How to Work with Research Naive Sites

Investigative clinical sites make unparalleled contributions to the body of scientific knowledge; without their dedication to advancement through quality research along with the many partners necessary to conduct clinical trials, the ongoing evolution of medical care would come to a halt. In the last 10-15 years, the need to find new patient populations in tandem […]

New Transparency Proposal That Could Change Everything!

Among the many groups that have an interest in improving global healthcare, medical journal editors have enormous influence. Journal editors have been pioneers when it comes to encouraging research transparency.  In 2004 editors from top medical journals authored an editorial requiring registration in a public trials registry.  This led to an unprecedented increase in the […]

This Week We’re Talking About: Big Data, Diversity, and WAK

A busy week in clinical research but we think you’ll enjoy these 3 intriguing articles! 1.  FDA Greenlights First Human Study of Wearable Artificial Kidney  The FDA recently gave the green light to medical researchers to begin the first human study of the device in the United States. WAK, a small dialysis machine that is worn like a belt and […]

Using Diversity as a Study Metric in CTMS

Clinical Trial Participation Part 3: The third of an ongoing series of articles examining critical issues concerning clinical trial participation Using Diversity as a Study Metric in CTMS In part three (click here for Part 1 and Part 2) of this ongoing series, we examine how Clinical Trial Management Systems (CTMS) can assist in helping to monitor diversity […]

This Week We’re Talking About: Data, Contrave, and Arthritis

Hot topics this week include clinical trial data, the new weight management drug Contrave, and good news for those suffering with rheumatoid arthritis! 1.  NICE to Seek Greater Access to Clinical Trial Data  NICE (National Institute for Health and Care Excellence) will ask the European regulatory authorities for access to clinical trial data if relevant […]

This Week We’re Talking About: Amino Acid, FDA, and EU Clinical Trials

 A new Amino Acid, the FDA and New Regulations in Europe are our main topics of discussion this week! 1.  A New Synthetic Amino Acid for an Emerging Class of Drugs  A synthetic amino acid has been developed that can impact the 3D structure of bioactive peptides and enhance their potency. 2.  FDA Fast-Tracks Merck & Co Antibiotic  Relebactam, […]

Lack of Elderly Participation in Clinical Trials

Clinical Trial Participation Part 2: The second of an ongoing series of articles examining critical issues concerning clinical trial participation Lack of Elderly Participation in Clinical Trials In part two of this ongoing series, we turn to the issue of the lack of elderly participation in clinical trials. According to the Administration on Aging, there […]

Lack of Diversity in Clinical Trials

Clinical Trial Participation Part 1: The first of an ongoing series of articles examining critical issues concerning clinical trial participation. While clinical trials are the backbone of the development of new and innovative medicines to treat a wide variety of medical conditions in this country, volunteer participation is critical to examine the safety and effectiveness […]