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Christy Chuang-Stein
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Book Series
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Chapter
The Parallel Between Clinical Trials and Diagnostic Tests
In this chapter, we compare successive trials designed and conducted to assess the efficacy of a new drug to a series of diagnostic tests. The condition to diagnose is whether the new drug has a clinically mea...
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Chapter
Designing Phase 4 Trials
Phase 4 trials are conducted for a variety of reasons. These include investigating a marketed drug in pediatric patients, comparing a drug head-to-head with another drug, investigating the effect of a drug at ...
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Chapter
Characteristics of a Diagnostic Test
A diagnostic test is often performed to diagnose a disease or to sub-classify a disease regarding its severity and susceptibility to treatment. In recent years, companion diagnostics have been developed to pre...
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Chapter
Other Metrics That Have Been Proposed to Optimize Drug Development Decisions
Cost is an important consideration when planning a clinical development program. Yet, many drug development programs do not formally incorporate cost into their decision process. In this chapter, we review two...
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Chapter
Adaptive Designs
Adaptive designs can potentially help with quantitative decision making by allowing designs to be amended so that better decisions can be made in the light of emerging data. The chapter starts with some princi...
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Book
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Chapter
A Frequentist Decision-Making Framework
In this chapter, we review the Frequentist approach to hypothesis testing and in particular the two-action decision problem. In the context of drug development, the two actions correspond to progressing or not...
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Chapter
Choosing Metrics Appropriate for Different Stages of Drug Development
In this chapter, we give an overview of metrics that are useful to evaluate designs for determining if a new drug is efficacious at each of the three premarketing clinical development stages. The three stages ...
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Chapter
Designing Dose–Response Studies with Desired Characteristics
According to ICH-E4, “Elucidation of the dose–response function” is a key stage in drug development. Consequently, designing a dose–response study with the desired characteristics is an important activity in d...
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Chapter
Discounting Prior Results to Account for Selection Bias
In this chapter, we consider possible selection bias that can occur due to the fact that a Phase 2 trial is usually selected for use in future trial planning only when it has produced a positive result. We fir...
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Chapter
Additional Topics
The final chapter of the book covers selected topics that affect design and decision choices at all stages of drug development. Examples include the assessment of program-level success probability when a progr...
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Chapter
Clinical Testing of a New Drug
Develo** a new drug is a high-risk and high-reward enterprise. The high risk is reflected by the low success rate of turning a new molecular entity (NME) into an approved drug even after the NME has successf...
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Chapter
Incorporating Information from Completed Trials and Other Sources in Future Trial Planning
Drug development is a continuum. Information from completed trials and other sources may be available when we design a new trial. In this chapter, we consider the Bayesian approach to incorporate existing info...
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Chapter
Designing Proof-of-Concept Trials with Desired Characteristics
A proof-of-concept (POC) study is where a developer finds out for the first time if a new drug has any effect on the endpoint of interest in targeted patients, and if the drug appears to have an effect, whethe...
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Chapter
Designing Confirmatory Trials with Desired Characteristics
By the time a new drug moves into the confirmatory stage, its developer should in theory have a reasonable amount of information on the effect of the drug on several efficacy endpoints. Based on this assumptio...
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Book
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Chapter
Characteristics of a Diagnostic Test
A diagnostic test is often performed to diagnose a disease or to subclassify a disease regarding its severity and susceptibility to treatment. In recent years, companion diagnostics have been developed to pres...
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Chapter
Designing Phase 4 Trials
Phase 4 trials are conducted for a variety of reasons. These include investigating a marketed drug in pediatric patients, comparing a drug head-to-head with another drug, investigating the effect of a drug at ...
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Chapter
A Frequentist Decision-Making Framework
In this chapter, we review the Frequentist approach to hypothesis testing and in particular the two-action decision problem. The Frequentist approach to statistical inference involves examining probability via...
