At the end of February, FDA released a final rule, entitled “Additional Safeguards for Children in Clinical Investigations of Food and Drug Administrated-Regulated Products.” The final rule says that FDA will not allow waivers of parental or guardian permission for...
The Clinical Trials Transformation Initiative (CTTI), a public-private organization created to improve the way clinical trials are conducted, established the Patient Leadership Council (PLC) to involve patient advocates in its objective. The 16 member council composed...
Numerous pharmaceuticals are approved and marketed based on the premise that they favorably change disease state-biomarkers. However, recent data has shown that altering the biomarkers indicative of disease does not necessarily translate to ameliorated health. In an...
One of the greatest challenges of clinical research is patient recruitment and retention according to Tufts Center for the Study of Drug Development (CSDD). To help clinical research professionals improve clinical trial management, Tufts CSDD analyzed more than 150...
The Tufts Center for the Study of Drug Development (CSDD) published its Outlook 2013 report on pharmaceutical trends. Although Tufts CSDD Director Kenneth I Kaitlin is optimistic about the future of dug innovation, he believes companies needs to identify and reduce...
The Annals of Internal Medicine published a guideline, entitled “The Standard Protocol Items: Recommendations for Interventional Trials” or SPIRIT 2013 to address the clinical practice quality issues surrounding current trials, as reported by an article on...
