Traditionally, clinical trials have been understood as continuous with clinical medicine. 1 In providing medical care for patients, the physician makes observations, investigates, tests hypotheses, and experiments with different treatments. Moreover, the exemplary physician is always learning how to improve treatment for future patients on the basis of clinical experience with current patients ...

The effect of placebo observed in schizophrenia clinical trials represents a growing problem that interferes with signal detection for treatments, increases costs of development, discourages investment in schizophrenia research and delays the introduction of new treatments. This paper seeks to clarify key issues related to this problem and identify potential solutions to them. Differences betwe...

We present guidelines to standardize the reporting of phase 1 and phase 2 neuro-oncology trials. The guidelines are also intended to assist with accurate interpretation of results from these trials, to facilitate the peer-review process, and to expedite the publication of important and accurate manuscripts. Our guidelines are summarized in a checklist format that can be used as a framework from...

Drug development continues to face challenges to successfully progress the most promising drug candidates through the stages of clinical trials. Given the increasing cost to develop a drug, methods are required to characterise early drug efficacy and safety. Imaging techniques are increasingly used in oncological clinical trials to provide evidence for decision making. With the application of c...

In the past century there have been incredible advances in the field of medical research, but what hinders translation of this knowledge into effective treatment for human disease? There is an increasing focus on the failure of many research breakthroughs to be translated through the clinical trial process and into medical practice. In this mini review, we will consider some of the reasons that...

Modern clinical trials provide the evidence for most therapeutic advances, and that evidence, expressed in a statistical format, is used to draw inferences about a population from the study's results. Clinician judgment translates these inferences for best individual patient care, but many clinicians struggle with the statistical interpretation of trial results. This review provides a clinical ...

Volume 33, no. 12 care to complement clinical trials. standard for only 2 years in some settings? Need for longterm observations in Why are only 50% of courses of anti-tumor necrosis factor agents continued Theodore Pincus, Yusuf Yazici and Ronald van Vollenhoven http://www.jrheum.org/content/33/12/2372.citation J Rheumatol 2006;33;2372-2375 http://www.jrheum.org/alerts 1. Sign up for TOCs and...

New vaccines are urgently needed if we want to reach the goal of substantially reducing the incidence of tuberculosis by 2050. Despite a steady increase in funding over the past decade, there is still a striking financial shortfall for vaccine research and development for tuberculosis. Yet, around ten vaccine candidates have left the laboratory stage and entered clinical trials. These vaccines ...

Treating rheumatoid arthritis (RA) with a goal or «Treat to target» strategy is a therapeutic proposal taken from cardiovascular and endocrine literature. It proposes that the therapeutic target in RA should be a state of remission, or an alternative goal could be a low disease activity. Rheumatologists should measure and register disease activity in every clinical visit and if the goal has not...

Quality of cancer care is difficult to define and to evaluate. Here we consider three components represented by the questions: (i) Is the right question treatment being given? (ii) Is it being done well? and (iii) Is the patient being treated as well as the disease? Determining the right treatment requires a hierarchy of evidence from clinical trials, and high quality clinical trials to determi...