Physio

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BOOK CHAPTER

Biostatistics and Bioinformatics in Clinical Trials

Donald A. Berry and Kevin R. Coombes

Abeloff's Clinical Oncology, 19, 282-293.e2

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Summary of Key Points

• The process of conducting cancer research must change in the face of prohibitive costs and

limited patient resources.

• Biostatistics has a tremendous impact on the level of science in cancer research, especially in

the design and conducting of clinical trials.

• The Bayesian statistical approach to clinical trial design and conduct can be used to develop

more efficient and effective cancer studies.

• Modern technology and advanced analytic methods are directing the focus of medical research

to subsets of disease types and to future trials across different types of cancer.

• A consequence of the rapidly changing technology for generating “omics” data is that biological

assays are often not stable long enough to discover and validate a model in a clinical trial.

• Bioinformaticians must use technology-specific data normalization procedures and rigorous

statistical methods to account for sample collecting, batch effects, multiple testing, confounding

covariates, and any other potential biases.

• Best practices in developing prediction models include public access to the information,

rigorous validation of the model, and model lockdown prior to its use in patient care

management.

Introduction

Biostatistics and bioinformatics deal with quantitative information in medical research. Both

disciplines involve data analysis and experimental design. No sharp delineation exists between the

two, but bioinformatics tends to deal with data in many dimensions, so-called “big data,” such as in

genomics. Both disciplines are concerned with making inferences and thus use similar...