1990, April – ICH was first formed during a meeting, held by the EFPIA in Brussels, in 1990. Representatives of the regulatory agencies and industry associations of Europe, Japan, and the United States met, primarily, to plan an International Conference.
1991– The adoption of final version of " common rule" governing protection of human subjects for research sponsored by all federal agencies
1992 – PDUFA, the first FDA user fee program.
1993 – Second ICH Conference in Orlando.
1996 – Third ICH Conference in Yokohama.
1996 – Congress enacts HIPAA (Health Insurance Portabiality & Accountability Act) with provisions regarding privacy of human medical records.
1996-ICH GCP Guideline finalized
1997– FDAMA-pediatric studies & incentives (expanded under 2003 Pediatric Research Equity Act); clinicaltrials.gov, fast track approvals
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
The Rise of Predictive Engagement Tools in Clinical Trials
November 22nd 2024Patient attrition can be a significant barrier to the success of a randomized controlled trial (RCT). Today, with the help of AI-powered predictive engagement tools, clinical study managers are finding ways to proactively reduce attrition rates in RCTs, and increase the effectiveness of their trial. In this guide, we look at the role AI-powered patient engagement tools play in clinical research, from the problems they’re being used to solve to the areas and indications in which they’re being deployed.