Tag: Trials

Witnesses clash in Tennessee abortion wait period trial

Expert witnesses on Wednesday presented dueling views of whether Tennessee’s 48-hour waiting period before abortion helps or hinders women’s decision making. Interested in Abortion Rights? Five of Tennessee’s seven abortion clinics are suing in federal court in Nashville over the law, which requires women to make two separate trips to an abortion clinic, first for

World-first coeliac disease vaccine enters Phase 2 trials

A coeliac disease vaccine that aims to protect patients from the harmful effects of gluten has entered Phase 2 clinical trials in Melbourne. Following the commencement of global trials led by US-based pharmaceutical company ImmusanT Inc., the Australian trials will commence at the Royal Melbourne Hospital Clinical Trials Centre in Melbourne and then roll out

Trials Supporting FDA Approval of Breakthrough Drugs Examined

TUESDAY, July 17, 2018 — Pivotal trials supporting U.S. Food and Drug Administration approvals granted Breakthrough Therapy designation often lack randomization, double-blinding, and control groups, according to a research letter published in the July 17 issue of the Journal of the American Medical Association. Jeremy Puthumana, from the Yale University School of Medicine in New

Harms Reporting Limited in Trials of Prebiotics, Probiotics, Synbiotics

MONDAY, July 16, 2018 — A considerable number of randomized controlled trials (RCTs) of probiotics, prebiotics, or synbiotics do not report harms-related data and/or safety results, according to a review published online July 17 in the Annals of Internal Medicine. Aïda Bafeta, Ph.D., from the Université Paris Descartes-Sorbonne Paris Cité, and colleagues examined how harms-related

New study reveals how electronic health records can benefit clinical trials

The study entitled “Long term extension of a randomised controlled trial of probiotics using electronic health records” led by researchers in the Swansea University Medical School and the College of Human and Health Sciences, was published in Scientific Reports. The findings demonstrate the potential of using anonymised routinely collected electronic health records, such as those

Not enough women included in some heart disease clinical trials

Women are underrepresented in clinical trials for heart failure, coronary artery disease and acute coronary syndrome but proportionately or overrepresented in trials for hypertension, atrial fibrillation and pulmonary arterial hypertension, when compared to incidence or prevalence of women within each disease population, according to a study in the Journal of the American College of Cardiology.

Trials in Africa support conditional day 3 follow-up for children with fever

Children in sub-Saharan African settings with uncomplicated fever may be safely managed with conditional, rather than universal, 3-day follow-up with a community health worker (CHW), according to two cluster-randomized, community-based non-inferiority trials published this week in PLOS Medicine. The trials, conducted by Luke C. Mullany of the Johns Hopkins Bloomberg School of Public Health, Baltimore,