An Era of Innovation in Phase 1 Clinical Trials

Clinical research is undergoing a period of rapid transformation. New technology that focuses on greater speed and efficiency is shaking up all aspects of the research process, from Phase 1 clinical trials to post-market surveillance. The growing use of artificial intelligence, eClinical tools, and mHealth is helping researchers to more quickly overcome challenges with patient … Read More →

eSource PRO: A Phase I Patient Engagement Tool

A major driver of patient recruitment hurdles in Phase I clinical trials could be described as the perceived distance between researchers and subjects. Researchers can appear only interested in mining patients for data, unconcerned with any health risks posed by a compound whose safety profile has yet to be determined. This perception is not-so-affectionately referred … Read More →

What Does Immunotherapy Mean for Trial Design?

It has now been a year since we first posted about immunotherapy on this blog, and several years since the first FDA approval of an immunotherapy treatment for cancer. For anyone paying attention, it’s difficult to avoid the conclusion that immunotherapy is one of today’s hottest topics not only in oncology, but in healthcare at … Read More →

3 Early Obstacles in Phase I, and How to Address Them

Anyone with an involvement or interest in clinical research is likely to be aware of the challenges sponsors face in getting their compounds approved by the FDA. The low rates at which drugs make it all the way through the research process is a favorite topic of blogs and journalistic outlets covering clinical research. Many … Read More →

Taking On a New Competitive Landscape in Phase I

Medical discoveries, major investments from the private and public sectors, and growing markets for certain treatments have taken the engines of drug development from a purr to a roar. But like any healthy industry, a byproduct of boom times is intense competition. Some CROs have, to an extent, insulated themselves from this competition by focusing … Read More →

Phase I in the Age of Precision Medicine and Patient Diversity

As clinical research evolves and becomes more refined, the industry is coming to acknowledge a simple truth: that everyone is different. A drug that works wonders for one individual may have little to no effect on, or even be detrimental to, another. Alternatively, the discovery that a treatment is ineffective or dangerous in a small … Read More →

How Dictionary Coding Can Enhance Phase I

Many of the challenges in clinical research stem from the experience gap between researchers and their patients. The research teams who conduct clinical trials do so with years of specialized education and training under their belt, while most participants journey through the patient experience as laypeople. This disparity creates a mandate for the development of … Read More →

Bridging Preclinical and First-in-Human

It’s no surprise that mice are the standard subjects for preclinical research. They are real living things that have real reactions, both positive and negative, to drugs. They’re also not typically associated with the kind of emotional connection that occurs between humans and large pets like cats and dogs. In other ways, however, they are … Read More →

Challenges and Necessities in Respiratory Drug Development

As medical science progresses, our ability to control disease typically improves. Cancer mortality rates have steadily declined over the past 25 years. Not many people in the developed world die from the common flu anymore. Numerous diseases have been eradicated altogether, thanks to vaccines and improved treatment. In this regard, respiratory disease is something of … Read More →

What’s in Store for Zika Virus?

Last weekend, the 2016 summer Olympics wrapped up in Rio de Janeiro. Hundreds of thousands of people from around the world had descended on the city hoping to see the top athletes from their countries snag a gold medal or two to bring home. But as Simone Biles navigated the balance beam and Usain Bolt … Read More →