scholarly journals General characteristics and reasons for the discontinuation of drug clinical trials in mainland China

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Ben-nian Huo ◽  
Mao-lin Ai ◽  
Yun-tao Jia ◽  
Yao Liu ◽  
Yang Wang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Drug Evaluation ◽  
Mainland China ◽  
Strategic Decision ◽  
Large Sample Size ◽  
Cross Sectional ◽  
Large Sample ◽  
Trial Conduct ◽  
Trial Discontinuation

Abstract Background Although discontinuation is common in clinical trials, no study has been conducted to analyse the current situation and reasons for the suspension or discontinuation of drug clinical trials in China. This study aims to analyse the general characteristics and reasons for the discontinuation of registered clinical trials in mainland China and to identify the associated factors. Methods We conducted a cross-sectional observational study of discontinued trials registered in the Drug Trial Registration and Information Publication Platform before March 31, 2020. All trials with a status of terminated or stopped recorded in the platform were classified as discontinued trials and included in the analysis. The basic characteristics of the discontinued trials were recorded, reasons for trial discontinuation were recorded and divided into 4 categories as drug development strategy, trial planning, trial conduct and studied drug. Pearson’s chi-square test and fisher’s exact test were used to compare the differences in reasons for discontinuation between neoplasm trials and non-neoplasm trials, and to examine the associations of trial characteristics with different reasons related to trials discontinuation. Results Three hundred twelve discontinued trials were included in this study. The studied drugs were mainly chemical drugs [229 (73.4%)], and indications of the studied drugs were mainly neoplasms [77 (24.7%)]. Geographical location of the discontinued trials were mostly in northern [114 (36.5%)] and eastern [96 (30.8%)] China. Study type of the included trials was mainly bioequivalence studies [97 (31.1%)]. The most common reason for trial discontinuation was commercial or strategic decision [84 (26.9%)], followed by futility/lack of efficacy [70 (22.4%)]. The number of trial centers, sample size and whether participants had been enrolled were significantly associated with trial discontinuation (P <  0.05). Multiple center trials showed a higher rate of trial discontinuation due to trial conduct related reasons than single center trials (P <  0.05), trials with sample size > 500 showed a higher rate of trial discontinuation due to studied drug related reasons (P < 0.05), and trials enrolled participants showed a lower rate of trial discontinuation due to commercial or strategic decision and a higher rate of trial discontinuation due to studied drug related reasons than trials without enrolled participants (P < 0.05). Besides, neoplasm trials showed a higher rate of trial discontinuation due to poor recruitment and safety comparing with non-neoplasm trials (P < 0.05). Conclusions Trial discontinuation in China mainly occurred because of commercial or strategic decision and futility/lack of efficacy of the studied drug. Clinical trials with multiple centers and a large sample size may more likely be discontinued due to trial conduct related reasons such as good clinical practice. Discontinuation due to drug safety and lack of efficacy in multiple center trials with a large sample size deserves more attention to avoid resources wastes. Full communication with regulatory authorities such as Center for Drug Evaluation and research institutes to develop a feasible protocol is important for sponsors to avoid trial discontinuation due to protocol issues.

scholarly journals Inpatient Satisfaction and Effecting Factors: Findings from a Large Sample Size Cross Sectional Study

2016 ◽  
Vol 1 (1) ◽  
pp. 1-2 ◽  
Author(s):  
Mohammad Gholami Fesharaki ◽  
Hesam Akbari ◽  
Hamed Akbari ◽  
Masome Mohammadian
Keyword(s):  
Sample Size ◽  
Cross Sectional Study ◽  
Large Sample Size ◽  
Sectional Study ◽  
Cross Sectional ◽  
Large Sample

scholarly journals Risk factors for post-ERCP pancreatitis: a systematic review of clinical trials with a large sample size in the past 10 years

2014 ◽  
Vol 19 (1) ◽  
pp. 26 ◽  
Author(s):  
Jian-Jun Chen ◽  
Xi-Mo Wang ◽  
Xing-Qiang Liu ◽  
Wen Li ◽  
Mo Dong ◽  
...  
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Clinical Trials ◽  
Sample Size ◽  
Large Sample Size ◽  
Large Sample ◽  
The Past

A PLEA FOR SIMPLICITY AND LARGE SAMPLE SIZE

PEDIATRICS ◽  
1994 ◽  
Vol 94 (6) ◽  
pp. 823-823
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Sample Size ◽  
Large Scale ◽  
Large Sample Size ◽  
Large Sample ◽  
Health Care Interventions ◽  
Scientific Value

"Most [clinical] trials would be of much greater scientific value if they collected ten times less data, both at entry and during follow-up, and were therefore much larger. Peto R, Collins R, Gray R. Large-scale randomized evidence: large, simple trials and overviews of trials. In: Warren KS, Mosteller F, eds. Doing More Good Than Harm: The Evaluation of Health Care Interventions."

scholarly journals General Characteristics and Reasons for the Discontinuation of Drug Clinical Trials in Mainland China

2020 ◽  
Author(s):  
Ben-nian Huo ◽  
Mao-lin Ai ◽  
Yun-tao Jia ◽  
Yao LIU ◽  
Nan-ge Yin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Sample Size ◽  
Study Design ◽  
Mainland China ◽  
Research Centre ◽  
Careful Study ◽  
Business Decisions ◽  
Negative Results ◽  
Study Type ◽  
Trial Discontinuation

Abstract Background: Although discontinuation is common in clinical trials, no study has been conducted to analyse the current situation and reasons for the suspension or discontinuation of drug clinical trials in China. This study aims to analyse the general characteristics and reasons for the discontinuation of registered clinical trials in mainland China and to identify the associated factors.Methods: Trials with a status of terminated or stopped in the Drug Trial Registration and Information Publication Platform before March 31, 2020, were classified as discontinued trials and included in the analysis. Information related to researchers, studied drugs, the trials and the reasons for discontinuation were recorded. Fisher’s exact and χ2 tests were used to examine the associations of trial characteristics with different issues related to trial discontinuation. Results: Three hundred and twelve discontinued trials were included in this study. The studied drugs were mainly chemical drugs [229 (73.4%)]. The indications of the studied drugs were mainly neoplasms [77 (24.7%)]. The study type was mainly bioequivalence studies [97 (31.1%)]. More than half [177 (56.7%)] of the trials were discontinued because of trial issues, among which the main causes were negative results [69 (22.1%)], protocol issues [41 (13.1%)], and poor recruitment [35 (11.2%)]. Ninety-five (30.4%), 15 (4.8%) and 26 (8.3%) trials were discontinued because of sponsor issues, research centre issues and administration issues, respectively. Study design, blinding status, number of centres, planned sample size and whether participants had been enrolled may have been associated with one to three of the issues related to trial discontinuation.Conclusions: Discontinuation of clinical trials was commonly due to trial issues, sponsor issues, research centre issues and administration issues, such as negative results, and protocol issues. Study design, the number of centres, and sample size may be related to the discontinuation of trials. Careful study designs, smart business decisions, sufficient preparation of supplies such as the research drugs, and whether research centres have enough availability and patients are factors that should be considered before conducting trials.

scholarly journals Feasibility of Race by Sex Intersectionality Research on Suicidality in the Adolescent Brain Cognitive Development (ABCD) Study

Children ◽  
2021 ◽  
Vol 8 (6) ◽  
pp. 437
Author(s):  
Shervin Assari ◽  
Shanika Boyce ◽  
Mohsen Bazargan
Keyword(s):  
Cognitive Development ◽  
Sample Size ◽  
Child Behavior Checklist ◽  
Reliability And Validity ◽  
Self Report ◽  
Large Sample Size ◽  
Cross Sectional ◽  
Cronbach Alpha ◽  
Rich Data ◽  
Suicidal Ideas

Intersectional research on childhood suicidality requires studies with a reliable and valid measure of suicidality, as well as a large sample size that shows some variability of suicidality across sex by race intersectional groups. Objectives: We aimed to investigate the feasibility of intersectionality research on childhood suicidality in the Adolescent Brain Cognitive Development (ABCD) study. We specifically explored the reliability and validity of the measure, sample size, and variability of suicidality across sex by race intersectional groups. Methods: We used cross-sectional data (wave 1) from the ABCD study, which sampled 9013 non-Hispanic white (NHW) or non-Hispanic black (NHB) children between the ages of 9 and 10 between years 2016 and 2018. Four intersectional groups were built based on race and sex: NHW males (n = 3554), NHW females (n = 3158), NHB males (n = 1164), and NHB females (n = 1137). Outcome measure was the count of suicidality symptoms, reflecting all positive history and symptoms of suicidal ideas, plans, and attempts. To validate our measure, we tested the correlation between our suicidality measure and depression and Child Behavior Checklist (CBCL) sub-scores. Cronbach alpha was calculated for reliability across each intersectional group. We also compared groups for suicidality. Results: We observed some suicidality history in observed 3.2% (n = 101) of NHW females, 4.9% (n = 175) of NHW males, 5.4% (n = 61) of NHB females, and 5.8% (n = 68) of NHB males. Our measure’s reliability was acceptable in all race by sex groups (Cronbach alpha higher than .70+ in all intersectional groups). Our measure was valid in all intersectional groups, documented by a positive correlation with depression and CBCL sub-scores. We could successfully model suicidality across sex by race groups, using multivariable models. Conclusion: Given the high sample size, reliability, and validity of the suicidality measure, variability of suicidality, it is feasible to investigate correlates of suicidality across race by sex intersections in the ABCD study. We also found evidence of higher suicidality in NHB than NHW children in the ABCD study. The ABCD rich data in domains of social context, self-report, schools, parenting, psychopathology, personality, and brain imaging provides a unique opportunity to study intersectional differences in neural circuits associated with youth suicidality.

scholarly journals Effect of redundant clinical trials from mainland China evaluating statins in patients with coronary artery disease: cross sectional study

BMJ ◽  
2021 ◽  
pp. n48
Author(s):  
Yuanxi Jia ◽  
Jiajun Wen ◽  
Riaz Qureshi ◽  
Stephan Ehrhardt ◽  
David D Celentano ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Clinical Trials ◽  
Coronary Artery ◽  
Confidence Interval ◽  
Randomized Clinical Trials ◽  
Mainland China ◽  
Statin Treatment ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Artery Disease

Abstract Objective To identify redundant clinical trials evaluating statin treatment in patients with coronary artery disease from mainland China, and to estimate the number of extra major adverse cardiac events (MACEs) experienced by participants not treated with statins in those trials. Design Cross sectional study. Setting 2577 randomized clinical trials comparing statin treatment with placebo or no treatment in patients with coronary artery disease from mainland China, searched from bibliographic databases to December 2019. Participants 250 810 patients with any type of coronary artery disease who were enrolled in the 2577 randomized clinical trials. Main outcome measures Redundant clinical trials were defined as randomized clinical trials that initiated or continued recruiting after 2008 (ie, one year after statin treatment was strongly recommended by clinical practice guidelines). The primary outcome is the number of extra MACEs that were attributable to the deprivation of statins among patients in the control groups of redundant clinical trials—that is, the number of extra MACEs that could have been prevented if patients were given statins. Cumulative meta-analyses were also conducted to establish the time points when statins were shown to have a statistically significant effect on coronary artery disease. Results 2045 redundant clinical trials were identified published between 2008 and 2019, comprising 101 486 patients in the control groups not treated with statins for 24 638 person years. 3470 (95% confidence interval 3230 to 3619) extra MACEs were reported, including 559 (95% confidence interval 506 to 612) deaths, 973 (95% confidence interval 897 to 1052) patients with new or recurrent myocardial infarction, 161 (132 to 190) patients with stroke, 83 (58 to 105) patients requiring revascularization, 398 (352 to 448) patients with heart failure, 1197 (1110 to 1282) patients with recurrent or deteriorated angina pectoris, and 99 (95% confidence interval 69 to 129) unspecified MACEs. Conclusions Of more than 2000 redundant clinical trials on statins in patients with coronary artery disease identified from mainland China, an extra 3000 MACEs, including nearly 600 deaths, were experienced by participants not treated with statins in these trials. The scale of redundancy necessitates urgent reform to protect patients.

Heart Rate Response to Exercise

2018 ◽  
pp. 437-445
Author(s):  
Gregory S. Thomas
Keyword(s):  
Heart Rate ◽  
Physical Fitness ◽  
Sample Size ◽  
Older Persons ◽  
Heart Rate Response ◽  
Large Sample Size ◽  
Maximum Heart Rate ◽  
Large Sample ◽  
Response To Exercise

The chapter Heart Rate Response to Exercise reviews the studies performed to estimate a patient’s maximum predicted heart rate. While the commonly used formula (220 – age), developed in 1971, is easy to remember, it underestimates the actual maximum heart rate in older persons. Studies of large sample size have found the maximum heart rate to be relatively independent of sex and physical fitness but to incrementally decline with age. The decrease with age is less than 1 beat per minute per year, however. A more accurate and recommended formula is [(208) – (0.7)(age)] as developed by Tanaka and colleagues.

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