Clinical Trials

A checklist is associated with increased quality of reporting preclinical biomedical research: A systematic review

Irreproducibility of preclinical biomedical research has gained recent attention. It is suggested that requiring authors to complete a checklist at the time of manuscript submission would improve the quality and transparency of scientific reporting, …

Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010

Context Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable …

Empirical Study of Data Sharing by Authors Publishing in PLoS Journals

Background Many journals now require authors share their data with other investigators, either by depositing the data in a public repository or making it freely available upon request. These policies are explicit, but remain largely untested. We …

Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics

The US Food and Drug Administration (FDA) has developed a framework to use data gathered outside of clinical trials (eg, electronic health record [EHR] and insurance claims data) for evaluations of medical product safety and effectiveness. These …

Good clinical practice improves rigor and transparency: Lessons from the ACTIVE trial

Clinical trials are governed by principles of good clinical practice (GCP), which can strengthen the achievement of rigor, reproducibility, and transparency in scientific research. Rigor, reproducibility, and transparency are key for producing …

Increasing efficiency of preclinical research by group sequential designs

Despite the potential benefits of sequential designs, studies evaluating treatments or experimental manipulations in preclinical experimental biomedicine almost exclusively use classical block designs. Our aim with this article is to bring the …

Issues in the Registration of Clinical Trials

Public concerns about the perils associated with incomplete or delayed reporting of results from clinical trials has heightened interest in trial registries and results databases. Here we review the current status of trial registration efforts and …

Open Science 2.0: Towards a truly collaborative research ecosystem

Conversations about open science have reached the mainstream, yet many open science practices such as data sharing remain uncommon. Our efforts towards openness therefore need to increase in scale and aim for a more ambitious target. We need an …

Poor statistical reporting, inadequate data presentation and spin persist despite editorial advice

The Journal of Physiology and British Journal of Pharmacology jointly published an editorial series in 2011 to improve standards in statistical reporting and data analysis. It is not known whether reporting practices changed in response to the …

Public Availability of Published Research Data in High-Impact Journals

Background There is increasing interest to make primary data from published research publicly available. We aimed to assess the current status of making research data available in highly-cited journals across the scientific literature. Methods and …