Hostname: page-component-8448b6f56d-cfpbc Total loading time: 0 Render date: 2024-04-24T01:22:20.063Z Has data issue: false hasContentIssue false
  • English
  • Français

Characteristics of Clinical Trials Launched Early in the COVID-19 Pandemic in the US and in France

Published online by Cambridge University Press:  21 April 2021

Véronique Raimond ,
Julien Mousquès ,
Jerry Avorn  and
Aaron S. Kesselheim
Get access Rights & Permissions [Opens in a new window]

Abstract

Based on hierarchical classification and logistic regression of early US and French COVID-19 clinical trials we show that despite the registration of a large number of trials, only a minority had characteristics usually associated with providing robust and relevant evidence.

Keywords

COVID-19Clinical TrialUnited StatesFranceHierarchical Classification
Type
Columns: Health Policy Portal
Information
Journal of Law, Medicine & Ethics , Volume 49 , Issue 1: Public Sector and Non-Profit Contributions to Drug Development: Historical Scope, Opportunities, and Challenges , Spring 2021 , pp. 139 - 151
Copyright
© 2021 The Author(s)

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

About This Column

Aaron Kesselheim serves as the editor for Health Policy Portal. Dr. Kesselheim is the JLME editor-in-chief and director of the Program On Regulation, Therapeutics, And Law at Brigham and Women’s Hospital/Harvard Medical School. This column features timely analyses and perspectives on issues at the intersection of medicine, law, and health policy that are directly relevant to patient care. If you would like to submit to this section of JLME, please contact Dr. Kesselheim at akesselheim@bwh.harvard.edu.

References

Bauchner, H. and Fontanarosa, P.B., “Randomized Clinical Trials and COVID-19: Managing Expectations,” JAMA 323, no. 22 (2020): 2262–2263, available at <https://doi.org/10.1001/jama.2020.8115> (last visited February 4, 2021).CrossRefGoogle ScholarPubMed
Macleod, M.R., Michie, S., Roberts, I., Dirnagl, U., Chalmers, I., Ioannidis, J.P.A., et al., “Biomedical Research: Increasing Value, Reducing Waste,” Lancet 383 (2014): 101–104, available at <https://doi.org/10.1016/S0140-6736(13)62329-6> (last visited February 4, 2021).CrossRefGoogle ScholarPubMed
Higgins, J.P.T., Altman, D.G., Gøtzsche, P.C., Jüni, P., Moher, D., Oxman, A.D., et al., “The Cochrane Collaboration’s Tool for Assessing Risk of Bias in Randomised Trials,” BMJ 343 (2011), available at <https://doi.org/10.1136/bmj.d5928> (last visited February 4, 2021).CrossRefGoogle ScholarPubMed
Naci, H. and Ioannidis, J.P.A., “How Good Is “Evidence” from Clinical Studies of Drug Effects and Why Might Such Evidence Fail in the Prediction of the Clinical Utility of Drugs?” Annual Review of Pharmacology and Toxicology 55 (2015): 169–189, available at <https://doi.org/10.1146/annurev-pharmtox-010814-124614> (last visited February 4, 2021); Y. Yordanov, A. Dechartres, I. Atal, V.-T. Tran, I. Boutron, P. Crequit, et al., “Avoidable Waste of Research Related to Outcome Planning and Reporting in Clinical Trials,” BMC Medicine 16 (2018), article, available at <https://doi.org/10.1186/s12916-018-1083-x> (last visited February 5, 2021); R. Ahn, A. Woodbridge, A. Abraham, S. Saba, D. Korenstein, E. Madden, et al., “Financial Ties of Principal Investigators and Randomized Controlled Trial Outcomes: Cross Sectional Study,” BMJ 356 (2017): i6770, available at <https://doi.org/10.1136/bmj.i6770> (last visited February 5, 2021).CrossRefGoogle ScholarPubMed
Lythgoe, M.P. and Middleton, P., “Ongoing Clinical Trials for the Management of the COVID-19 Pandemic,” Trends in Pharmacological Sciences 41, no. 6 (2020), available at <https://doi.org/10.1016/j.tips.2020.03.006> (February 5, 2021).CrossRefGoogle ScholarPubMed
Eichler, H.-G., Cavaleri, M., Enzmann, H., Scotti, F., Sepodes, B., Sweeney, F., et al., “Clinical Trials for Covid-19: Can We Better use the Short Window of Opportunity?” Clinical Pharmacology & Therapeutics Review 108, no. 4 (2020), available at <https://doi.org/10.1002/cpt.1891> (last visited February 5, 2021).Google ScholarPubMed
Chowdhury, M.S., Rathod, J., Gernsheimer, J., “A Rapid Systematic Review of Clinical Trials Utilizing Chloroquine and Hydroxychloroquine as a Treatment for COVID-19,” Academic Emergency Medicine 27, no. 6 (2020): 493–504, available at <https://doi.org/10.1111/acem.14005> (last visited February 5, 2021).CrossRefGoogle ScholarPubMed
Mehta, H.B., Ehrhardt, S., Moore, T.J., Segal, J.B., and Alexander, G.C., “Characteristics of registered clinical trials assessing treatments for COVID-19: a cross-sectional analysis,” BMJ Open 10, no. 6 (2020): e039978, available at <https://doi.org/10.1136/bmjo-pen-2020-039978> (February 5, 2021).CrossRefGoogle ScholarPubMed
Clinical Trials Register n.d, available at <https://www.clinicaltrialsregister.eu/ctr-search/search> (last visited April 23, 2020).+(last+visited+April+23,+2020).>Google Scholar
Pagès, J., Multiple Factor Analysis by Example Using R (Chapman and Hall/ CRC; 2014), available at <https://doi.org/10.1201/b17700> (last visited February 5, 2021).CrossRefGoogle Scholar
Husson, F., Josse, J., Pages, J., “Principal Component Methods-Hierarchical Clustering-Partitional Clustering: Why Would We Need to Choose for Visualizing Data,” Applied Mathematics Department (2010): 1–17.Google Scholar
Pagès, supra note 10; Husson, F., Lê, S., Pages, J., Exploratory Multivariate Analysis by Example Using R (Chapman and Hall/CRC, 2017), available at <https://doi.org/10.1201/b21874> (last visited February 5, 2021).CrossRefGoogle Scholar
Husson, supra note 12; Lê, S., Josse, J., and Husson, F., “FactoMineR: An R Package for Multivariate Analysis,” Journal of Statistical Software 25 (2008): 1–18, available at <https://doi.org/10.18637/jss.v025.i01> (last visited February 5, 2021).CrossRefGoogle Scholar
Bhatt, D.L. and Mehta, C., “Adaptive Designs for Clinical Trials,” New England Journal of Medicine 375 (2016): 65–74, available at <https://doi.org/10.1056/NEJMra1510061> (last visited February 5, 2021).CrossRefGoogle ScholarPubMed
Eichler, supra note 6; Mehta, supra note 8.Google Scholar
Kubota, T., “Open Science in the Era of COVID-19,” Stanford News, April 6, 2020, available at <https://news.stan-ford.edu/2020/04/06/open-science-era-covid-19/> (last visited February 5, 2021).+(last+visited+February+5,+2021).>Google Scholar
Rome, B.N. and Avorn, J., “Drug Evaluation during the Covid-19 Pandemic,” New England Journal of Medicine 382 (2020): 2282–2284, available at <https://doi.org/10.1056/NEJMp2009457> (last visited February 5, 2021).CrossRefGoogle ScholarPubMed
“Covid-19: Sur les essais cliniques, l’Europe est un échec,” Le Monde, May 4, 2020.Google Scholar
Cleary, E.G., Beierlein, J.M., Khanuja, N.S., McNamee, L.M., and Ledley, F.D., “Contribution of NIH Funding to New Drug Approvals 2010-2016,” PNAS 115 (2018): 2329–2334, available at <https://doi.org/10.1073/pnas.1715368115> (last visited February 5, 2021); M. Damgé, “Qui profite du crédit d’impôt recherche?” Le Monde, September 6, 2016.CrossRefGoogle Scholar
Emergency Access to Remdesivir Outside of Clinical Trials n.d., available at <https://www.gilead.com/purpose/advancing-global-health/covid-19/emergency-access-to-remdesivir-out-side-of-clinical-trials> (last visited February 5, 2021).+(last+visited+February+5,+2021).>Google Scholar
Francisco, E.M., “EMA Provides Recommendations on Compassionate use of remdesivir for COVID-19,” European Medicines Agency, March 4, 2020, available at <https://www.ema.europa.eu/en/news/ema-provides-recommen-dations-compassionate-use-remdesi-vir-covid-19> (last visited February 5, 2021).+(last+visited+February+5,+2021).>Google Scholar
DeVito, N.J., Bacon, S., and Goldacre, B., “Compliance with Legal Requirement to Report Clinical Trial Results on ClinicalTrials.gov: A Cohort Study,” The Lancet 395, no. no. 10221 (2020): 361–369, available at <https://doi.org/10.1016/S0140-6736(19)33220-9> (last visited February 5, 2021).CrossRefGoogle ScholarPubMed
Eichler, supra note 6; Wang, Y., Zhang, D., Du, G., Du, R., Zhao, J., Jin, Y., et al., “Remdesivir in Adults with Severe COVID-19: A Randomised, Double-Blind, Placebo-Controlled, Multicentre Trial,” The Lancet 395, no. 10236 (2020): 1569–1578, available at <https://doi.org/10.1016/S0140-6736(20)31022-9> (last visited February 5, 2021).CrossRefGoogle ScholarPubMed
ANSM, “COVID-19 : l’ANSM souhaite suspendre par précaution les essais cliniques évaluant l’hydroxychloroquine dans la prise en charge des patients - Point d’Information,” ANSM : Agence nationale de sécurité du médicament et des produits de santé (2020).Google Scholar
Fanelli, D., “Negative Results are Disappearing from Most Disciplines and Countries,” Scientometrics 90 (2012): 891–904, available at <https://doi.org/10.1007/s11192-011-0494-7> (last visited February 5, 2021).CrossRefGoogle Scholar
Boyer, L., Auquier, P., and Fond, G., “Real-life data and Covid-19: The third avenue of reseach,” L’Encéphale 46, no. 3, Supplement (2020): S114–S115, available at <https://doi.org/10.1016/j.encep.2020.04.003> (last visited February 5, 2021).CrossRefGoogle ScholarPubMed
“Veille des études cliniques publiées pour certains médicaments de la Covid-19,” Haute Autorité de Santé n.d., available at <https://has-sante.fr/jcms/p_3186049/fr/veille-des-etudes-cliniques-publiees-pour-certains-me-dicaments-de-la-covid-19> (last visited February 3, 2021).+(last+visited+February+3,+2021).>Google Scholar