Operational Experiences in China and Statistical Issues on the Conduct of Clinical Trials During the COVID-19 Pandemic

Guo, Tong; Chen, Chian; Chiang, Chieh; Chen, Chi-Tian

doi:10.1080/19466315.2020.1797866

Cited by 4 publications

(5 citation statements)

References 9 publications

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“…In many EU member states, telemedical physician-patient interactions are permitted, thus the frequency of personal follow-up visits can be reduced if not completely avoided [9]. Many studies during the COVID-19 pandemic have recommended the option of using telemedicine, as trial participants may not be able to visit the site for protocol-specific visits [11,13,14,[18][19][20]. Telemedicine has been used effectively during the COVID-19 pandemic, at our site as well.…”

Section: Discussionmentioning

confidence: 99%

Impact of coronavirus disease-19 pandemic on pediatric vaccine clinical trials

Hanumante¹,

Desale²

2021

Indian J Child Health

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T he World Health Organization declared coronavirus disease (COVID)-19 a public health emergency of international concern on January 30, 2020, and later declared a pandemic on March 11, 2020 [1]. The first confirmed case of coronavirus in Maharashtra was reported on March 9, 2020, in our city of Pune. Gradually, the pandemic spreads to all parts of the country, and eventually, the tally of COVID-19 cases by December 2020 touched 10 million.The COVID-19 pandemic has affected nearly every facet of life, including clinical research and has had an adverse and extensive impact on clinical trials including pediatric vaccine trials. Across the globe, countries implemented a variety of restrictions to people's everyday lives which included, countrywide lockdowns, and social distancing, which have been major detrimental factors for the conduct of pediatric vaccine trials [2]. The present study was proposed to assess the impact of the COVID-19 pandemic on enrollment and follow-up of clinical trial participants in pediatric vaccine clinical trials and simultaneously to explore various strategies used for overcoming these challenges during the COVID-19 pandemic. MATERIALS AND METHODSThis observational, cross-sectional study was conducted in the Clinical Research Unit of a tertiary care multispecialty hospital in Pune, where pediatric vaccine clinical trials are routinely

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Section: Discussionmentioning

confidence: 99%

Impact of coronavirus disease-19 pandemic on pediatric vaccine clinical trials

Hanumante¹,

Desale²

2021

Indian J Child Health

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“…New reporting items and recommendations for randomized trials impacted by COVID-19 and force majeure events: a targeted approach To mitigate the spread of COVID-19, strict social distancing and prolonged lockdown measures were implemented in many countries. During the ongoing pandemic crisis, despite adaptations such as remote data collection and monitoring (2), the willingness and ability to participate in cancer clinical trials have been adversely affected (3,4). Therefore, the conduct of clinical trials may be significantly impacted (5)(6)(7).…”

Section: Original Articlementioning

confidence: 99%

“…Thirty-five original articles were included in this study, and five were published in JAMA Oncology, 14 in the Journal of Clinical Oncology, and 16 in The Lancet Oncology (Figure 2). • Post-hoc analysis [2] • Update [2] • Quality-of-life study [1]…”

Section: Study Selection and Time Trendmentioning

confidence: 99%

New reporting items and recommendations for randomized trials impacted by COVID-19 and force majeure events: a targeted approach

Leung¹,

Ho²,

Helali³

et al. 2023

Ann Transl Med

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Background: Appropriate analyses and reporting are essential to the reproducibility and interpretation of clinical trials. However, the coronavirus disease 19 (COVID-19) pandemic and other force majeure events, like the war in Ukraine, have impacted the conduct of clinical trials. Methods:The number of clinical trials potentially impacted were estimated from clinicaltrials.gov. To identify reporting items considered vital for assessing the impact of COVID-19, we reviewed 35 randomized phase III trials from three top oncology journals published between July and December 2020. For validation, we reviewed 29 phase III trials published between January and December 2021.Results: Our results show that the number of clinical trials being potentially impacted in cancer, cardiovascular diseases, and diabetes is at least 1,484, 535, and 145, respectively. The magnitude of disruption is most significant in oncology trials. Based on the review of 35 trials, a modified checklist with ten new and four modified items covering pandemic's impact on trial conduct, protocol changes, delays, data capture, analysis and interpretation was developed to ensure comprehensive and transparent reporting. Our validation shows that six out of seven applicable reporting items were reported in less than 21% of the articles.Conclusions: Our recommendations were proposed to improve the reporting of randomized clinical trials impacted by COVID-19 and force majeure events that are broadly applicable to different areas of medical research.

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“…Guo et al. ( 2020 ) address some statistical issues and operational experiences in the conduct of clinical trials during the COVID-19 pandemic and share their experiences from remote clinical trials in China. Wiens and Lipkovich ( 2020 ) provide recommendations on how sponsors can maximize the chance that a non-inferiority trial conducted during the COVID-19 pandemic gives useful information.…”

mentioning

confidence: 99%

“…Reflecting on the impact of the COVID-19 pandemic in oncology trials, Degtyarev et al (2020) identify key intercurrent events that may occur due to the pandemic in oncology clinical trials and discuss considerations pertaining to the estimand framework introduced in the ICH E9 addendum (ICH 2019). Guo et al (2020) address some statistical issues and operational experiences in the conduct of clinical trials during the COVID-19 pandemic and share their experiences from remote clinical trials in China. Wiens and Lipkovich (2020) provide recommendations on how sponsors can maximize the chance that a non-inferiority trial conducted during the COVID-19 pandemic gives useful information.…”

mentioning

confidence: 99%

Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic

Hamasaki

Bretz

Cooner

et al. 2020

Statistics in Biopharmaceutical Research

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The COVID-19 pandemic has influenced the world in a way that none of us could have imagined. Since February 2020 unplanned changes to daily routines due to the mandatory isolation and social distancing requirements have occurred across the globe. It is the greatest global healthcare crisis of our generation. The COVID-19 pandemic presents enormous challenges in particular to medical research, as these disruptions have wreaked havoc on clinical trials in progress as well as those in the planning stages. For example, the COVID-19 pandemic is reducing the ability and willingness of trial subjects and staff to access clinical sites, disrupting timely data collection or necessitating a move to virtual data collection. These challenges may result in difficulties in complying with protocol-specific procedures, including administration or use of the investigational product or compliance with protocol-required visits, efficacy assessments, and laboratory/diagnostic tests. In many situations, these challenges cause delays or halting of clinical trials altogether.In recognition of these unprecedented challenges, we decided to dedicate a Special Issue of Statistics in Biopharmaceutical Research to the statistical challenges in the conduct and management of ongoing clinical trials during the COVID-19 pandemic. This special issue highlights and discusses critically important topics, including the impact on trial integrity and interpretability, issues around trial management and operations, estimands and missing data handling as well as the application of novel trial designs and analysis approaches. This Special Issue consists of peer-reviewed articles and commentaries, reflecting the vibrancy of ideas and discussions around the COVID-19 pandemic.Meyer et al. ( 2020) put forward a number of strategies and recommendations to assess and address issues related to estimands, missing data, validity and modifications of statistical analysis methods, need for additional analyses, ability to meet objectives as well as overall trial interpretability. This article has been translated into Japanese by the Data Science Expert Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) and available on their website (JPMA 2020). Collins and Levenson (2020) as well as Hemmings (2020) provide insightful regulatory commentaries on the article by Meyer et al. (2020). Akacha et al. (2020) discuss implications of the COVID-19

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Operational Experiences in China and Statistical Issues on the Conduct of Clinical Trials During the COVID-19 Pandemic

Cited by 4 publications

References 9 publications

Impact of coronavirus disease-19 pandemic on pediatric vaccine clinical trials

Impact of coronavirus disease-19 pandemic on pediatric vaccine clinical trials

New reporting items and recommendations for randomized trials impacted by COVID-19 and force majeure events: a targeted approach

Statistical Challenges in the Conduct and Management of Ongoing Clinical Trials During the COVID-19 Pandemic

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