NDLI: Adaptive Budgets in Clinical Trials

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Adaptive Budgets in Clinical Trials

Content Provider	Scilit
Author	Posch, Martin Bauer, Peter
Copyright Year	2013
Description	Journal: Statistics in Biopharmaceutical Research We consider situations where a drug developer gets access to additional financial resources when a promising result has been observed in a preplanned interim analysis during a clinical trial that should lead to the registration of the drug. First, the option that the drug developer completely puts the additional resources into increasing the second-stage sample size has been investigated. If investors invest more the larger the observed interim effect, this may not be a reasonable strategy. Then, additional sample sizes are applied when the conditional power is already very large and hardly any impact on the overall power can be expected. Nevertheless, further reducing the Type II error rate in promising situations may be of interest for a drug developer. In a second step, sample size was based on a utility function including the reward of registration (which was allowed to depend on the observed effect size at the end of the trial) and sampling costs. Utility as a function of the sample size may have more than one local maximum, one of them at the lowest per group sample size. For small effects, an optimal strategy could be to apply the smallest sample size accepted by regulators.
Related Links	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6485463/pdf
Ending Page	292
Page Count	11
Starting Page	282
e-ISSN	19466315
DOI	10.1080/19466315.2013.783504
Journal	Statistics in Biopharmaceutical Research
Issue Number	4
Volume Number	5
Language	English
Publisher	Informa UK Limited
Publisher Date	2013-11-01
Access Restriction	Open
Subject Keyword	Journal: Statistics in Biopharmaceutical Research Statistics and Probability Interim Analysis Sample Size Reassessment Sampling Costs
Content Type	Text

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