Review of Clinical Equipoise: Examples from Oncology Trials

2021 ◽  
Vol 17 ◽  
Author(s):  
Majd A. Hamaly ◽  
Karem H. Alzoubi ◽  
Omar F. Khabour ◽  
Ruba A. Jaber ◽  
Wael Al-delaimy
Keyword(s):  
Clinical Trials ◽  
Anticancer Agents ◽  
Human Subjects ◽  
Specific Reference ◽  
Clinical Equipoise ◽  
Equal Distribution ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
Oncology Clinical Trials ◽  
The Status

Background: The current standards that govern clinical research have been shaped over the years through many historical, social, and political events. The third principle of the Belmont report, Justice, guides the scientific community toward equal distribution of benefits and risks in research involving human subjects. Clinical equipoise is the status of genuine uncertainty by the investigator about the superiority of one treatment arm over the other. The term clinical equipoise was proposed to provide an ethical ground to conduct randomized controlled clinical trials. Objective: The objective of this review is to provide the reader with an overview about the emergence of the term equipoise and its utilization in randomized controlled trials. Methods: In the current review article, the major oncology clinical trials and relevant patents were reviewed for the application/utilization of clinical equipoise. Results: The concept of clinical equipoise has been challenged and different alternatives were proposed. Yet, these alternatives received numerous critiques and failed to fully replace equipoise. In addition, several patents related to anticancer agents tested in the described studies were examined. No specific reference was made as part of the patent to the status of clinical equipoise. Alternatively, a description of the study arms was provided. Conclusion: There is a need for revisiting the concept of equipoise and its suggested alternatives, for its ethical essence while addressing related challenges.

L-arginine effect on inflammatory mediators: A systematic review of randomized controlled clinical trials

2019 ◽  
pp. 1-9 ◽  
Author(s):  
Seyed Reza Mirhafez ◽  
Mitra Hariri
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Inflammatory Mediators ◽  
Randomized Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Patients With Cancer ◽  
Reactive Protein ◽  
Randomized Controlled ◽  
Human Adults ◽  
Factor Α

Abstract. L-arginine is an important factor in several physiological and biochemical processes. Recently, scientists studied L-arginine effect on inflammatory mediators such as C-reactive protein (CRP), tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6). We conducted a systematic review on randomized controlled trials assessing L-arginine effect on inflammatory mediators. We searched data bases including Google scholar, ISI web of science, SCOPUS, and PubMed/Medline up to April 2019. Randomized clinical trials assessing the effect of L-arginine on inflammatory mediators in human adults were included. Our search retrieved eleven articles with 387 participants. Five articles were on patients with cancer and 6 articles were on adults without cancer. L-arginine was applied in enteral form in 5 articles and in oral form in 6 articles. Eight articles were on both genders, two articles were on women, and one article was on men. L-arginine could not reduce inflammatory mediators among patients with and without cancer except one article which indicated that taking L-arginine for 6 months decreased IL-6 among cardiopathic nondiabetic patients. Our results indicated that L-arginine might not be able to reduce selected inflammatory mediators, but for making a firm decision more studies are needed to be conducted with longer intervention duration, separately on male and female and with different doses of L-arginine.

scholarly journals Long-Term Dietary and Physical Activity Interventions in the School Setting and Their Effects on BMI in Children Aged 6–12 Years: Meta-Analysis of Randomized Controlled Clinical Trials

Healthcare ◽  
2021 ◽  
Vol 9 (4) ◽  
pp. 396
Author(s):  
Purificación Cerrato-Carretero ◽  
Raúl Roncero-Martín ◽  
Juan D. Pedrera-Zamorano ◽  
Fidel López-Espuela ◽  
Luis M. Puerto-Parejo ◽  
...  
Keyword(s):  
Physical Activity ◽  
Clinical Trials ◽  
Dietary Habits ◽  
Meta Analysis ◽  
Controlled Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled ◽  
School Based ◽  
School Based Interventions

Preventive actions and potential obesity interventions for children are mainly researched throughout the school period, either as part of the school curricula or after regular school hours, via interventions mostly lasting less than 12 months. We aimed to perform a meta-analysis on randomized controlled clinical trials to evaluate the evidence of the efficacy of long-term school-based interventions in the management of childhood obesity in terms of BMI from a dietary and physical activity-based approach. Eleven randomized controlled clinical trials were examined using the random effects model, and the results showed that there were no significant effects associated with physical activity + nutrition intervention in school children aged 6–12 years, with a pooled standardized mean difference (SMD) (95% CI) of −0.00 (−0.05, 0.04). No effects were observed after subgroup analysis based on the intervention length. The findings from our study indicate that long-term school-based interventions on physical activity and dietary habits received by children aged 6–12 years seem to have no effect on BMI. However, the promotion of such interventions should not be discouraged, as they promote additional positive health outcomes for other domains of children’s health.

Coffee Consumption and Serum Lipids: A Meta-Analysis of Randomized Controlled Clinical Trials

2001 ◽  
Vol 153 (4) ◽  
pp. 353-362 ◽  
Author(s):  
Sun Ha Jee ◽  
Jiang He ◽  
Lawrence J. Appel ◽  
Paul K. Whelton ◽  
II Suh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Serum Lipids ◽  
Meta Analysis ◽  
Coffee Consumption ◽  
Controlled Clinical Trials ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

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