Learning From Clinical Randomized Trials

Learning from hackers: open-source clinical trials.

Open sharing of clinical trial data has been proposed as a way to address the gap between the production of clinical evidence and the decision-making of physicians. A similar gap was addressed in the software industry by their open-source software movement. Here, we examine how the social and technical principles of the movement can guide the growth of an open-source clinical trial community.

Randomized Clinical Trials in HFpEF

Heart Failure With Preserved Ejection Fraction Heart failure with preserved ejection fraction (HFpEF) or diastolic heart failure (HF) accounts for approximately half of HF cases in the community, and the portion of HF with preserved ejection fraction (EF) is increasing. Patients with HFpEF have limited functional capacity and poor prognosis. With ongoing shifts in the age distribution of the po...

Blindness in Randomized Controlled Trials

In combination with randomization, blinding or masking is an important factor in randomized controlled trials (RCTs), particularly in trials that assess therapeutic effects. Here an attempt is made to explain blindness and why it is important. In clinical trials, blinding is defined as the condition imposed on a study in which study participants, health care providers and assessors collecting o...

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...

Dual-Controller Regimens I: Data From Randomized, Controlled Clinical Trials