Response: Patient Costs on Clinical Trials

Patient perspectives on phase 0 clinical trials.

Phase 0 clinical trials are considered first-in-human studies that require extensive agent characterization and target assay development before administration. Phase 0 clinical trial goals can include assessing the pharmacokinetic-pharmacodynamic relationships of an investigational drug. They cover the rational transition from preclinical to clinical drug development, which includes an assessme...

Patient-centered clinical trials.

We apply Bayesian decision analysis (BDA) to incorporate patient preferences in the regulatory approval process for new therapies. By assigning weights to type I and type II errors based on patient preferences, the significance level (α) and power (1-β) of a randomized clinical trial (RCT) for a new therapy can be optimized to maximize the value to current and future patients and, consequently,...

Patient representatives’ views on patient information in clinical cancer trials

BACKGROUND Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the w...

Patient confidence in clinical trials.

Evaluation of Clinical Trials

In a number of important clinical issues such as evaluation of the efficacy or effectiveness of therapeutic or preventive interventions as well as for comparing the harms of interventions, randomized controlled trials (RCTs) provide the highest levels of evidence, either directly or indirectly. It is obvious that critical appraisal of these studies to assess their validity and precision is of p...