Clinical Research Management Briefing - November 20, 2017
President Trump nominated Alex M. Azar II, a former president of Eli Lilly’s American division and previous Department of Health and Human Services employee, to oversee the federal agency.
The New York Times, November 13
A new study to assess the efficacy of U.S. Food and Drug Administration regulations found sufficient levels of female participation in clinical drug trials, but a need for broader inclusion of racial minorities.
EurekAlert!, November 7
The FDA is taking steps to address the issue that 60 percent of drugs used in children are not approved for pediatric use and 90 percent of drugs are unapproved for neonatal use.
FDA.gov, November 9
The number of data sources used in clinical trials is projected to double over the next three years, forcing companies to improve their data management platforms and processes.
The Association of Clinical Research Professionals, November 13
The rise of electronic data capture technologies on patients’ personal devices can mitigate the burden of paper-based data entry and amplify the patient voice in healthcare decision-making.
Applied Clinical Trials, November 9
Product commercialization, widely publicized patent disputes and misconceptions around the risk and reward of certain procedures may contribute to consumers’ attitude toward the biotech sector.
MedCity News, November 13
Most existing clinical trial standards emphasize protocols and data, but not program design. The Clinical Development Design (CDD) Framework aims to fill that gap.
Applied Clinical Trials, November 9Contact Us