FRI0380 ITEMS DRIVING WOMAC PAIN SUBSCORE CHANGES DUE TO LORECIVIVINT, A POTENTIAL DISEASE-MODIFYING TREATMENT FOR KNEE OSTEOARTHRITIS: A POST HOC ANALYSIS OF PHASE 2B TRIAL DATA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 787-788
Author(s):  
S. Kennedy ◽  
C. Swearingen ◽  
I. Simsek ◽  
J. Tambiah
Keyword(s):  
Effect Size ◽  
Target Population ◽  
Effect Sizes ◽  
Primary Study ◽  
Womac Pain ◽  
Widespread Pain ◽  
Post Hoc Analysis ◽  
Knee Oa ◽  
Post Hoc ◽  
Disease Modifying Treatment

Background:Knee osteoarthritis (OA) is a disease characterized by pain, loss of function, and structural deformities, leading to a heterogeneous disease state that can confound patient-reported outcomes (PROs). The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscore addresses this reporting variability by capturing multiple pain items related to ‘active’ and ‘static’ subject states. We hypothesize that measurement of these ‘active’ versus ‘static’ pain items may demonstrate differential effect sizes when assessing treatment benefit. Lorecivivint (LOR; SM04690), a small-molecule, intra-articular CLK/DYRK1A inhibitor that modulates the Wnt pathway, is currently in development as a potential disease-modifying treatment for knee OA.1,2Objectives:To test the hypothesis, a post hoc analysis of Pain NRS, the WOMAC Pain subscore, and individual WOMAC PROs (items A1–A5) from a Phase 2b LOR trial was performed to examine effect size (ES) changes.Methods:The original 24-week Phase 2b trial has been previously reported. In this study, pain was assessed using the weekly average of daily Pain NRS and WOMAC Pain subscore. In the post hoc analysis, items A1–A5 (pain walking on a flat surface? [A1], going up/downstairs? [A2], at night in bed? [A3], sitting or lying down? [A4], and while standing? [A5]) were individually analyzed for subjects treated with 0.07 mg LOR and compared with the primary study outcomes of mean Pain NRS and summed mean WOMAC Pain subscore at Week 12. Baseline-adjusted analysis of covariance for WOMAC A1–A5 scores was conducted on LOR-treated subjects compared with placebo (PBO) in 1) the Full Analysis Set (FAS) of all dosed subjects and 2) a target population of subjects with fixed baseline joint space width (JSW) [2–4] mm without widespread pain (Widespread Pain Index [WPI] ≤4, Symptom Severity Score Question 2≤2).Results:In this analysis, 231 subjects (KL grade 3 63.2%) were included. The primary study analysis demonstrated efficacy of LOR compared with PBO for Pain NRS and WOMAC Pain, with respective effect sizes of 0.450 and 0.293 (Figure). In the target population, Pain NRS and WOMAC A effect sizes increased (0.637 and 0.410, respectively). Each WOMAC A item showed less of an effect size than Pain NRS at Week 12. Treatment with 0.07 mg LOR compared with PBO showed significant improvements in effect sizes of WOMAC A1 (FAS: ES=0.315,P=0.028; target population: ES=0.421,P=0.035) and A2 (FAS: ES=0.392,P=0.006; target population: ES=0.510,P=0.011). A3–A5 did not show statistical improvement for LOR compared with PBO.Figure.Effect sizes for 0.07 mg LOR compared with PBO for the FAS and target population at Week 12.Conclusion:In the post hoc analysis, Pain NRS exhibited the greatest effect size of tested PROs after treatment with 0.07 mg LOR compared with PBO. These effect sizes were enhanced in the target population with fixed baseline JSW and without widespread pain for all scores relative to the FAS. WOMAC ‘active’ questions demonstrated greater effect sizes with LOR treatment than ‘static’ questions and the full WOMAC Pain domain, providing support for the hypothesized dimensional constructs in knee OA pain assessment.References:[1]Deshmukh V, et al.Osteoarthritis Cartilage. 2017.[2]Deshmukh V, et al.Osteoarthritis Cartilage. 2019.Disclosure of Interests:Sarah Kennedy Shareholder of: Samumed, LLC, Employee of: Samumed, LLC, Christopher Swearingen Shareholder of: Samumed, LLC, Employee of: Samumed, LLC, Ismail Simsek Shareholder of: Samumed, LLC, Employee of: Samumed, LLC, Jeyanesh Tambiah Shareholder of: Samumed, LLC, Employee of: Samumed, LLC

scholarly journals FRI0430 THE NOVEL, INTRA-ARTICULAR CLK/DYRK1A INHIBITOR LORECIVIVINT (LOR; SM04690), WHICH MODULATES THE WNT PATHWAY, IMPROVED RESPONDER OUTCOMES IN SUBJECTS WITH KNEE OSTEOARTHRITIS: A POST HOC ANALYSIS FROM A PHASE 2B TRIAL

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 813.2-814
Author(s):  
Y. Yazici ◽  
S. Kennedy ◽  
C. Swearingen ◽  
J. Tambiah
Keyword(s):  
Wnt Pathway ◽  
Rating Scale ◽  
Womac Pain ◽  
Phase 3 ◽  
Post Hoc Analysis ◽  
Threshold Response ◽  
Knee Oa ◽  
Womac Function ◽  
Patient Reported ◽  
Post Hoc

Background:Lorecivivint (LOR; SM04690) is a small-molecule, intra-articular (IA) CLK/DYRK1A inhibitor that modulates the Wnt pathway1and has demonstrated some beneficial effects on patient-reported outcomes (PROs) relative to placebo (PBO) in two Phase 2 knee OA trials. With subjective measures such as PROs, meaningful benefits may be better characterized by representation as discrete threshold responses rather than by changes in mean point estimates.Objectives:To conduct a post hoc analysis of subjects in a 24-week Phase 2b study by measuring the proportions of subjects treated with LOR and placebo (PBO) who achieved 30%, 50%, or 70% threshold responses of improvement over baseline in Pain Numeric Rating Scale (NRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain, WOMAC Function, and Patient Global Assessment (PtGA) at Week 12. Results from the Phase 3-selected dose of 0.07 mg LOR are presented here.Methods:Subjects had ACR-defined knee OA, Kellgren-Lawrence (KL) grades 2–3, and Pain NRS scores ≥4 and ≤8 in the target knee and <4 in the contralateral knee. A single 2mL IA injection of 0.03 mg, 0.07 mg, 0.15 mg, or 0.23 mg LOR, or vehicle PBO was given in the target knee at baseline. The proportion of subjects meeting 30%, 50%, or 70% threshold responses over baseline in the weekly average of daily Pain NRS [0–10], WOMAC Pain [0–100], WOMAC Function [0–100], and PtGA [0–100] at Week 12 was determined. The odds ratios (OR [95% CI]) of achieving each threshold response level were calculated and compared between LOR and PBO.Results:In total, 635 subjects (91.4%) completed the study (mean age 59.0±8.5 years, BMI 29.0±4.0 kg/m2, female 58.4%, KL grade 3 57.3%). At Week 12, treatment with 0.07 mg LOR significantly (P<0.05) increased the odds of a 30% threshold response in Pain NRS (OR 2.47 [1.45, 4.19]) and WOMAC Function (OR 1.86 [1.10, 3.12]) and a 50% threshold response in WOMAC Pain (OR 1.79 [1.06, 3.03]) and PtGA (OR 2.28 [1.25, 4.16]). Numerically, more (not statistically significant) subjects achieved a 70% threshold response in all PROs. All improvements were maintained through Week 24.Conclusion:In this post hoc analysis, LOR-treated subjects reported greater improvements in PRO threshold responses versus PBO from Week 12 through Week 24. LOR demonstrated significantly higher odds of achieving and maintaining improvements in PROs at 30% and 50% thresholds. Phase 3 studies of 0.07 mg LOR are ongoing.References:[1]Deshmukh V, et al.Osteoarthr Cartil. 2019.Disclosure of Interests:Yusuf Yazici Shareholder of: Samumed, LLC, Grant/research support from: Bristol-Myers Squibb, Celgene, and Genentech, Consultant of: Celgene and Sanofi, Employee of: Samumed, LLC, Sarah Kennedy Shareholder of: Samumed, LLC, Employee of: Samumed, LLC, Christopher Swearingen Shareholder of: Samumed, LLC, Employee of: Samumed, LLC, Jeyanesh Tambiah Shareholder of: Samumed, LLC, Employee of: Samumed, LLC

Exploring the Morning Morality Effect in the context of moral utilitarianism: a post-hoc analysis

2021 ◽  
Author(s):  
Bastien Trémolière ◽  
Corentin J Gosling
Keyword(s):  
Effect Size ◽  
Autonomous Vehicles ◽  
Meta Analysis ◽  
Individual Study ◽  
Post Hoc Analysis ◽  
Cognitive Reflection ◽  
Confounding Variables ◽  
Small Effect Size ◽  
Large Heterogeneity ◽  
Post Hoc

Recent research has shown mixed evidence for the morning morality effect (i.e., the observation that individuals are less immoral in the morning than in the afternoon). In the present research, we target the morning morality effect in the context of moral utilitarianism, by reanalyzing observational data previously collected by our lab. These data include different tasks capturing moral utilitarianism (i.e., standard sacrificial dilemmas, an ecological utilitarian scale, and/or dilemmas involving the morality of autonomous vehicles). We report a meta-analysis of 6 studies which showed that participants became less utilitarian as the day goes on, but with a small effect size (r = -0.14) and a large heterogeneity. Exploration of this heterogeneity showed that such a conclusion was statistically significant for classic sacrificial dilemmas only. Notably, even when restricting the analysis to the classic sacrificial dilemmas, a moderate inconsistency remained. Post-hoc analysis of an individual study showed that this small effect did not survive the inclusion of potentially confounding variables, such as psychopathy trait and cognitive reflection. Implications and limitations are discussed.

scholarly journals Is there sufficient scientific evidence to rule out the use of hydroxychloroquine for postexposure prophylaxis of COVID-19?

2020 ◽  
Author(s):  
Llorenç Quintó ◽  
Jose Miguel Morales-Asencio ◽  
Raquel González ◽  
Clara Menéndez
Keyword(s):  
Public Health ◽  
Effect Size ◽  
Statistical Power ◽  
Scientific Evidence ◽  
Post Exposure Prophylaxis ◽  
Postexposure Prophylaxis ◽  
Post Hoc Analysis ◽  
Exposure Prophylaxis ◽  
Post Hoc ◽  
Rule Out

Since the beginning of the COVID-19 pandemic, the use of hydroxychloroquine (HCQ) has been surrounded by a lot of controversy, both scientific and non-scientific. This has continued with the publication of two trials of HCQ for post-exposure prophylaxis of the infection, which concluded that HCQ is not efficacious to prevent SARS-CoV-2 infection, and their results are influencing public health decisions.We have carried out a comprehensive post-hoc analysis of the statistical power of the two trials, which shows that their power to detect an effect of HCQ in preventing COVID-19 is low, not only for their observed effect size, but also for other clinically important levels of efficacy, and therefore both studies are inconclusive.

scholarly journals Averaging Dependent Effect Sizes in Meta-Analysis: a Cautionary Note about Procedures

1999 ◽  
Vol 2 ◽  
pp. 32-38 ◽  
Author(s):  
Fulgencio Marín-Martínez ◽  
Julio Sánchez-Meca
Keyword(s):  
Effect Size ◽  
Meta Analysis ◽  
Arithmetic Mean ◽  
Effect Sizes ◽  
Primary Study ◽  
Simple Arithmetic ◽  
Dependent Effect ◽  
Multiple Effect ◽  
Dependent Effect Sizes ◽  
Selection Of

When a primary study includes several indicators of the same construct, the usual strategy to meta-analytically integrate the multiple effect sizes is to average them within the study. In this paper, the numerical and conceptual differences among three procedures for averaging dependent effect sizes are shown. The procedures are the simple arithmetic mean, the Hedges and Olkin (1985) procedure, and the Rosenthal and Rubin (1986) procedure. Whereas the simple arithmetic mean ignores the dependence among effect sizes, both the procedures by Hedges and Olkin and Rosenthal and Rubin take into account the correlational structure of the effect sizes, although in a different way. Rosenthal and Rubin's procedure provides the effect size for a single composite variable made up of the multiple effect sizes, whereas Hedges and Olkin's procedure presents an effect size estimate of the standard variable. The three procedures were applied to 54 conditions, where the magnitude and homogeneity of both effect sizes and correlation matrix among effect sizes were manipulated. Rosenthal and Rubin's procedure showed the highest estimates, followed by the simple mean, and the Hedges and Olkin procedure, this last having the lowest estimates. These differences are not trivial in a meta-analysis, where the aims must guide the selection of one of the procedures.

scholarly journals Beta-Alanine Supplementation and Sport Climbing Performance

2021 ◽  
Vol 18 (10) ◽  
pp. 5370
Author(s):  
Krzysztof Sas-Nowosielski ◽  
Judyta Wyciślik ◽  
Piotr Kaczka
Keyword(s):  
Effect Sizes ◽  
Upper Body ◽  
Time To Failure ◽  
Improve Performance ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Beta Alanine ◽  
Sport Climbing ◽  
Specific Performance ◽  
Post Hoc

Background: Supplementing β-alanine (BA) improves exercise performance in efforts that are highly dependent on anaerobic glycolysis. As it has not yet been established whether it relates to climbing, the current study aimed to investigate the effects of BA on climbing-specific performance. Methods: Fifteen elite climbers performed intermittent high-force high-velocity campus board exercise, and two bouldering traverses, hard and easy. They ingested 4.0 g·d−1 BA or placebo for four weeks in a double-blind, pre/post experimental design. Results: In the campus board trial, ANOVA revealed a tendency toward significance (p = 0.066). Post hoc analysis revealed that there was a significant (p = 0.002) and “large” (d = 1.55) increase in the total number of “slaps” in the BA group. No significant supplementation × group interaction was found in “hard” traverse and a significant interaction for mean changes in number of moves (p = 0.025) and in time to failure (p = 0.044) on an “easy” traverse. Post hoc analysis revealed that only the BA group significantly improved from baseline in number of moves (+9.5) and time to failure (+32 s). Effect sizes were d = 1.73 and d = 1.44, respectively. Conclusions: Four weeks of BA supplementation can improve performance during continuous climbing lasting about 1 min and repeated bouts of upper body campus-like movements. However, it failed to enhance climbing of a shorter duration.

scholarly journals Efficacy of Lurasidone in Antipsychotic-Naive vs. Antipsychotic-Exposed Adolescents with Schizophrenia: Post-Hoc Analysis of a Two-Year, Open-Label Study

CNS Spectrums ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 147-147
Author(s):  
Christoph Correll ◽  
Michael Tocco ◽  
Andrei Pikalov ◽  
Jay Hsu ◽  
Robert Goldman
Keyword(s):  
Effect Size ◽  
Extension Phase ◽  
Controlled Study ◽  
Open Label ◽  
Antipsychotic Therapy ◽  
Post Hoc Analysis ◽  
Long Term Treatment ◽  
Treatment Naïve ◽  
Post Hoc

AbstractBackgroundFew studies have examined treatment response in adolescents with schizophrenia who are treatment-naive; and there is no placebo-controlled study that we are aware of in first episode treatment-naive patients with schizophrenia. The aim of this analysis was to evaluate the long-term efficacy of lurasidone in antipsychotic-naive adolescents with schizophrenia.MethodPatients aged 13–17 years with schizophrenia, and a PANSS total score ≥70 and <120, were randomized to 6 weeks of double-blind (DB) treatment with lurasidone (40 or 80 mg/day) or placebo. Six-week completers were eligible to enroll in a 2-year open-label extension phase receiving lurasidone flexibly dosed from 20–80 mg/day. In a post-hoc analysis, efficacy was evaluated for 2 patient groups based on treatment status prior to entering the initial 6-week DB study (treatment naïve [TN] vs. treated previously [TP]). Treatment-naïve was defined as never having received antipsychotic treatment. Efficacy measures included the PANSS total score and the Clinical Global Impression, Severity (CGI-S) score. Level of functioning was assessed using the Children’s Global Assessment Scale (CGAS), with a score of 70 representing normative levels of functioning.ResultsA total of 50 TN and 221 TP patients completed the 6-week DB study and entered the extension study; and 30 (60.0%) TN and 126 (57.0%) TP patients completed 104 weeks. During the initial 6 weeks of DB treatment, mean change in PANSS total score at endpoint was greater for lurasidone vs. placebo in both the TN group (−25.0 vs. −14.4; P<0.02; effect size, 0.75), and in the TP group (−17.3 vs. −10.0; P<0.001; effect size, 0.45). During OL extension phase treatment with lurasidone, mean change from DB baseline in the PANSS total score for TN and TP patients, at week 52 was −32.6 (n=38) and −28.1 (n=151), respectively; and at week 104 was −33.6 (n=30) and −29.2 (n=126), respectively. Mean change from DB baseline in CGI-S score at both weeks 52 and 104 was −1.8 for TN patients and −1.5 for TP patients. At DB baseline mean CGAS scores indicated significant functional impairment in both the TN and TP patients (CGAS=48 and 43, respectively). During OL treatment with lurasidone, mean change (from DB baseline) in the CGAS score at Weeks 52 and 104, respectively, was +22.0 and +22.9 in TN patients, and +21.1 and +22.9 in TP patients. During OL treatment with lurasidone, mean observed change from DB baseline in the weight (in kg,) at Weeks 52 and 104, respectively, was +4.2 and +4.8 in TN patients, and +4.0 and +5.0 in TP patients. These weight increases are consistent with expected weight gains in adolescents during a 2-year period (based on CDC growth charts).ConclusionsIn this post-hoc analysis of a 2-year study, adolescents with schizophrenia who had received no previous antipsychotic therapy showed greater improvement compared to previously treated patients during both short- and long-term treatment with lurasidone.FundingSunovion Pharmaceuticals Inc.

scholarly journals AB0856 A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED, TRIAL OF AMZ001 – A NOVEL DICLOFENAC SODIUM 3.06% GEL - FOR THE TREATMENT OF KNEE OSTEOARTHRITIS SYMPTOMS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1735.1-1736
Author(s):  
A. Bihlet ◽  
I. Byrjalsen ◽  
H. B. Nielsen ◽  
J. Andersen ◽  
L. Delpy ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Randomized Trial ◽  
Diclofenac Sodium ◽  
Application Site ◽  
Womac Pain ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Knee Oa ◽  
Post Hoc

Background:Development of improved topical treatments of painful joints is warranted. A novel diclofenac sodium gel formulation, AMZ001, has been developed with the purpose of improving 1) The onset and duration of pain relief, and 2) The ease of use by reducing the required daily frequency of gel application. Previous trials in human subjects have confirmed improved permeability of a reduced volume of AMZ001 gel as compared to approved diclofenac topical products with a comparable safety and tolerability profile, supporting trials to evaluate the efficacy and safety of AMZ001 in painful joint conditions.Objectives:The current abstract reports the main results of a randomized trial of AMZ001 once or twice daily application versus placebo in symptomatic knee osteoarthritis.Methods:The trial was a placebo-controlled, parallel group, double-blind, randomized trial to evaluate the efficacy and safety of AMZ001 or placebo in subjects with knee osteoarthritis. The main inclusion criteria were Kellgren-Lawrence radiographic severity of 1-3, and pain ≥40 and ≤90 out of 100 using the WOMAC pain subscale (5 questions) at the time of screening. The subjects were randomized to apply AMZ001 gel once (QD) or twice (BID) daily or placebo twice daily per OA knee for a period of 28 days, or to apply Voltaren® Gel 1 % four times daily (QID) in a single-blind fashion for exploratory comparison. The primary endpoint was change from baseline at week 4 in WOMAC pain (5 questions). The main secondary endpoints included WOMAC subscales, Patient Global Assessment (PGA) and quality of life using the EQ-5D. In addition to the main analysis, a post-hoc subgroup analysis of subjects meeting the pain criterion at both screening and baseline was performed.Results:A total of 444 subjects were randomized. The main baseline characteristics were well balanced between treatment groups.AMZ001 QD and BID led to statistically significant reductions in pain compared to baseline with an estimated difference (95% CI) normalized to 0-100 at week 4 of -27.33 (-30.50, -24.17), and -26.49 (-29.60, -23.38), respectively. Reduction in pain at week 4 was statistically significantly superior to placebo for AMZ001 QD (p=0.04), and borderline significant for AMZ001 BID (p<0.10) as shown in Figure 1.Both AMZ001 QD and BID led to statistically significant improvements in PGA at week 4 compared to placebo (p<0.05 for both), and AMZ001 BID led to significantly improved quality of life (p<0.05) compared to placebo. There were no statistically significant differences between AMZ001 QD or BID in any of the endpoints. In the post-hoc analysis of subjects meeting the pain criterion at both screening and baseline the differentiation to placebo was strengthened for all efficacy endpoints, as shown in Figure 2.While the study design and differences in sample sizes does not allow formal comparisons between the double- and single blinded groups, the exploratory comparator, Voltaren QID, did not reach statistically significant differences to placebo or AMZ001 in any of the endpoints, in neither the ITT nor the subgroup analyses.The safety and tolerability of AMZ001 was favorable, as the frequency of AEs leading to discontinuation of treatment was similarly low (ranging between 2.8 % to 6.6 %) between AMZ001 once or twice daily and placebo or Voltaren Gel 1%. The most common treatment-emergent AEs were application site dryness, and application site erythema. No serious adverse events were reported during the trial.Conclusion:AMZ001, a novel topical diclofenac formulation, either once or twice daily was efficacious in the treatment of knee OA pain with a good tolerability and safety profile, suggesting AMZ001 may be a promising alternative to existing pain-relieving treatments in knee OA.References:NADisclosure of Interests:Asger Bihlet Shareholder of: Nordic Bioscience, Consultant of: Amzell BV, Medivir AB, Xintela AB, Merck KGaA, Employee of: Nordic Bioscience, Inger Byrjalsen Employee of: Nordic Bioscience, Henning Bay Nielsen: None declared, Jeppe Andersen Shareholder of: Minor shareholder of Nordic Bioscience, Consultant of: Medivir AB, Xintela AB, Employee of: Nordic Bioscience, Laetitia Delpy Employee of: Amzell BV, Caroline Derne Employee of: Amzell BV, Dario Carrara Employee of: Amzell BV

Statistical Power of Negative Randomized Controlled Trials Presented at American Society for Clinical Oncology Annual Meetings

2007 ◽  
Vol 25 (23) ◽  
pp. 3482-3487 ◽  
Author(s):  
Philippe L. Bedard ◽  
Monika K. Krzyzanowska ◽  
Melania Pintilie ◽  
Ian F. Tannock
Keyword(s):  
Sample Size ◽  
Effect Size ◽  
Statistical Power ◽  
Effect Sizes ◽  
Controlled Trials ◽  
Time To Event ◽  
Randomized Controlled ◽  
American Society ◽  
Post Hoc ◽  
Adequate Sample Size

Purpose To investigate the prevalence of underpowered randomized controlled trials (RCTs) presented at American Society of Clinical Oncology (ASCO) annual meetings. Methods We surveyed all two-arm phase III RCTs presented at ASCO annual meetings from 1995 to 2003 for which negative results were obtained. Post hoc calculations were performed using a power of 80% and an α level of .05 (two sided) to determine sample sizes required to detect small, medium, and large effect sizes. For studies reporting a proportion or time-to-event as primary end point, effect size was expressed as an odds ratio (OR) or hazard ratio (HR), respectively, with a small effect size defined as OR/HR ≥ 1.3, medium effect size defined as OR/HR ≥ 1.5, and large effect size defined as OR/HR ≥ 2.0. Logistic regression was used to identify factors associated with lack of statistical power. Results Of 423 negative RCTs for which post hoc sample size calculations could be performed, 45 (10.6%), 138 (32.6%), and 233 (55.1%) had adequate sample size to detect small, medium, and large effect sizes, respectively. Only 35 negative RCTs (7.1%) reported a reason for inadequate sample size. In a multivariable model, studies that were presented at oral sessions (P = .0038), multicenter studies supported by a cooperative group (P < .0001), and studies with time to event as primary outcome (P < .0001) were more likely to have adequate sample size. Conclusion More than half of negative RCTs presented at ASCO annual meetings do not have an adequate sample to detect a medium-size treatment effect.

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