Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19

Nilsson, Mary; Crowe, Brenda; Anglin, Greg; Ball, Greg; Munsaka, Melvin; Shahin, Seta; Wang, Wei

doi:10.1080/19466315.2020.1804444

Cited by 5 publications

(3 citation statements)

References 21 publications

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“…The COVID-19 pandemic and the related measures have also the potential to impact the types, incidence, severity and duration of AEs collected for investigational treatments and in control groups, for example, when subjects take concomitant medications to treat COVID-19 symptoms or when subjects that do not want to leave the house refrain from seeking medical advice when suffering from side effects (Nilsson et al. 2020 ). As in the case of efficacy data, the complications and intercurrent events listed in Section 2 are also relevant when considering safety data, for example, they may lead to some under- or over-reporting of some events.…”

Section: Discussionmentioning

confidence: 99%

Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials

Akacha

Branson

Bretz

et al. 2020

Statistics in Biopharmaceutical Research

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The COVID-19 pandemic has a global impact on the conduct of clinical trials of medical products. This article discusses implications of the COVID-19 pandemic on clinical research methodology aspects and provides points to consider to assess and mitigate the risk of seriously compromising the integrity and interpretability of clinical trials. The information in this article will support discussions that need to occur cross-functionally on an ongoing basis to "integrate all available knowledge from the ethical, the medical, and the methodological perspective into decision making. " This article aims at facilitating: (i) risk assessments of the impact of the pandemic on trial integrity and interpretability; (ii) identification of the relevant data and information related to the impact of the pandemic on the trial that needs to be collected; (iii) short-term decision making impacting ongoing trial operations; (iv) ongoing monitoring of the trial conduct until completion, including the possible involvement of data monitoring committees, and adequately documenting all measures taken to secure trial integrity throughout and after the pandemic, and (v) proper analysis and interpretation of the eventual interim or final trial data.

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Section: Discussionmentioning

confidence: 99%

Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials

Akacha

Branson

Bretz

et al. 2020

Statistics in Biopharmaceutical Research

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“…Complementing the above body of work on efficacy analyses, Nilsson et al. ( 2020 ) provide guidance on how analyses and reporting of clinical trial safety data may need to be modified, given the potential impact from the COVID-19 pandemic. Finally, Zame et al.…”

mentioning

confidence: 99%

“…Building on Kunz et al (2020), the article by Stallard et al (2020) review efficient adaptive designs for clinical trials of interventions for COVID-19. Complementing the above body of work on efficacy analyses, Nilsson et al (2020) provide guidance on how analyses and reporting of clinical trial safety data may need to be modified, given the potential impact from the COVID-19 pandemic. Finally, Zame et al (2020) describe the impact that COVID-19 is having on clinical trials, and reveal potential applications of state-of-the-art machine learning approaches, in three areas: ongoing clinical trials for drugs unrelated to COVID-19, trials for repurposing drugs to treat COVID-19, and trials for new drugs to treat COVID-19.…”

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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Fragment-based drug design of novel inhibitors targeting lipoprotein (a) kringle domain KIV-10-mediated cardiovascular disease

Alsieni,

Esmat,

Bazuhair

et al. 2024

J Bioenerg Biomembr

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Clinical Trial Drug Safety Assessment for Studies and Submissions Impacted by COVID-19

Cited by 5 publications

References 21 publications

Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials

Challenges in Assessing the Impact of the COVID-19 Pandemic on the Integrity and Interpretability of Clinical Trials

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

Fragment-based drug design of novel inhibitors targeting lipoprotein (a) kringle domain KIV-10-mediated cardiovascular disease

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