Search results for: Jitendra Ganju

Items from 1 to 18 out of 18 results

article

Sample size formula for a win ratio endpoint

Ron Xiaolong Yu, Jitendra Ganju

Statistics in Medicine > 41 > 14 > 2691 - 2692

article

Sample size formula for a win ratio endpoint

Ron Xiaolong Yu, Jitendra Ganju

Statistics in Medicine > 41 > 6 > 950 - 963

The win ratio composite endpoint, which organizes the components of the composite hierarchically, is becoming popular in late‐stage clinical trials. The method involves comparing data in a pair‐wise manner starting with the endpoint highest in priority (eg, cardiovascular death). If the comparison is a tie, the endpoint next highest in priority (eg, hospitalizations for heart failure) is compared,...

article

Non-inferiority versus superiority drug claims: the (not so) subtle distinction

Jitendra Ganju, Dror Rom

Trials > 2017 > 18 > 1 > 1-5

Background Current regulatory guidance and practice of non-inferiority trials are asymmetric in favor of the test treatment (Test) over the reference treatment (Control). These trials are designed to compare the relative efficacy of Test to Control by reference to a clinically important margin, M. Main text Non-inferiority trials allow for the conclusion of: (a) non-inferiority of Test to Control...

article

Robust inference for group sequential trials

Jitendra Ganju, Yunzhi Lin, Kefei Zhou

Pharmaceutical Statistics > 16 > 2 > 167 - 173

For ethical reasons, group sequential trials were introduced to allow trials to stop early in the event of extreme results. Endpoints in such trials are usually mortality or irreversible morbidity. For a given endpoint, the norm is to use a single test statistic and to use that same statistic for each analysis. This approach is risky because the test statistic has to be specified before the study...

article

Robust inference from multiple test statistics via permutations: a better alternative to the single test statistics approach for randomized trials

Jitendra Ganju, Xinxin Yu, Guoguang (Julie) Ma

Pharmaceutical Statistics > 15 > 2 > 193 - 193

article

Variation in Liver Biochemistries in Patients with Decompensated Cirrhosis: Implications for Assessing Drug-Induced Liver Injury in Clinical Trials

Marzena Jurek, Masoud Mokhtarani, John M. Vierling, Dion F. Coakley, more

Pharmaceutical Medicine > 2016 > 30 > 2 > 95-101

Background Current approaches to detection of drug-induced liver injury (DILI) are generally based on changes from normal in biochemical liver tests. However, limited information is available regarding the proportion of patients with normal versus abnormal biochemical tests, the expected temporal pattern of biochemical abnormalities, or the applicability of current approaches to DILI detection for...

article

Improving the operational efficiency of Phase 2 and 3 trials

Jitendra Ganju

Trials > 2016 > 17 > 1 > 1-3

The period toward the end of patients’ participation in late stage blinded clinical trials is highly resource intensive for the sponsor. Consider first a Phase 3 trial. If the trial is a success, the sponsor has to implement the next steps, which might be filing for approval of the drug with the US Food and Drug Administration (FDA). To shorten the time interval between trial completion and submission...

article

Response to ‘Inclusion of Placebos and Blinding for Ascending Dose First‐in‐Human Studies and Other Underpowered Phase 1 studies has not been Justified and on Balance is Not Useful’ by D.A. Parasrampuria and L.Z. Benet

Jitendra Ganju, Clapton Dias

Basic & Clinical Pharmacology & Toxicology > 117 > 6 > 365 - 366

article

Robust inference from multiple test statistics via permutations: a better alternative to the single test statistic approach for randomized trials

Jitendra Ganju, Xinxin Yu, Guoguang (Julie) Ma

Pharmaceutical Statistics > 12 > 5 > 282 - 290

Formal inference in randomized clinical trials is based on controlling the type I error rate associated with a single pre‐specified statistic. The deficiency of using just one method of analysis is that it depends on assumptions that may not be met. For robust inference, we propose pre‐specifying multiple test statistics and relying on the minimum p‐value for testing the null hypothesis of no treatment...

article

Comments on ‘Sample size for equivalence trials: a case study from a vaccine lot consistency trial’

Jitendra Ganju, Allen Izu

Statistics in Medicine > 31 > 15 > 1654 - 1654

article

The benefit of stratification in clinical trials revisited

Jitendra Ganju, Kefei Zhou

Statistics in Medicine > 30 > 24 > 2881 - 2889

Stratification is common in clinical trials because it can reduce the variance of the estimated treatment effect. The traditional demonstration of variance reduction relies on the assumption of stratum sizes being fixed quantities. However, in practice, to speed up enrollment, and to obtain a study population with a similar distribution as the overall population, the stratum sizes are allowed to vary...

article

Strengthening the understanding of the relationship between survival designs and test statistics

Guoguang Ma, Jitendra Ganju

Pharmaceutical Statistics > 9 > 2 > 113 - 124

In the planning of randomized survival trials, the role of follow‐up time of trial participants introduces a level of complexity not encountered in non‐survival trials. Of the two commonly used survival designs, one design fixes the follow‐up time whereas the other allows it to vary. When the follow‐up time is fixed the number of events varies. Conversely, when the number of events is fixed, the follow‐up...

article

Safety and Immunogenicity of an Intramuscular Helicobacter pylori Vaccine in Noninfected Volunteers: A Phase I Study

Peter Malfertheiner, Viola Schultze, Bernd Rosenkranz, Stefan H.E. Kaufmann, more

Gastroenterology > 2008 > 135 > 3 > 787-795

Introduction: Helicobacter pylori infection is among the most common human infections and the major risk factor for peptic disease and gastric cancer. Immunization with vaccines containing the H pylori vacuolating cytotoxin A (VacA), cytotoxin-associated antigen (CagA), and neutrophil-activating protein (NAP), alone or in combination, have been shown to prevent experimental infection in animals. Aim:...

article

Randomized and random run order experiments

Jitendra Ganju, James M. Lucas

Journal of Statistical Planning and Inference > 2005 > 133 > 1 > 199-210

Randomization in industrial and scientific experiments on equipment has meant randomizing the order of application of levels of treatments to units. This definition is inadequate because it does not render independent error terms. Randomization also requires independent resettings of treatment levels when the levels for the preceding run are the same. We review how the literature incorrectly explains...

article

Stratified experiments reexamined with emphasis on multicenter trials

Jitendra Ganju, Devan V. Mehrotra

Controlled Clinical Trials > 2003 > 24 > 2 > 167-181

In many stratified experiments the researcher fixes the total sample size but either cannot or does not exert control over the sample size per stratum. A classic example is a randomized, two-treatment, multicenter clinical trial-the total sample sizes per treatment group are fixed by design but the sample sizes per center are allowed to vary. Standard analyses of continuous data from such trials fail...

article

On choosing between fixed and random block effects in some no-interaction models

Jitendra Ganju

Journal of Statistical Planning and Inference > 2000 > 90 > 2 > 323-334

The purpose of this article is to strengthen the understanding of the relationship between a fixed-blocks and random-blocks analysis in models that do not include interactions between treatments and blocks. Treating the block effects as random has been recommended in the literature for balanced incomplete block designs (BIBD) because it results in smaller variances of treatment contrasts. This reduction...

article

The efficacy, tolerability, and safety of 1200 mg/d of oxaprozin and 1500 mg/d of nabumetone in the treatment of patients with osteoarthritis of the knee

William Makarowski, Arthur Weaver, Bernard Rubin, Jacques Caldwell, more

Clinical Therapeutics > 1996 > 18 > 1 > 114-124

This 6-week, multicenter, double-masked, placebo-controlled study compared the efficacy, tolerability, and safety of the recommended starting dose of oxaprozin (1200 mg/d) and a 1500-mg/d dose of nabumetone in the treatment of patients with moderate-to-severe osteoarthritis (OA) of the knee. A total of 347 patients with a mean age of 61.1 years were randomized to receive oxaprozin (116 patients),...

article

Comparison of the efficacy and safety of oxaprozin and nabumetone in the treatment of patients with osteoarthritis of the knee

Arthur Weaver, Bernard Rubin, Jacques Caldwell, F. Gilbert McMahon, more

Clinical Therapeutics > 1995 > 17 > 4 > 735-745

This multicenter, 6-week, double-blind, placebo-controlled, parallel-group study compared the efficacy and safety of oxaprozin 1200 mg once daily with that of nabumetone 1000 mg once daily in patients with moderate-to-severe osteoarthritis (OA) of the knee. To be eligible, patients had to experience a flare of OA within 2 weeks of discontinuing their usual OA medication (nonsteroidal anti-inflammatory...

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Search results for: Jitendra Ganju

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