";s:4:"text";s:14327:"Objectives were to discuss current standards and strategies to address multiplicity in clinical trials and to identify issues where guidance is missing so far. First published: 15 … Search for more papers by this author. The document provide guidances on when an adjustment for multiplicity should be implemented. 5. Journal of Biopharmaceutical Statistics 2011; 21:610–634. End-point interpretation in clinical trials: the case for discipline. When you conduct interim analysis you need to correct for multiplicity. In certain fields it is known as the look-elsewhere effect.. For example, if statistical tests are with multiplicity and multiplicity arising from interim decisions. Multiplicity Problems in Clinical Trials – A Regulatory Perspective Mohammad F. Huque, Ph.D. Office of Biostatistics OTS, CDER/FDA Kathleen Fritsch, Ph.D., Division of … Multiplicity in Clinical Trials. What is the study objective for an early-phase versus a later phase adaptive clinical trial? ♦ Huque MF, Alosh M, Bhore R. Addressing multiplicity issues of a composite endpoint and its components in clincal trials. Multiplicity in clinical trials (cont’d) • Example: Consider a drug trial for Alzheimer’s disease that compares a new drug to control on two PEs: • ADAS-Cog (cognition scale) and • CIBIC plus (clinical global scale). Multiplicity, or the use of many comparisons in a clinical trial, increases the likelihood that a chance association could be deemed causal. The more inferences are made, the more likely erroneous inferences are to occur. While there are so many articles related to multiplicity, I find the following articles suitable for my taste and with practical discussions. The usual concern with multiplicity is 96 that, if it is not properly handled, unsubstantiated claims for the efficacy of a drug may be made as a 97 consequence of an inflated rate of false positive conclusions. Michael D. Hughes. Multiplicity Issues in Clinical Trials-Look at it with a magnifying glass! Controlled Clinical Trials 1999; 20:40–49. Multiplicity in clinical trials may appear under several different guises: multiple endpoints, multiple treatment arm comparisons, and multiple looks at … ♦ Fisher LD. Search for more papers by this author. Michael D. Hughes. Proschan and Waclawiw (2000) Practical Guidelines for Multiplicity Adjustment in Clinical Trials. ♦ Moye LA. • Clinical win criterion: Statistical test for the treatment effect needs to be statistically significant at the 0.025 95 Multiplicity of inferences is present in virtually all clinical trials. Madhusudhan Bandi, Hyderabad, India ABSTRACT With recent trends in the drug development process, modern clinical trials have gone a step ahead in evaluating safety and efficacy of new treatments with inclusion of multiple objectives in a trial and its interpretation. In the later stage of clinical research, multiplicity problems can be formulated with better focus, depending on whether the study is for exploration to estimate or select design elements or for labeling consideration. In statistics, the multiple comparisons, multiplicity or multiple testing problem occurs when one considers a set of statistical inferences simultaneously or infers a subset of parameters selected based on the observed values. London School of Hygiene and Tropical Medicine, London, UK. London School of Hygiene and Tropical Medicine, London, UK. Key opinion leaders from regulatory agencies, academic institutes and A chance association could be deemed causal discuss current standards and strategies address. 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