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Activity Number: 463 - Topics in Biostatistics
Type: Contributed
Date/Time: Thursday, August 6, 2020 : 10:00 AM to 2:00 PM
Sponsor: Biopharmaceutical Section
Abstract #313222
Title: Does Concomitant Medication Tapering Impact Interim Analysis Projection
Author(s): Grace Liu* and Karen Xia
Companies: Johnson & Johnson and Johnson & Johnson
Keywords: interim analysis ; family-wise error rate; study cut off projection; study power; Study design; concomitant medication tapering

Systemic corticosteroids play an integral role in the management of many inflammatory and immunologic conditions such as Crohn’s disease and ulcerative colitis. Corticosteroids are anti-inflammatory medications that are used to help reduce inflammation in the digestive tract and relieve symptoms that it causes. Unlike other forms of anti-inflammatory drugs, corticosteroids are not used long-term to help patients to stay in remission. One of the reasons for this is that corticosteroids are not able to heal the that IBD can cause. Instead, corticosteroid treatment for IBD is focused on: Short-term treatment to help relieve moderate or severe symptom flare-ups and Helping the patient to enter remission more quickly. Therefore, in most clinical trial design, corticosteroids tapering is allowed but tapering time is varied, it ranges from 6-week to 12-week. When will be a better tapering time in speaking of study results and its read out time. In this talk, we will discuss the association between corticosteroids tapering and the interim analysis timeline projection. Simulation study will be conducted to examine the study power by controlling family-wise error rate.

Authors who are presenting talks have a * after their name.

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