新冠疫情给药物研发带来的挑战：临床药理学的机遇。
Challenges in Drug Development Posed by the COVID-19 Pandemic: An Opportunity for Clinical Pharmacology.
机构信息
EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.
Business of Merck KGaA, Darmstadt, Germany.
出版信息
Clin Pharmacol Ther. 2020 Oct;108(4):699-702. doi: 10.1002/cpt.1879. Epub 2020 May 28.
Abstract
The unprecedented challenges posed by the coronavirus disease 2019 (COVID-19) pandemic highlight the urgency for applying clinical pharmacology and model-informed drug development in (i) dosage optimization for COVID-19 therapies, (ii) approaching therapeutic dilemmas in clinical trial settings, and (iii) maximizing value of information from impacted non-COVID-19 trials. More than ever, we have a responsibility for adaptive evidence synthesis with a Totality of Evidence mindset in this race against time across biomedical research, clinical practice, drug development, and regulation.
摘要
由 2019 年冠状病毒病（COVID-19）大流行带来的前所未有的挑战突显了临床药理学和基于模型的药物开发在以下方面的紧迫性：（i）COVID-19 治疗的剂量优化，（ii）在临床试验环境中解决治疗难题，以及（iii）从受影响的非 COVID-19 试验中最大限度地获取信息。在这场与时间赛跑的生物医学研究、临床实践、药物开发和监管的竞赛中，我们比以往任何时候都更有责任采用基于全证据的适应性证据综合方法。
相似文献
1
Challenges in Drug Development Posed by the COVID-19 Pandemic: An Opportunity for Clinical Pharmacology.
Clin Pharmacol Ther. 2020 Oct;108(4):699-702. doi: 10.1002/cpt.1879. Epub 2020 May 28.
2
COVID-19: A Defining Moment for Clinical Pharmacology?
Clin Pharmacol Ther. 2020 Jul;108(1):11-15. doi: 10.1002/cpt.1876.
3
Developing Covid-19 Vaccines at Pandemic Speed.
N Engl J Med. 2020 May 21;382(21):1969-1973. doi: 10.1056/NEJMp2005630. Epub 2020 Mar 30.
4
The coronavirus outbreak could make it quicker and easier to trial drugs.
Nature. 2020 Jun;582(7811):172. doi: 10.1038/d41586-020-01524-0.
5
In the COVID-19 era, let's keep an eye on clinical trials in Africa.
J Glob Health. 2020 Dec;10(2):020312. doi: 10.7189/jogh.10.020312.
6
Panic prescribing has become omnipresent during the COVID-19 pandemic.
J Clin Invest. 2020 Jun 1;130(6):2752-2753. doi: 10.1172/JCI139562.
7
Covid-19 vaccine trial protocols released.
BMJ. 2020 Oct 21;371:m4058. doi: 10.1136/bmj.m4058.
8
Time to Step Up: A Call to Action For the Clinical and Quantitative Pharmacology Community to Accelerate Therapeutics for COVID-19.
Clin Transl Sci. 2020 Jul;13(4):646-648. doi: 10.1111/cts.12824. Epub 2020 Jun 11.
9
COVID-19: Small-Molecule Clinical Trials Landscape.
Curr Top Med Chem. 2020;20(18):1577-1580. doi: 10.2174/156802662018200703154334.
10
The future of cancer research after COVID-19 pandemic: recession?
Future Oncol. 2020 Jul;16(21):1493-1495. doi: 10.2217/fon-2020-0397. Epub 2020 May 29.
引用本文的文献
1
Monkeypox: a review of epidemiological modelling studies and how modelling has led to mechanistic insight.
Epidemiol Infect. 2023 May 23;151:e121. doi: 10.1017/S0950268823000791.
2
A connection between survival multistate models and causal inference for external treatment interruptions.
Stat Methods Med Res. 2023 Feb;32(2):267-286. doi: 10.1177/09622802221133551. Epub 2022 Dec 4.
3
Pharmacokinetic considerations to optimize clinical outcomes for COVID-19 drugs.
Trends Pharmacol Sci. 2022 Dec;43(12):1041-1054. doi: 10.1016/j.tips.2022.09.005. Epub 2022 Sep 26.
4
How resilient were we in 2021? Results of a LinkedIn Survey including biomedical and pharmaceutical professionals using the Benatti Resiliency Model.
Clin Transl Sci. 2022 Oct;15(10):2355-2365. doi: 10.1111/cts.13364. Epub 2022 Aug 18.
5
Applying Modeling and Simulations for Rational Dose Selection of Novel Toll-Like Receptor 7/8 Inhibitor Enpatoran for Indications of High Medical Need.
Clin Pharmacol Ther. 2022 Aug;112(2):297-306. doi: 10.1002/cpt.2606. Epub 2022 May 21.
6
Evidence-time dilemma in a pandemic with high mortality: Can outcome-driven decision making on vaccines prevent deaths?
Clin Transl Sci. 2022 Jan;15(1):5-8. doi: 10.1111/cts.13155. Epub 2021 Sep 28.
7
Application of Machine Learning in Translational Medicine: Current Status and Future Opportunities.
AAPS J. 2021 May 18;23(4):74. doi: 10.1208/s12248-021-00593-x.
8
Clinical Characteristics of 3 Patients Infected with COVID-19: Age, Interleukin 6 (IL-6), Lymphopenia, and Variations in Chest Computed Tomography (CT).
Am J Case Rep. 2020 Oct 14;21:e924905. doi: 10.12659/AJCR.924905.
9
Immunomodulatory Therapeutic Proteins in COVID-19: Current Clinical Development and Clinical Pharmacology Considerations.
J Clin Pharmacol. 2020 Oct;60(10):1275-1293. doi: 10.1002/jcph.1729. Epub 2020 Sep 8.
10
A Real-World Evidence Framework for Optimizing Dosing in All Patients With COVID-19.
Clin Pharmacol Ther. 2020 Nov;108(5):921-923. doi: 10.1002/cpt.1922. Epub 2020 Jun 29.
本文引用的文献
1
Off-Label Therapies for COVID-19-Are We All In This Together?
Clin Pharmacol Ther. 2020 Aug;108(2):182-184. doi: 10.1002/cpt.1862. Epub 2020 May 5.
2
Optimizing Hydroxychloroquine Dosing for Patients With COVID-19: An Integrative Modeling Approach for Effective Drug Repurposing.
Clin Pharmacol Ther. 2020 Aug;108(2):253-263. doi: 10.1002/cpt.1856. Epub 2020 May 12.
3
Considerations for Drug Interactions on QTc in Exploratory COVID-19 Treatment.
Circulation. 2020 Jun 16;141(24):e906-e907. doi: 10.1161/CIRCULATIONAHA.120.047521. Epub 2020 Apr 8.
4
Towards Optimization of Hydroxychloroquine Dosing in Intensive Care Unit COVID-19 Patients.
Clin Infect Dis. 2020 Nov 19;71(16):2227-2229. doi: 10.1093/cid/ciaa394.
5
Coronavirus Disease 2019 (COVID-19): Do Angiotensin-Converting Enzyme Inhibitors/Angiotensin Receptor Blockers Have a Biphasic Effect?
J Am Heart Assoc. 2020 Apr 7;9(7):e016509. doi: 10.1161/JAHA.120.016509. Epub 2020 Apr 1.
6
In Vitro Antiviral Activity and Projection of Optimized Dosing Design of Hydroxychloroquine for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).
Clin Infect Dis. 2020 Jul 28;71(15):732-739. doi: 10.1093/cid/ciaa237.
7
Multistate modeling of clinical hold in randomized clinical trials.
Pharm Stat. 2020 May;19(3):262-275. doi: 10.1002/pst.1989. Epub 2019 Dec 10.
8
Wearable Devices in Clinical Trials: Hype and Hypothesis.
Clin Pharmacol Ther. 2018 Jul;104(1):42-52. doi: 10.1002/cpt.966. Epub 2018 Apr 2.
Zotero 插件