scholarly journals Individualizing endpoints in randomized clinical trials to better inform individual patient care: the TARGET proposal

Critical Care ◽  
2016 ◽  
Vol 20 (1) ◽  
Author(s):  
Theodore J. Iwashyna ◽  
Adam M. Deane
Keyword(s):  
Clinical Trials ◽  
Patient Care ◽  
Randomized Clinical Trials

Subgroup Analyses in Reporting of Phase III Clinical Trials in Solid Tumors

2015 ◽  
Vol 33 (15) ◽  
pp. 1697-1702 ◽  
Author(s):  
Sheng Zhang ◽  
Fei Liang ◽  
Wenfeng Li ◽  
Xichun Hu
Keyword(s):  
Clinical Trials ◽  
Patient Care ◽  
Randomized Clinical Trials ◽  
Consort Statement ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Subgroup Analyses ◽  
The Consort Statement ◽  
Test Use ◽  
Interaction Test

Purpose Treatment decisions in clinical oncology are guided by results from phase III randomized clinical trials (RCTs). The results of subgroup analyses may be potentially important in individualizing patient care. We investigated the appropriateness of the use and interpretation of subgroup analyses in oncology RCTs on the basis of the CONSORT statement requirements. Methods Phase III RCTs published between January 1, 2011, and December 31, 2013, were reviewed to identify eligible studies of solid tumor treatments. Information related to the subgroup analyses included prespecification, number, subgroup factors, interaction test use, and claim of subgroup difference. Results A total of 221 publications reporting data on 184,500 patients were analyzed. One hundred eighty-eight (85%) RCTs were reported with subgroup analyses. Of those, 146 (78%) trials were reported with at least six subgroups. For the majority of trials with subgroup analyses (173; 92%), the actual number of subgroup analyses conducted cannot be determined. Only 59 (31%) RCTs were reported with fully prespecified subgroups and only 64 (34%) trials were reported with interaction tests. In addition, 102 (54%) RCTs were reported with claims of subgroup differences. Of those, only 18 claims of RCTs (18%) were based on significant interaction test results. Conclusion The reporting of subgroup analyses in contemporary oncology RCTs is neither uniform nor complete; it requires improvement to ensure consistency and to provide critical information for guiding patient care. Major problems include testing of a large number of subgroups, subgroups without prespecifications, and inadequate use of interaction tests.

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.

Ongoing randomized clinical trials for the treatment of thrombosis in the antiphospholipid syndrome

2001 ◽  
Vol 21 (02) ◽  
pp. 77-81 ◽  
Author(s):  
G. Finazzi
Keyword(s):  
Clinical Trials ◽  
Large Scale ◽  
Low Dose ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Collaborative Study ◽  
Clinical Problem ◽  
Vascular Events ◽  
Dose Oral ◽  
Adverse Pregnancy

SummaryThrombotic events are a major clinical problem for patients with antiphospholipid antibodies (APA). However, current recommendations for their prevention and treatment are still based on retrospective studies. Data from large scale, prospective clinical trials are required to ultimately identify the optimal management of these patients. To date, at least four randomized studies are underway. The WAPS and PAPRE clinical trials are aimed to establish the correct duration and intensity of oral anticoagulation in APA patients with major arterial or venous thrombosis. The WARSS-APASS is a collaborative study to evaluate the efficacy and safety of aspirin or low-dose oral anticoagulants in preventing the recurrence of ischemic stroke. The recently announced UK Trial compares low-dose aspirin with or without low-intensity anticoagulation for the primary prevention of vascular events in APA-positive patients with SLE or adverse pregnancy history, but still thrombosis-free. It is hoped that the results of these trials will be available soon since clinicians urgently need more powerful data to treat their patients with the APA syndrome.

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