scholarly journals Sequential Phase 1 and Phase 2 randomized, controlled trials of the safety, immunogenicity and efficacy of combined pre-erythrocytic vaccine antigens RTS,S and TRAP formulated with AS02 Adjuvant System in healthy, malaria naïve adults

Vaccine ◽  
2014 ◽  
Vol 32 (49) ◽  
pp. 6683-6691 ◽  
Author(s):  
Kent E. Kester ◽  
D. Gray Heppner ◽  
Philippe Moris ◽  
Opokua Ofori-Anyinam ◽  
Urszula Krzych ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Phase 1 ◽  
Controlled Trials ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Adjuvant System ◽  
Vaccine Antigens ◽  
Sequential Phase

Association of author’s financial conflict of interest with characteristics and outcome of rheumatoid arthritis randomized controlled trials

Rheumatology ◽  
2018 ◽  
Vol 58 (5) ◽  
pp. 776-785 ◽  
Author(s):  
Nasim Ahmed Khan ◽  
Chau L Nguyen ◽  
Talha Khawar ◽  
Horace Spencer ◽  
Karina D Torralba
Keyword(s):  
Drug Therapy ◽  
Randomized Controlled Trials ◽  
Conflicts Of Interest ◽  
Phase 1 ◽  
Temporal Trends ◽  
Positive Outcome ◽  
Stock Ownership ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Research Grant

Abstract Objective To examine the prevalence, types and temporal trends of reported financial conflicts of interest (FCOIs) among authors of drug therapy randomized controlled trials (RCTs) for RA and their association with study outcomes. Methods We identified original, non–phase 1, parallel-group, drug therapy RA RCTs published in the years 2002–03, 2006–07, and 2010–11. Two investigators independently obtained trial characteristics data. Authors’ FCOIs were classified as honoraria/consultation fees receipt, employee status, research grant, and stock ownership. Multivariable logistic regression was performed to identify whether FCOIs were independently associated with study outcome. Results A total of 146 eligible RCTs were identified. Of these, 83 (58.4%) RCTs had at least one author with an FCOI [employee status: 63 (43.2%), honoraria/consultation fees receipt: 49 (33.6%), research grant: 30 (20.5%), and stock ownership: 28 (19.2%)]. A remarkable temporal increase in reporting of honoraria/consultation fees receipt, research grant, and stock ownership was seen. The reporting of any FCOI itself was not associated with positive outcome [50/73 (68.5%) with author FCOI vs 36/52 (69.2%) without author FCOI, P = 0.93]. However, honoraria/consulting fees receipt was independently associated with increased likelihood of a positive outcome [adjusted odds ratio (95% CI) of 3.24 (1.06–9.88)]. In general, trials with FCOIs were significantly more likely to be multicentre, have larger enrolment, use biologic or a small molecule as the experimental intervention, and have better reporting of some methodological quality measures. Conclusion FCOI reporting in RA drug RCT authors is common and temporally increasing. Receipt of honoraria/consulting fees was independently associated with a positive study outcome.

scholarly journals MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials

2019 ◽  
Vol 236 (9) ◽  
pp. 2735-2745 ◽  
Author(s):  
Michael C. Mithoefer ◽  
Allison A. Feduccia ◽  
Lisa Jerome ◽  
Anne Mithoefer ◽  
Mark Wagner ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Study Design ◽  
Pooled Analysis ◽  
Controlled Trials ◽  
Phase 2 ◽  
Phase 3 ◽  
Randomized Controlled

The Sedative and Analgesic Sparing Effect of Music 

1998 ◽  
Vol 89 (2) ◽  
pp. 300-306 ◽  
Author(s):  
Marc E. Koch ◽  
Zeev N. Kain ◽  
Chakib Ayoub ◽  
Stanley H. Rosenbaum
Keyword(s):  
Phase 1 ◽  
Adverse Outcomes ◽  
Postanesthesia Care Unit ◽  
Control Group ◽  
Controlled Trials ◽  
Opioid Analgesia ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Duration Of Surgery ◽  
Sparing Effect

Background To determine whether music influences intraoperative sedative and analgesic requirements, two randomized controlled trials were performed. Methods In phase 1, 35 adults undergoing urologic procedures with spinal anesthesia and patient-controlled intravenous propofol sedation were randomly assigned to hear favorable intraoperative music via headset or to have no music. In phase 2, 43 adults undergoing lithotripsy treatment of renal or ureteral calculi and receiving patient-controlled intravenous opioid analgesia were randomly assigned to either a music or no-music group. The effect of music on sedatives and analgesics requirements, recovery room duration, and adverse outcomes was assessed. Results In phase 1, patients in the music group required significantly less propofol for sedation than patients in the control group (0 [0-150] mg vs. 90 [0-240] mg, median[range]; P < 0.001). These findings persisted after adjusting for duration of surgery (0.3+/-0.1 mg/min vs. 1.6+/-0.4 mg/min; P < 0.001). Similarly, in phase 2, patients who listened to music had a significant reduction in alfentanil requirements (1,600 [0-4,250] microg vs. 3,900 [0-7,200] microg; P = 0.005). This persisted after adjusting for duration of surgery (52+/-9 microg/min vs. 119 +/-16 microg/min, mean +/- SD, P < 0.001). Duration of stay in the postanesthesia care unit and the rate of adverse events was similar in both groups (P = NS). Conclusions Use of intraoperative music in awake patients decreases patient-controlled sedative and analgesic requirements. It should be noted, however, that patients in the no-music group did not use a headset during operation. Thus, the decrease in sedative and analgesic requirements could be caused by elimination of ambient operating room noise and not by the effects of music.

Efficacy outcomes in phase 2 and phase 3 randomized controlled trials in rheumatology

2020 ◽  
Vol 26 (6) ◽  
pp. 974-980 ◽  
Author(s):  
Andreas Kerschbaumer ◽  
Josef S. Smolen ◽  
Harald Herkner ◽  
Tijen Stefanova ◽  
Eva Chwala ◽  
...  
Keyword(s):  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Phase 2 ◽  
Phase 3 ◽  
Randomized Controlled

Reporting of Results by Sex in Randomized Controlled Trials of Acute Stroke Therapies (2010–2020)

Stroke ◽  
2021 ◽  
Author(s):  
Julia Pudar ◽  
Brent Strong ◽  
Virginia J. Howard ◽  
Mathew J. Reeves
Keyword(s):  
New England ◽  
Randomized Controlled Trials ◽  
Acute Stroke ◽  
Temporal Trends ◽  
Geographic Region ◽  
Controlled Trials ◽  
Phase 2 ◽  
Exact Test ◽  
Randomized Controlled ◽  
Trial Phase

Background and Purpose: When reporting primary results from randomized controlled trials, recommendations include reporting results by sex. We reviewed the reporting of results by sex in contemporary acute stroke randomized controlled trials. Methods: We searched MEDLINE for articles reporting the primary results of phase 2 or 3 stroke randomized controlled trials published between 2010 and June 2020 in one of nine major clinical journals. Eligible trials were restricted to those with a therapeutic intervention initiated within one month of stroke onset. Of primary interest was the reporting of results by sex for the primary outcome. We performed bivariate analyses using Fisher exact tests to identify study-level factors associated with reporting by sex and investigated temporal trends using an exact test for trend. Results: Of the 115 studies identified, primary results were reported by sex in 37% (n=42). Reporting varied significantly by journal, with the New England Journal of Medicine (61%) and Lancet journals (40%) having the highest rates ( P =0.03). Reporting also differed significantly by geographic region (21% Europe versus 48% Americas, P =0.03), trial phase (13% phase 2 versus 40% phase 3, P =0.05), and sample size (24% <250 participants versus 61% >750 participants, P <0.01). Although not statistically significant ( P =0.11), there was a temporal trend in favor of greater reporting among later publications (25% 2010–2012 versus 48% 2019–2020). Conclusions: Although reporting of primary trial results by sex improved from 2010 to 2020, the prevalence of reporting in major journals is still low. Further efforts are required to encourage journals and authors to comply with current reporting recommendations.

The Effect of Partly Missing Covariates on Statistical Power in Randomized Controlled Trials With Discrete-Time Survival Endpoints

Methodology ◽  
2017 ◽  
Vol 13 (2) ◽  
pp. 41-60
Author(s):  
Shahab Jolani ◽  
Maryam Safarkhani
Keyword(s):  
Randomized Controlled Trials ◽  
Discrete Time ◽  
Treatment Effect ◽  
Survival Data ◽  
Controlled Trials ◽  
Missing Covariates ◽  
Indicator Method ◽  
Imputation Methods ◽  
Randomized Controlled ◽  
Baseline Covariates

Abstract. In randomized controlled trials (RCTs), a common strategy to increase power to detect a treatment effect is adjustment for baseline covariates. However, adjustment with partly missing covariates, where complete cases are only used, is inefficient. We consider different alternatives in trials with discrete-time survival data, where subjects are measured in discrete-time intervals while they may experience an event at any point in time. The results of a Monte Carlo simulation study, as well as a case study of randomized trials in smokers with attention deficit hyperactivity disorder (ADHD), indicated that single and multiple imputation methods outperform the other methods and increase precision in estimating the treatment effect. Missing indicator method, which uses a dummy variable in the statistical model to indicate whether the value for that variable is missing and sets the same value to all missing values, is comparable to imputation methods. Nevertheless, the power level to detect the treatment effect based on missing indicator method is marginally lower than the imputation methods, particularly when the missingness depends on the outcome. In conclusion, it appears that imputation of partly missing (baseline) covariates should be preferred in the analysis of discrete-time survival data.

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