Patient preferences and randomised clinical trials.

Patient preferences and randomised clinical trials.

Patient preferences in randomised controlled trials: conceptual framework and implications for research.

Patient preferences have recently been highlighted as a potential threat to the validity of randomised controlled trials (RCTs). Although there have been significant methodological and statistical developments in relation to these issues, comparatively little attention has been paid to the development of a conceptual model concerning preferences and their effects on decision-making. This articl...

Ethics of randomised clinical trials.

Up to now there are no generally accepted ethical guidelines for controlled studies. The issue is hardly discussed in the Helsinki Declaration even in its last version. The reason might be that in many of these studies it is difficult to determine whether to classify them as 'mere patient-care' or as research. If they are to be considered as mere patient-care, the doctor is under the obligation...

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,...

Multicentre randomised clinical trials in trauma care.

Multicentre clinical trials in trauma care are gaining prominence as a means of generating good-quality evidence to inform and influence clinical practice. We believe multicentre trials have an important role to play in supporting evidence-based practice, and further investment in such trials is justified.