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Assurance
Published in Andrew P. Grieve, Hybrid Frequentist/Bayesian Power and Bayesian Power in Planning Clinical Trials, 2022
A non-inferiority trial is designed to show that a new treatment is no more than a small amount less effective than a given reference treatment, generally the current SOC, which is sometimes referred to as being “not acceptably different”. This type of trial design is most often used when the new treatment is in some way cheaper, safer or in its form, more convenient than the SOC. For example, the new treatment may be given QD rather than BID and might therefore be preferable if not appreciably less effective.
Research Protocol
Published in Abhaya Indrayan, Research Methods for Medical Graduates, 2019
What is the exact design of the study? Is it descriptive or analytical? If analytical, is it observational (prospective, retrospective, or cross-sectional), experimental, or a human trial? If it is a trial, is it without parallel control (before–after, crossover, repeated measures, etc.) or with a parallel control group? Is it a superiority trial, equivalence trial, or a noninferiority trial? Is the experimental design one-way, two-way, or what?
Sample Size Calculations for Phase III Trials in Oncology
Published in Susan Halabi, Stefan Michiels, Textbook of Clinical Trials in Oncology, 2019
Non-inferiority phase III oncology trials are becoming increasingly prevalent [18] are have a dedicated chapter in this book (Chapter 8). A non-inferiority trial is defined as a trial with the objective of demonstrating that an investigational treatment is not clinically worse than the standard of treatment by more than a pre-specified boundary (i.e., the non-inferiority margin) [19]. Such trials are useful for comparing new treatments that are thought to bring advantages over the standard treatment in terms of costs, safety, or more convenient schedules of administration, but with a clinically acceptable loss of efficacy. According to ICH E9, a one-sided confidence interval should be used in non-inferiority trials (we discuss this matter in Section 7.6.1) [8].
Issues in antibiotic therapy for hospital-acquired and ventilator-associated pneumonia: emerging concepts to improve outcomes
Published in Expert Opinion on Pharmacotherapy, 2021
Syed Nazeer Mahmood, Andrew F. Shorr
One tactic for improving outcomes in MDR GNB includes the use of combination therapy, especially with colistin. Current guidelines suggest that combination treatment may offer a benefit but comment that prospective data is lacking to support this hypothesis [32]. Paul et al., addressed this concern by completing a randomized trial comparing colistin monotherapy to colistin combined with meropenem [33]. The authors relied on high-dose colistin (4.5 million units twice daily) and high doses of meropenem (2 gm every 8 h) as an extended infusion. Different from many of the studies reported above, the authors designed this study as a superiority rather than non-inferiority trial. CRAB was the most common organism isolated. Clinical failure and mortality rates were high in both arms and did not differ [33]. Super-infection and the emergence of new in vitro resistance also occurred frequently in both sets of patients. Nephrotoxicity also occurred commonly across the study population [33]. Hence, it appears that combination therapy does not offer a valuable strategy when considering the administration of colistin.
Comparison of outcome between nonoperative and operative treatment of medial epicondyle fractures
Published in Acta Orthopaedica, 2020
Petra Grahn, Tero Hämäläinen, Yrjänä Nietosvaara, Matti Ahonen
This is a comparative study of 81 consecutive children prospectively collected who had sustained a > 2 mm displaced medial epicondyle fracture treated by surgeon’s preference either by immobilization or by ORIF with a high follow-up rate, 81/83. Treatment was not randomized, which may cause a bias. Mean age of patients in the nonoperative group was lower than in the ORIF group. We do not have an obvious explanation for this discrepancy, but in general younger children less often require operative treatment in pediatric orthopedic trauma, which may have had an effect on selecting treatment modality. CTs had not been taken routinely and the exact fracture displacement could not therefore be measured. Regardless of treatment some patients remain symptomatic under valgus stress. This raises the question as to whether our treatment decisions are based on the right parameters, e.g., displacement of the fracture fragment vs. medial collateral ligament injury. In light of the shortcomings of this study we have been granted ethical review board permission to start a randomized control trial conducted as a non-inferiority trial.
Bioequivalence studies with anti-TNF biosimilars
Published in Expert Opinion on Biological Therapy, 2019
Mercedes Gimeno-Gracia, Carla J. Gargallo-Puyuelo, Fernando Gomollón
NOR-SWITCH trial deserves special attention, because it is the only controlled and randomized study that evaluates switching [71]. This trial tested the interchangeability from IFX to CT-P13 in patients with different diseases: IBD, RA, AS, psoriasic arthritis and chronic plaque psoriasis. Patients included must be on stable treatment with Remicade® for at least 6 months and were randomized 1:1 to either continue IFX or switch to CT-P13. The study was designed as a non-inferiority trial (prespecified non-inferiority margin of 15%). Finally, 481 patients were followed for 52 weeks. The authors did not observe significant increase in disease worsening between originator and biosimilar group. In particular, 155 patients with CD and 93 with UC were included. Disease worsening was reported in 21.2% vs. 36.5% in originator and biosimilar CD group and in 9.1% vs. 11.9% in originator and CT-P13 UC group. Moreover, there were no differences in safety or immunogenicity. However, this study also has some design limitations and its results cannot yet be generalized to other biologicals medicines and their biosimilars.