The aerial view of the concept of data sharing is beautiful. What could be better than having high-quality information carefully reexamined for the possibility that new nuggets of useful data are lying there, previously unseen? The potential for leveraging existing results for even more benefit pays appropriate increased tribute to the patients who put themselves at risk to generate the data. The moral imperative to honor their collective sacrifice is the trump card that takes this trick. However, many of us who have actually conducted clinical research, managed clinical studies and data collection and analysis, and curated data sets have . . .
We explore whether the number of null results in large National Heart Lung, and Blood Institute (NHLBI) funded trials has increased over time.
To reanalyse SmithKline Beecham’s Study 329 (published by Keller and colleagues in 2001), the primary objective of which was to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of adolescents with unipolar major depression. The reanalysis under the restoring invisible and abandoned trials (RIAT) initiative was done to see whether access to and reanalysis of a full dataset from a randomised controlled trial would have clinically relevant implications for evidence based medicine.
We want to clarify, given recent concern about our policy, that the Journal is committed to data sharing in the setting of clinical trials. As stated in the Institute of Medicine report from the committee(1) on which I served and the recent editorial by the International Committee of Medical Journal Editors (ICMJE),(2) we believe there is a moral obligation to the people who volunteer to participate in these trials to ensure that their data are widely and responsibly used. Journal policy will therefore follow that outlined in the ICMJE editorial and the IOM report: when appropriate systems are in place, . . .
To determine rates of publication and reporting of results within two years for all completed clinical trials registered in ClinicalTrials.gov across leading academic medical centers in the United States.
Aging is variably but inevitably accompanied by declines in health; concomitantly, in men, circulating sex-steroid levels fall with age.(1) To what extent these two processes are causally linked and whether testosterone therapy can prevent or ameliorate important age-related problems have been major issues in men’s health. In 2003, a committee assembled by the Institute of Medicine (IOM) found a paucity of randomized, placebo-controlled clinical trials involving older men and noted a lack of definite evidence that testosterone therapy conferred benefits.(2) The committee recommended that clinical trials be initiated, first to evaluate the efficacy of testosterone supplementation in older men and . . .
Curcumin is a constituent (up to ∼5%) of the traditional medicine known as turmeric. Interest in the therapeutic use of turmeric and the relative ease of isolation of curcuminoids has led to their extensive investigation. Curcumin has recently been classified as both a PAINS (pan-assay interference compounds) and an IMPS (invalid metabolic panaceas) candidate. The likely false activity of curcumin in vitro and in vivo has resulted in >120 clinical trials of curcuminoids against several diseases. No double-blinded, placebo controlled clinical trial of curcumin has been successful. This manuscript reviews the essential medicinal chemistry of curcumin and provides evidence that curcumin is an unstable, reactive, nonbioavailable compound and, therefore, a highly improbable lead. On the basis of this in-depth evaluation, potential new directions for research on curcuminoids are discussed.
Options for leveraging available telemedicine technologies, ranging from simple webcams and telephones to smartphone apps and medical-grade wearable sensors, are evolving faster than the culture of clinical research. Until recently, most clinical trials relied on paper-based processes and technology. This cost- and labor-intensive system, while slowly changing, remains an obstacle to new drug development. Alternatives that use existing tools and processes for collecting real-world data in home settings warrant closer examination.
Mortality from coronary heart disease (CHD) remains at quite notable levels. Research on the risk factors and the treatment of CHD has focused on physiological factors, but there is an increasing amount of evidence connecting mental health and personality traits to CHD, too. The data concerning the connection of CHD and dispositional optimism and pessimism as personality traits is relatively scarce. The aim of this study was to investigate the connection between optimism, pessimism, and CHD mortality.
We aimed to derive and validate a clinical decision rule (CDR) for suspected cardiac chest pain in the emergency department (ED). Incorporating information available at the time of first presentation, this CDR would effectively risk-stratify patients and immediately identify: (A) patients for whom hospitalisation may be safely avoided; and (B) high-risk patients, facilitating judicious use of resources.