The Ebola crisis brings into sharp contrast the importance of appropriate regulation for trials of new drugs. The “gold standard” in clinical research is the randomised trial, but the reliance on one ...

Precision oncology exploits genomic, immunologic, and other biomarkers to drive discovery, drug development, and clinical care for patients with cancer. Precision oncology helps devise individualized ...

In a trial of a new drug to cure cancer, 44 percent of 50 patients achieved remission after treatment. Without the drug, only 32 percent of previous patients did the same. The new treatment sounds ...

Multiplicity, or the use of many comparisons in a clinical trial, increases the likelihood that a chance association could be deemed causal. This problem commonly arises in clinical trials that have ...

In this special series, we aimed to include a wide perspective from regulators, bioethicists, statisticians, and clinician-scientists on the drug development continuum, focusing on challenges raised ...

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