7. REFERENCES
- Austin P., Fine J. (2017) “Accounting for competing risks in randomized controlled trials: a review and recommendations for improvement,” Statistics in Medicine, 36, 1203-1209.
- Cao B., Wang Y., Wen D. et al. (2020) “A Trial of Lopinavir–Ritonavir in Adults Hospitalized with Severe Covid-19,” New England Journal of Medicine, 1-13, DOI: 10.1056/NEJMoa2001282, accessed 12May2020.
- EU Clinical Trials Register (2020) EudraCT protocol 2020-001736-95 (available at https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-001736-95+, accessed 24 June 2020).
- Food and Drug Administration (FDA) (May 2020) COVID-19: Developing Drugs and Biological Products for Treatment or Prevention, https://www.fda.gov/media/137926/download, accessed 15May2020.
- Gray R. (1988) “Class of K-sample tests for comparing the cumulative inci dence of a competing risk”. Annals of Statistics, 1141-1154.
- Grein J., Ohmagari N., Shin D. et al. (2020) “Compassionate Use of Remdesivir for Patients with Severe Covid-19,” New England Journal of Medicine, 1-10, DOI: 10.1056/NEJMoa2007016, accessed 12May2020.
- International Council for Harmonisation (ICH) (2019) Addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials E9(R1), available at https://www.fda.gov/media/108698/download, accessed 04August2020
- National Institute of Health (2020) Identifier NCT04280705, available at clinicaltrials.gov identifier, accessed 24 June 2020.
- Peterson R., Vock D., Powers J., Emery S., Cruz E., Hunsberger S., Jain M., Pett S., Neaton J. for the INSIGHT FLU-IVIG Study Group (2017) “Analysis of an ordinal endpoint for use in evaluating treatments for severe influenza requiring hospitalization,” Clinical Trials, 14(3) 264-276.
- Powers J., Patrick D., Walton M., Marguis P., Cano S., Hobart J., Isaac M., Vamvakas S., Slagle A., Molsen E., Burke L. (2017) “Clinician-Reported Outcome Assessments of Treatment Benefit: Report of the ISPOR Clinical Outcome Assessment Emerging Good Practices Task Force,” Value in Health, 20, 2-14.
- Varadhan R., Weiss C., Segal J., Wu A., Scharfstein D., Boyd C. (2010) “Evaluating Health Outcomes in the Presence of Competing Risks: A Review of Statistical Methods and Clinical Applications,” Medical Care 48, S96-S105.
- von Cube M., Grodd M., Wolkewitz M., Hazard D., Lambert J. (2020) “Harmonizing Heterogeneous Endpoints in COVID-19 Trials Without Loss of Information – an Essential Step to Facilitate Decision Making,” medRxiv preprint, DOI: https://doi.org/10.1101/2020.03.31.20049007, accessed 12May2020.
- World Health Organisation (2020a) WHO R&D Blueprint Novel Coronavirus COVID-19 Therapeutic Trial Synopsis, available at https://www.who.int/blueprint/priority-diseases/key-action/COVID-19_Treatment_Trial_Design_Master_Protocol_synopsis_Final_18022020.pdf, accessed 12May2020.
- World Health Organisation (2020b) Quasi-experimental studies: description of primary studies, available at https://covid-nma.com/living_data/index.php, accessed 22Jun2020.
- World Health Organisation (2020c) Observational studies: pharmacologic treatments, available at https://covid-nma.com/observational_studies/index.php?intervention=1, accessed 22Jun2020.