Abstract:
:The COVID-19 pandemic has substantially impacted the conduct of clinical trials. While initially preparing for a period of time, where it would likely be impossible to supervise trials in the usual way and precautionary measures had to be implemented to care for medication supply and general safety of study participants it is now important to consider, how the impact of the pandemic on trial outcome can be assessed, which measures are needed to decide, how to proceed with the trial and what is needed to compensate to irregularity introduced by the pandemic situation. Obviously not all trials will suffer to the same degree: some trials may be close to finalizing recruitment, others may not yet have started. Similarly not all clinical trials investigate vulnerable patient populations, but some will and may in addition have recruited to an extent that beneficial effects achieved in the initial phase of the trial may be outweighed by an increase e.g. in mortality that impacts both treatment groups. The situation is further complicated by the fact that the pandemic reached different countries in the world and even cities in one country at different points in time with different severity. Our example is a randomized and double-blind clinical trial comparing digitoxin and placebo in patients with advanced chronic heart failure. This trial has recruited roughly 1/3 of the overall 2200 patients when the disease outbreak reached Germany. We discuss how simulations and theoretical considerations can be used to address questions about the need to increase the overall sample-size to be recruited to compensate for a potential shrinkage of the treatment effect caused by the COVID-19 pandemic and what role the degree of consistency could play when comparing pre-, during- and post- COVID-19 periods of trial conduct regarding the question, whether the treatment effect can be considered consistent and with this generalizable. This is dependent on the size of the treatment effect and the impact of the pandemic. We argue, that in case of doubt, it may be wise to proceed with the original study plan.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Großhennig A,Koch Adoi
10.1016/j.cct.2020.106155subject
Has Abstractpub_date
2020-11-01 00:00:00pages
106155eissn
1551-7144issn
1559-2030pii
S1551-7144(20)30233-0journal_volume
98pub_type
杂志文章abstract:BACKGROUND:Laxatives are much utilized, but few clinical trials assessed the efficacy of phytotherapics in the functional constipation. AIM:The aim of this study was to evaluate the efficacy of the tincture of jalapa in the treatment of patients with functional constipation. METHODS:Double-blind, randomized, placebo-...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2010.10.011
更新日期:2011-03-01 00:00:00
abstract::This pilot study examined knowledge, understanding and perceived acceptability of key methodological concepts in clinical trials among injecting drug users (IDUs) in Sydney, Australia. Participants were clinical trial-experienced (n = 17) and trial-naïve (n = 99) IDUs recruited from community needle and syringe progra...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2009.04.002
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.05.003
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2019.105834
更新日期:2019-10-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2019-04-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.04.002
更新日期:2012-07-01 00:00:00
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journal_title:Contemporary clinical trials
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.12.014
更新日期:2018-03-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2009.08.001
更新日期:2010-01-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.04.006
更新日期:2008-01-01 00:00:00
abstract:BACKGROUND:The 9-valent human papillomavirus (HPV) (9vHPV) vaccine targets the four HPV types (6/11/16/18) covered by the licensed quadrivalent HPV (qHPV) vaccine and five additional types (31/33/45/52/58). A large outcome trial of 9vHPV vaccine was conducted. METHODS:An active control (qHPV vaccine) was used because ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2015.02.009
更新日期:2015-05-01 00:00:00
abstract::Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve thei...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.04.003
更新日期:2017-06-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,meta分析
doi:10.1016/j.cct.2019.06.004
更新日期:2019-07-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2009.01.010
更新日期:2009-05-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106240
更新日期:2020-12-07 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2012.07.015
更新日期:2012-11-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.105975
更新日期:2020-04-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2011.10.013
更新日期:2012-03-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.05.012
更新日期:2018-07-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.01.013
更新日期:2016-03-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2019.105816
更新日期:2019-09-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2019.105853
更新日期:2019-11-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.03.004
更新日期:2016-05-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
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更新日期:2020-11-14 00:00:00
abstract::The fraction of patients who respond to treatment and the duration of response in the subset of responding patients are commonly evaluated in oncology trials of cytotoxic compounds. While formal, comparative analysis of the fraction of patients responding to treatment is straightforward in a randomised trial, analyses...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.10.008
更新日期:2008-07-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2011.05.005
更新日期:2011-09-01 00:00:00
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journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2015.12.017
更新日期:2016-03-01 00:00:00
abstract::Numerous studies have attempted to identify successful dietary strategies for weight loss, and many have focused on Low-Fat vs. Low-Carbohydrate comparisons. Despite relatively small between-group differences in weight loss found in most previous studies, researchers have consistently observed relatively large between...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2016.12.021
更新日期:2017-02-01 00:00:00
abstract::Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2006.08.004
更新日期:2007-05-01 00:00:00