
Many clinical trials organizations use regular interim analyses to monitor the accruing results in large clinical trials. In disease areas such as cancer, where survival is usually a major outcome variable, ethical considerations may lead to a stipulated requirement for data monitoring of mortality. This monitoring has frequently taken the form of limiting interim analyses to be few in number, and specifying an extreme p-value of, for example, p < 0.001 or p < 0.01 as grounds for early termination of the trial. Group-sequential methods are also used. However, none of these approaches formally assesses the impact that the results of a clinical trial may have upon clinical practice. Thus a trial might be terminated early because of apparent treatment benefits, but might fail to influence sceptical clinicians to modify their future treatment policy. We discuss the application of Bayesian methods, including the use of uninformative, sceptical and enthusiastic priors, and demonstrate that the necessary calculations are both straightforward to perform and easy to interpret statistically and clinically. Methods are illustrated with interim analyses of a clinical trial in oesophageal cancer.
Clinical Trials as Topic, Likelihood Functions, Esophageal Neoplasms, Bayes Theorem, Combined Modality Therapy, Survival Analysis, Esophagectomy, Treatment Outcome, Chemotherapy, Adjuvant, Data Interpretation, Statistical, Humans, Proportional Hazards Models
Clinical Trials as Topic, Likelihood Functions, Esophageal Neoplasms, Bayes Theorem, Combined Modality Therapy, Survival Analysis, Esophagectomy, Treatment Outcome, Chemotherapy, Adjuvant, Data Interpretation, Statistical, Humans, Proportional Hazards Models
| selected citations These citations are derived from selected sources. This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | 81 | |
| popularity This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network. | Top 10% | |
| influence This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically). | Top 1% | |
| impulse This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network. | Top 10% |
