Apparent Efficacy in Treatment of COVID-19 Associated Pneumonia in Clinical Studies,” Bioscience Trends, 14, 72–73. DOI: 10.5582/bst.2020.01047.
  • Gautret, P., Lagier, J.-C., Parola, P., Hoang, V. T., Meddeb, L., Mailhe, M., Doudier, B., Courjon, J., Giordanengo, V., Vieira, V. E., Tissot Dupont, H., Honoré, S., Colson, P., Chabrière, E., La Scola, B., Rolain, J.-M., Brouqui, P., and Raoult, D. (2020), “Hydroxychloroquine and Azithromycin as a Treatment of COVID-19: Results of an Open-Label Non-randomized Clinical Trial,” International Journal of Antimicrobial Agents., 56, 105949. DOI: 10.1016/j.ijantimicag.2020.105949.
  • Geleris, J., Sun, Y., Platt, J., Zucker, J., Baldwin, M., Hripcsak, G., Labella, A., Manson, D. K., Kubin, C., Barr, R. G., Sobieszczyk, M. E., and Schluger, N. W. (2020), “Observational Study of Hydroxychloroquine in Hospitalized Patients with Covid-19,” The New England Journal of Medicine, 382, 2411–2418. DOI: 10.1056/NEJMoa2012410.
  • Ghadessi, M., Tang, R., Zhou, J., Liu, R., Wang, C., Toyoizumi, K., Mei, C., Zhang, L., Deng, C. Q., and Beckman, R. A. (2020), “A Roadmap to using Historical Controls in Clinical Trials–by Drug Information Association Adaptive Design Scientific Working Group (DIA-ADSWG),” Orphanet Journal of Rare Diseases, 15, 1–9. DOI: 10.1186/s13023-020-1332-x.
  • Gökbuget, N., Kelsh, M., Chia, V., Advani, A., Bassan, R., Dombret, H., Doubek, M., Fielding, A. K., Giebel, S., Haddad, V., Hoelzer, D., Holland, C., Ifrah, N., Katz, A., Maniar, T., Martinelli, G., Morgades, M., O’Brien, S., Ribera, J.-M., Rowe, J. M., Stein, A., Topp, M., Wadleigh, M., and Kantarjian, H. (2016), “Blinatumomab vs Historical Standard Therapy of Adult Relapsed/Refractory Acute Lymphoblastic Leukemia,” Blood Cancer Journal, 6, e473. DOI: 10.1038/bcj.2016.84.
  • Goldberg, M. H., Gustafson, A., Maibach, E. W., Ballew, M. T., Bergquist, P., Kotcher, J. E., Marlon, J. R., Rosenthal, S. A., and Leiserowitz, A. (2020), “Mask-Wearing Increased after a Government Recommendation: A Natural Experiment in the US during the COVID-19 Pandemic,” Frontiers in Communication, 5, 44. DOI: 10.3389/fcomm.2020.00044.
  • Government of India (2021), “State/UT wise Aadhaar Saturation: 15th January 2020,” available at https://uidai.gov.in/images/state-wise-aadhaar-saturation.pdf. Accessed October 21, 2021.
  • Goyal, P., Choi, J. J., Pinheiro, L. C., Schenck, E. J., Chen, R., Jabri, A., Satlin, M. J., Campion, T. R., Nahid, M., Ringel, J. B., Hoffman, K. L., Alshak, M. N., Li, H. A., Wehmeyer, G. T., Rajan, M., Reshetnyak, E., Hupert, N., Horn, E. M., Martinez, F. J., Gulick, R. M., and Safford, M. M. (2020), “Clinical Characteristics of Covid-19 in New York City,” The New England Journal of Medicine, 382, 2372–2374. DOI: 10.1056/NEJMc2010419.
  • Gu, J., Yan, H., Huang, Y., Zhu, Y., Sun, H., Zhang, X., Wang, Y., Qiu, Y., and Chen, X. (2020), “Better Strategies for Containing COVID-19 Epidemics – A Study of 25 Countries via an Extended Varying Coefficient SEIR Model,” MedRxiv. DOI: 10.1101/2020.04.27.20081232..
  • Hainmueller, J., and Xu, Y. (2013), “A Stata Package for Entropy Balancing,” Journal of Statistical Software, 54, 1–18. DOI: 10.18637/jss.v054.i07.
  • Hale, T., Angrist, N., Boby, T., Cameron-Blake, E., Hallas, L., and Kira, B. (2020), “Variation in Government Responses to COVID-19” Version 10.0. Blavatnik School of Government Working Paper. available at https://www.bsg.ox.ac.uk/sites/default/files/2020-12/BSG-WP-2020-032-v10.pdf. Accessed 21 OCT 2021.
  • Hao, X., Cheng, S., Wu, D., Wu, T., Lin, X., and Wang, C. (2020), “Reconstruction of the Full Transmission Dynamics of COVID-19 in Wuhan,” Nature, 584, 420–424. DOI: 10.1038/s41586-020-2554-8.
  • He, X., Lau, E. H. Y., Wu, P., Deng, X., Wang, J., Hao, X., Lau, Y. C., Wong, J. Y., Guan, Y., Tan, X., Mo, X., Chen, Y., Liao, B., Chen, W., Hu, F., Zhang, Q., Zhong, M., Wu, Y., Zhao, L., Zhang, F., Cowling, B. J., Li, F., and Leung, G. M. (2020), “Temporal Dynamics in Viral Shedding and Transmissibility of COVID-19,” Nature Medicine, 26, 672–675. DOI: 10.1038/s41591-020-0869-5.
  • Ho, M., van der Laan, M., Lee, H., Chen, J., Lee, K., Fang, Y., He, W., Irony, T., Jiang, Q., Lin, X., Meng, Z. (2021), “The Current Landscape in Biostatistics of Real-World Data and Evidence: Causal Inference Frameworks for Study Design and Analysis,” Statistics in Biopharmaceutical Research, 12, 1–4. DOI: 10.1080/19466315.2021.1883475.
  • International Institute for Population Sciences (2021), “National Family Health Survey,” available at http://rchiips.org/NFHS/nfhs4.shtml. Accessed October 21, 2021.
  • ISU and PKU Model: Collaborative team of Iowa State and Peking University – ISUandPKU-vSEIdR (2021), available at https://zoltardata.com/model/268. Accessed October 21, 2021.
  • JHU Johns Hopkins Coronavirus Resource Center (2021), available at https://coronavirus.jhu.edu/. Accessed October 21, 2021.
  • John, M., and Shaiba, H. (2019), “Main Factors Influencing Recovery in MERS Co-V Patients using Machine Learning,” Journal of Infection and Public Health, 12, 700–704. DOI: 10.1016/j.jiph.2019.03.020.
  • Joyner, M. J., Klassen, S. A., Senefeld, J., Johnson, P. W., Carter, R. E., and Wiggins, C. C. (2020a), “Evidence Favouring the Efficacy of Convalescent Plasma for COVID-19 Therapy,” medRxiv, 20162917.
  • Joyner, M. J., Senefeld, J. W., Klassen, S. A., Mills, J. R., Johnson, P. W., and Theel, E. S. (2020b), “Effect of Convalescent Plasma on Mortality among Hospitalized Patients with COVID-19: Initial Three-Month Experience,” medRxiv, 20169359.
  • Joyner, M. J., Wright, R. S., Fairweather, D., Senefeld, J. W., Bruno, K. A., Klassen, S. A., Carter, R. E., Klompas, A. M., Wiggins, C. C., Shepherd, J. R. A., Rea, R. F., Whelan, E. R., Clayburn, A. J., Spiegel, M. R., Johnson, P. W., Lesser, E. R., Baker, S. E., Larson, K. F., Ripoll, J. G., Andersen, K. J., Hodge, D. O., Kunze, K. L., Buras, M. R., Vogt, M. N. P., Herasevich, V., Dennis, J. J., Regimbal, R. J., Bauer, P. R., Blair, J. E., Van Buskirk, C. M., Winters, J. L., Stubbs, J. R., Paneth, N. S., Verdun, N. C., Marks, P., and Casadevall, A. (2020c), “Early Safety Indicators of COVID-19 Convalescent Plasma in 5000 Patients,” Journal of Clinical Investigation, 130, 4791–4797. DOI: 10.1172/JCI140200.
  • Joyner, M. J., Carter, R. E., Senefeld, J. W., Klassen, S. A., Mills, J. R., Johnson, P. W., Theel, E. S., Wiggins, C. C., Bruno, K. A., Klompas, A. M., Lesser, E. R., Kunze, K. L., Sexton, M. A., Diaz Soto, J. C., Baker, S. E., Shepherd, J. R. A., van Helmond, N., Verdun, N. C., Marks, P., van Buskirk, C. M., Winters, J. L., Stubbs, J. R., Rea, R. F., Hodge, D. O., Herasevich, V., Whelan, E. R., Clayburn, A. J., Larson, K. F., Ripoll, J. G., Andersen, K. J., Buras, M. R., Vogt, M. N. P., Dennis, J. J., Regimbal, R. J., Bauer, P. R., Blair, J. E., Paneth, N. S., Fairweather, D., Wright, R. S., and Casadevall, A. (2021), “Convalescent Plasma Antibody Levels and the Risk of Death from Covid-19,” The New England Journal of Medicine, 384, 1015–1027. DOI: 10.1056/NEJMoa2031893.
  • Kenji, M., Katsushi, K., Alexander, Z., and Gerardo, C. (2020), “Estimating the Asymptomatic Proportion of Coronavirus Disease 2019 (COVID-19) Cases on Board the Diamond Princess Cruise Ship, Yokohama, Japan, 2020,” Eurosurveillance, 25, pii =2000180.
  • Kraemer, M. U. G., Yang, C.-H., Gutierrez, B., Wu, C.-H., Klein, B., Pigott, D. M., Du Plessis, L., Faria, N. R., Li, R., Hanage, W. P., Brownstein, J. S., Layan, M., Vespignani, A., Tian, H., Dye, C., Pybus, O. G., Scarpino, S. V., and Open COVID-19 Data Working Group. (2020), “The Effect of Human Mobility and Control Measures on the COVID-19 Epidemic in China,” Science, 368, 493–497. DOI: 10.1126/science.abb4218.
  • Levenson, M., He, W., Chen, J., Fang, Y., Faries, D., Goldstein, B. A., Ho, M., Lee, K., Mishra-Kalyani, P., Rockhold, F., Wang, H., and Zink, R. C. (2021), “Biostatistical Considerations When using RWD and RWE in Clinical Studies for Regulatory Purposes: A Landscape Assessment,” Statistics in Biopharmaceutical Research, 9, 1–1. DOI: 10.1080/19466315.2021.1883473.
  • Lin, J., Gamalo-Siebers, M., and Tiwari, R. (2018), “Propensity Score Matched Augmented Controls in Randomized Clinical Trials: A Case Study,” Pharmaceutical Statistics, 17, 629–647. DOI: 10.1002/pst.1879.
  • Lin, J., Gamalo-Siebers, M., and Tiwari, R. (2019), “Propensity-Score-Based Priors for Bayesian Augmented Control Design,” Pharmaceutical Statistics, 18, 223–238. DOI: 10.1002/pst.1918.
  • Lippi, G., Plebani, M., and Henry, B. M. (2020), “Thrombocytopenia is Associated with Severe Coronavirus Disease 2019 (COVID-19) Infections: A Meta-Analysis,” Clinica Chimica Acta, 506, 145–148. DOI: 10.1016/j.cca.2020.03.022.
  • Liu, S., Luo, H., Wang, Y., Wang, D., Ju, S., and Yang, Y. (2020), “Characteristics and Associations with Severity in COVID-19 Patients: A Multicentre Cohort Study from Jiangsu Province, China,” SSRN. DOI: 10.2139/ssrn.3548753.
  • Madigan, D., Ryan, P. B., Schuemie, M., Stang, P. E., Overhage, J. M., Hartzema, A. G., Suchard, M. A., DuMouchel, W., and Berlin, J. A. (2013), “Evaluating the Impact of Database Heterogeneity on Observational Study Results,” American Journal of Epidemiology, 178, 645–651. DOI: 10.1093/aje/kwt010.
  • Martina, R., Jenkins, D., Bujkiewicz, S., Dequen, P., and Abrams, K., on Behalf of Get Real Workpage (2018), “The Inclusion of Real World Evidence in Clinical Development Planning,” Trials, 19, 468. DOI: 10.1186/s13063-018-2769-2.
  • Menni, C., Valdes, A. M., Freidin, M. B., Sudre, C. H., Nguyen, L. H., Drew, D. A., Ganesh, S., Varsavsky, T., Cardoso, M. J., El-Sayed Moustafa, J. S., Visconti, A., Hysi, P., Bowyer, R. C. E., Mangino, M., Falchi, M., Wolf, J., Ourselin, S., Chan, A. T., Steves, C. J., and Spector, T. D. (2020a), “Real-Time Tracking of Self-Reported Symptoms to Predict Potential COVID-19,” Nature Medicine, 26, 1037–1034. DOI: 10.1038/s41591-020-0916-2.
  • Menni, C., Valdes, A., Freydin, M. B., Ganesh, S., Moustafa, J. E.-S., Visconti, A., Hysi, P., Bowyer, R. C. E., Mangino, M., Falchi, M., Wolf, J., Steves, C. J., and Spector, T. D. (2020b), “Loss of Smell and Taste in Combination with other Symptoms is a Strong Predictor of COVID-19 Infection,” Nature Medicine, 26, 1037–1040.
  • National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Drug Discovery, Development, and Translation, Shore, C., and Gee, A. W. eds. (2019), Examining the Impact of Real-World Evidence on Medical Product Development: Proceedings of a Workshop Series. Washington (DC): National Academies Press (US). February 6, 2019, Barriers and Disincentives to the Use of Real-World Evidence and Real-World Data. available at https://www.ncbi.nlm.nih.gov/books/NBK540112/. Accessed October 21, 2021.
  • NIH-COVID-19 Treatment Guidelines (2020), “Chloroquine or Hydroxychloroquine With or Without Azithromycin,” October 9, 2020. available at https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/chloroquine-or-hydroxychloroquine-with-or-without-azithromycin/. Accessed October 21, 2021.
  • Ooi, S. T., Parthasarathy, P., Lin, Y., Nallakaruppan, V., Ng, S., and Tan, T. C. (2020), “Adjunctive Corticosteroids for COVID-19: A Retrospective Cohort Study,” MedRxiv. DOI: 10.1101/2020.07.18.20157008..Accessed October 21, 2021.
  • Oxford COVID-19 Government Response Tracker (2021), “Blavatnik School of Government.” Available at: https://www.bsg.ox.ac.uk/research/research-projects/covid-19-government-response-tracker. Accessed October 21, 2021.
  • PIDTRAN Pediatric COVID-19 Case Registry (2021), available at https://www.pedscovid19registry.com/. Accessed October 21, 2021.
  • Rosenberg, E. S., Dufort, E. M., Udo, T., Wilberschied, L. A., Kumar, J., Tesoriero, J., Weinberg, P., Kirkwood, J., Muse, A., DeHovitz, J., Blog, D. S., Hutton, B., Holtgrave, D. R., and Zucker, H. A. (2020), “Association of Treatment With Hydroxychloroquine or Azithromycin With In-Hospital Mortality in Patients With COVID-19 in New York State,” JAMA, 323, 2493–2502. DOI: 10.1001/jama.2020.8630.
  • Rudrapatna, V. A., and Butte, A. J. (2020), “Opportunities and Challenges in Using Real-World Data for Health Care,” The Journal of Clinical Investigation, 130, 565–574. DOI: 10.1172/JCI129197.
  • Seifu, Y., Gamalo-Siebers, M., Barthel, F. M.-S., Lin, J., Qiu, J., Cooner, F., Ruan, S., and Walley, R. (2020), “Real-World Evidence Utilization in Clinical Development Reflected by US Product Labeling: Statistical Review,” Therapeutic Innovation & Regulatory Science, 54, 1436–1443.
  • Self, W. H., Semler, M. W., Leither, L. M., Casey, J. D., Angus, D. C., Brower, R. G., Chang, S. Y., Collins, S. P., Eppensteiner, J. C., Filbin, M. R., Files, D. C., Gibbs, K. W., Ginde, A. A., Gong, M. N., Harrell, F. E., Hayden, D. L., Hough, C. L., Johnson, N. J., Khan, A., Lindsell, C. J., Matthay, M. A., Moss, M., Park, P. K., Rice, T. W., Robinson, B. R. H., Schoenfeld, D. A., Shapiro, N. I., Steingrub, J. S., Ulysse, C. A., Weissman, A., Yealy, D. M., Thompson, B. T., Brown, S. M., Steingrub, J., Smithline, H., Tiru, B., Tidswell, M., Kozikowski, L., Thornton-Thompson, S., De Souza, L., Hou, P., Baron, R., Massaro, A., Aisiku, I., Fredenburgh, L., Seethala, R., Johnsky, L., Riker, R., Seder, D., May, T., Baumann, M., Eldridge, A., Lord, C., Shapiro, N., Talmor, D., O’Mara, T., Kirk, C., Harrison, K., Kurt, L., Schermerhorn, M., Banner-Goodspeed, V., Boyle, K., Dubosh, N., Filbin, M., Hibbert, K., Parry, B., Lavin-Parsons, K., Pulido, N., Lilley, B., Lodenstein, C., Margolin, J., Brait, K., Jones, A., Galbraith, J., Peacock, R., Nandi, U., Wachs, T., Matthay, M., Liu, K., Kangelaris, K., Wang, R., Calfee, C., Yee, K., Hendey, G., Chang, S., Lim, G., Qadir, N., Tam, A., Beutler, R., Levitt, J., Wilson, J., Rogers, A., Vojnik, R., Roque, J., Albertson, T., Chenoweth, J., Adams, J., Pearson, S., Juarez, M., Almasri, E., Fayed, M., Hughes, A., Hillard, S., Huebinger, R., Wang, H., Vidales, E., Patel, B., Ginde, A., Moss, M., Baduashvili, A., McKeehan, J., Finck, L., Higgins, C., Howell, M., Douglas, I., Haukoos, J., Hiller, T., Lyle, C., Cupelo, A., Caruso, E., Camacho, C., Gravitz, S., Finigan, J., Griesmer, C., Park, P., Hyzy, R., Nelson, K., McDonough, K., Olbrich, N., Williams, M., Kapoor, R., Nash, J., Willig, M., Ford, H., Gardner-Gray, J., Ramesh, M., Moses, M., Ng Gong, M., Aboodi, M., Asghar, A., Amosu, O., Torres, M., Kaur, S., Chen, J.-T., Hope, A., Lopez, B., Rosales, K., Young You, J., Mosier, J., Hypes, C., Natt, B., Borg, B., Salvagio Campbell, E., Hite, R. D., Hudock, K., Cresie, A., Alhasan, F., Gomez-Arroyo, J., Duggal, A., Mehkri, O., Hastings, A., Sahoo, D., Abi Fadel, F., Gole, S., Shaner, V., Wimer, A., Meli, Y., King, A., Terndrup, T., Exline, M., Pannu, S., Robart, E., Karow, S., Hough, C., Robinson, B., Johnson, N., Henning, D., Campo, M., Gundel, S., Seghal, S., Katsandres, S., Dean, S., Khan, A., Krol, O., Jouzestani, M., Huynh, P., Weissman, A., Yealy, D., Scholl, D., Adams, P., McVerry, B., Huang, D., Angus, D., Schooler, J., Moore, S., Files, C., Miller, C., Gibbs, K., LaRose, M., Flores, L., Koehler, L., Morse, C., Sanders, J., Langford, C., Nanney, K., MdalaGausi, M., Yeboah, P., Morris, P., Sturgill, J., Seif, S., Cassity, E., Dhar, S., de Wit, M., Mason, J., Goodwin, A., Hall, G., Grady, A., Chamberlain, A., Brown, S., Bledsoe, J., Leither, L., Peltan, I., Starr, N., Fergus, M., Aston, V., Montgomery, Q., Smith, R., Merrill, M., Brown, K., Armbruster, B., Harris, E., Middleton, E., Paine, R., Johnson, S., Barrios, M., Eppensteiner, J., Limkakeng, A., McGowan, L., Porter, T., Bouffler, A., Leahy, J. C., deBoisblanc, B., Lammi, M., Happel, K., Lauto, P., Self, W., Casey, J., Semler, M., Collins, S., Harrell, F., Lindsell, C., Rice, T., Stubblefield, W., Gray, C., Johnson, J., Roth, M., Hays, M., Torr, D., Zakaria, A., Schoenfeld, D., Thompson, T., Hayden, D., Ringwood, N., Oldmixon, C., Ulysse, C., Morse, R., Muzikansky, A., Fitzgerald, L., Whitaker, S., Lagakos, A., Brower, R., Reineck, L., Aggarwal, N., Bienstock, K., Freemer, M., Maclawiw, M., Weinmann, G., Morrison, L., Gillespie, M., Kryscio, R., Brodie, D., Zareba, W., Rompalo, A., Boeckh, M., Parsons, P., Christie, J., Hall, J., Horton, N., Zoloth, L., Dickert, N., Diercks, D., and National Heart, Lung, and Blood Institute PETAL Clinical Trials Network (2020), “Effect of Hydroxychloroquine on Clinical Status at 14 Days in Hospitalized Patients With COVID-19: A Randomized Clinical Trial,” JAMA, 324, 2165–2176. DOI: 10.1001/jama.2020.22240.
  • Shen, C., Wang, Z., Zhao, F., Yang, Y., Li, J., Yuan, J., Wang, F., Li, D., Yang, M., Xing, L., Wei, J., Xiao, H., Yang, Y., Qu, J., Qing, L., Chen, L., Xu, Z., Peng, L., Li, Y., Zheng, H., Chen, F., Huang, K., Jiang, Y., Liu, D., Zhang, Z., Liu, Y., and Liu, L. (2020), “Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma,” JAMA, 323, 1582–1589. DOI: 10.1001/jama.2020.4783.
  • Skipper, C. P., Pastick, K. A., Engen, N. W., Bangdiwala, A. S., Abassi, M., Lofgren, S. M., Williams, D. A., Okafor, E. C., Pullen, M. F., Nicol, M. R., Nascene, A. A., Hullsiek, K. H., Cheng, M. P., Luke, D., Lother, S. A., MacKenzie, L. J., Drobot, G., Kelly, L. E., Schwartz, I. S., Zarychanski, R., McDonald, E. G., Lee, T. C., Rajasingham, R., and Boulware, D. R. (2020), “Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19,” Annals of Internal Medicine, 173, 623–631. DOI: 10.7326/M20-4207.
  • Sox, H. C., and Goodman, S. N. (2012), “The Methods of Comparative Effectiveness Research,” Annual Review of Public Health, 33, 425–445. DOI: 10.1146/annurev-publhealth-031811-124610.
  • Suvarna, V. R. (2018), “Real World Evidence (RWE) – Are We (RWE) Ready?” Perspectives in Clinical Research, 9, 61–63. DOI: 10.4103/picr.PICR_36_18.
  • Tang, W., Cao, Z., Han, M., Wang, Z., Chen, J., Sun, W., Wu, Y., Xiao, W., Liu, S., Chen, E., Chen, W., Wang, X., Yang, J., Lin, J., Zhao, Q., Yan, Y., Xie, Z., Li, D., Yang, Y., Liu, L., Qu, J., Ning, G., Shi, G., and Xie, Q. (2020), “Hydroxychloroquine in Patients with Mainly Mild to Moderate Coronavirus Disease 2019: Open Label, Randomised Controlled Trial,” BMJ, 369, m1849. DOI: 10.1136/bmj.m1849.
  • The Center For Disease Dynamics, Economics & Policy (2021), available at https://cddep.org/research-area/covid-19/. Accessed October 21, 2021.
  • The RECOVERY Collaborative Group (2020), “Effect of Hydroxychloroquine in Hospitalized Patients with Covid-19,” New England Journal of Medicine, 383, 2030–2040.
  • Tseng, K., Frost, I., Kapoor, G., Sriram, A., Nandi, A., and Laxminarayan, R. (2021), “Covid-19 India: State-Level Estimates of Hospitalization Needs,” available at https://cddep.org/wp-content/uploads/2020/04/Covid.state/_.hosp/_2Apr2020-3-1.pdf. Accessed October 21, 2021.
  • US FDA 21st Century Cures Act (2016), available at https://www.congress.gov/114/plaws/publ255/PLAW-114publ255.pdf. Public Law 114-255: December 13, 2016. Accessed October 21, 2021.
  • US Food & Drug Administration (FDA) (2020), “Coronavirus (COVID-19) Update: Daily Roundup March 30,” available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-daily-roundup-march-30-2020{/#}:/textasciitilde:text=On{/%}20March{/%}2028{/%}2C{/%}202020{/%}2C{/%}20the,hospitalized{/%}20patients{/%}20with{/%}20COVID{/%}2D19. Accessed October 21, 2021.
  • US Food & Drug Administration (FDA) (2020), “Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Chloroquine and Hydroxychloroquine,” June 15, 2020. available at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-chloroquine-and. Accessed October 21, 2021.
  • US Food & Drug Administration (FDA) (2021), “FDA In Brief: FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data. February 4, 2021, available at https://www.fda.gov/news-events/fda-brief/fda-brief-fda-updates-emergency-use-authorization-covid-19-convalescent-plasma-reflect-new-data. Accessed October 21, 2021.
  • Verdonk, C., Verdonk, F., and Dreyfus, G. (2020), “How Machine Learning Could be Used in Clinical Practice During an Epidemic,” Critical Care, 24, 265. DOI: 10.1186/s13054-020-02962-y.
  • Verity, R., Okell, L. C., Dorigatti, I., Winskill, P., Whittaker, C., Imai, N., et al. (2020), “Estimates of the Severity of Coronavirus Disease 2019: A Model-Based Analysis,” Lancet Infectious Diseases, 20, 669–677. DOI: 10.1016/S1473-3099(20)30243-7.
  • Wang, Q., Xie, S., Wang, Y., and Zeng, D. (2020), “Survival-Convolution Models for Predicting COVID-19 Cases and Assessing Effects of Mitigation Strategies,” Frontiers in Public Health, 8, 325. DOI: 10.3389/fpubh.2020.00325.
  • WHO Solidarity Trial Consortium (2021), “Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial,” New England Journal of Medicine., 384, 497–511.
  • Wiens, J., and Shenoy, E. S. (2018), “Machine Learning for Healthcare: On the Verge of a Major Shift in Healthcare Epidemiology,” Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America, 66, 149–153. DOI: 10.1093/cid/cix731.
  • Williamson, E., Morley, R., Lucas, A., and Carpenter, J. (2012), “Propensity Scores: From Naive Enthusiasm to Intuitive Understanding,” Statis- tical Methods in Medical Research, 21, 273–293. DOI: 10.1177/0962280210394483.
  • Winship, C., and Morgan, S. (2014), Counterfactuals and Causal Inference: Methods and Principles for Social Research (2nd ed). Cambridge: Cambridge University Press.
  • World Health Organization (WHO) Archived: WHO Timeline – COVID-19 (2021), available at https://www.who.int/news-room/detail/27-04-2020-who-timeline–-covid-19. Accessed Ocobert 21, 2021.
  • Zeng, Q.-L., Yu, Z.-J., Gou, J.-J., Li, G.-M., Ma, S.-H., Zhang, G.-F., Xu, J.-H., Lin, W.-B., Cui, G.-L., Zhang, M.-M., Li, C., Wang, Z.-S., Zhang, Z.-H., and Liu, Z.-S. (2020), “Effect of Convalescent Plasma Therapy on Viral Shedding and Survival in COVID-19 Patients,” The Journal of Infectious Diseases, 222, 38–43. DOI: 10.1093/infdis/jiaa228.
  • Zhang, B., Liu, S., Tan, T., Huang, W., Dong, Y., Chen, L., Chen, Q., Zhang, L., Zhong, Q., Zhang, X., Zou, Y., and Zhang, S. (2020), “Treatment With Convalescent Plasma for Critically Ill Patients With Severe Acute Respiratory Syndrome Coronavirus 2 Infection,” Chest, 158, e9–e13. DOI: 10.1016/j.chest.2020.03.039.
  • Zhao, S., and Chen, H. (2020), “Modeling the Epidemic Dynamics and Control of COVID-19 Outbreak in China,” Quantitative Biology, 8, 11–19. DOI: 10.1007/s40484-020-0199-0.

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