In the wake of the recent commotion surrounding flawed research at Duke University on diagnostic tools based on molecular patterns (“omics” tests), an Institute of Medicine (IOM) panel has issued a report entitled Evolution of Translational Omics: Lessons Learned and...
In February, FDA released a new guidance document entitled “Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c)”. The purpose of the guidance is to help small businesses, particularly clinical trial sponsors, investigators, and institutional review...
Several sources have recently pointed to possible links between poor patient adherence during clinical drug trials and unexpected adverse effects—as well as personal injury cases—once the drug is approved and marketed. Chief among these sources is the Consumer Health...
A report released Feb. 29th by the Institute of Medicine (IOM) provided a review of the benefits of current federal laws that offer incentives for or require drug and biologic developers to conduct pediatric studies. The report also highlighted several areas where...
Check out what our friend and colleague Christine Pierre had to say in this February 21, 2012 article by Ann Neuer of bioitworld.com. Christine gave her thoughts on the current budget woes that exist within the clinical trial process. As she shares, budgets are...
NIH has launched a new website to increase public awareness for clinical trials. Click here to view the site. Research has shown that the lack of general knowledge about clinical trials is one of the biggest challenges in recruiting study volunteers. The website...
