|Title||Enrollment and Stopping Rules for Managing Toxicity Requiring Long Follow-Up in Phase II Oncology Trials.|
|Publication Type||Journal Article|
|Year of Publication||2015|
|Authors||Song, Guochen, and Anastasia Ivanova|
|Journal||J Biopharm Stat|
|Keywords||Algorithms, Antineoplastic Agents, Clinical Trials, Phase II as Topic, Data Interpretation, Statistical, Early Termination of Clinical Trials, Follow-Up Studies, Humans, Research Design, Research Subjects|
Monitoring of toxicity is often conducted in Phase II trials in oncology to avoid an excessive number of toxicities if the wrong dose is chosen for Phase II. Existing stopping rules for toxicity use information from patients who have already completed follow-up. We describe a stopping rule that uses all available data to determine whether to stop for toxicity or not when follow-up for toxicity is long. We propose an enrollment rule that prescribes the maximum number of patients that may be enrolled at any given point in the trial.
|Alternate Journal||J Biopharm Stat|
|Original Publication||Enrollment and stopping rules for managing toxicity requiring long follow-up in phase II oncology trials.|
|PubMed Central ID||PMC4689581|
|Grant List||P01 CA142538 / CA / NCI NIH HHS / United States |
R01 CA120082 / CA / NCI NIH HHS / United States
Enrollment and Stopping Rules for Managing Toxicity Requiring Long Follow-Up in Phase II Oncology Trials.