PPT-Ensuring quality in clinical trials

Monitoring concepts and CRC development training Amelia Spinrad MS 18 Eunjoo Pacifici PharmD PhD Nancy PireSmerkanich DRSc MS USC SouthernCalifornia Clinical and Translational Sciences Institute . Cynthia M. Otto, DVM, PhD DACVECC. Associate Professor of Critical Care. What is a clinical trial?. A prospective evaluation in which the factor of interest is controlled by the investigator. RANDOMIZATION. UKCRC CTU Registration. Presented by Professor . Julia Brown. UKCRC . Registered CTU Network . CTU Workshop, . January 2012. . . . Unprecedented investment in clinical research in recent years - expansion in UK clinical trials portfolio. CLINICAL TRIALS IN THE TWENTY-FIRST CENTURY: ONGOING CHALLENGES AND EMERGING ISSUES Susan S. Ellenberg , Ph.D. University of Pennsylvania SCT/ICTMC Joint Meeting Liverpool, UK May 8, 2017 CLINICAL TRIALS TIMELINE Industry and CRO Perspective on Clinical Trial Quality David J. Hewitt Vice President of Medical and Scientific Affairs Vice President and Global Head MSA Neurology and Pain IMMPACT June 2015 Currently working for inVentiv Health a CRO/CCO Virginia A. Caine, M.D.. Associate Professor of Medicine. Division of Infectious Diseases. Indiana University School of Medicine. Director, Marion County Public Health Department. Indianapolis, Indiana. Dartmouth CO-OP PBRN. January 26, 2020. ECHO. (Environmental influences on Childhood Health Outcomes) - . Mission & Vision. “To enhance the health of children for. generations to come (through)…”. Professor John . Simes. Director, NHMRC Clinical Trials Centre. Goals. Generate high quality evidence of the effectiveness of . health care interventions through . randomised. trials . Be a national resource in design, conduct analyses and. Ashley E. Ross MD PhD. Executive Medical Director. Mary Crowley Cancer Research Centers. NASPCC Annual Meeting 2019. Objectives. Define GCP (Good Clinical Practice) and its applications for patients and research.. Professor Julia . Brown. Leeds Institute of Clinical Trials Research, University of Leeds. Introduction. First clinical trial in 1747, James Lind. Clinical trials are gold standard for the evaluation of new treatments/interventions in health care . Clinical trials . are required in the development of . new . medicines and improved treatments . for . patients. . The . information that clinical trials generate on the efficacy and safety of . treatments . Public-Private Partnership. Co-founded by Duke University & FDA . Involves all stakeholders. Approx. 80+ members. Participation of 400+ more orgs. MISSION: To develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. Research. NHMRC CTC . 30th . Anniversary . S. ymposium . 1 March 2019. The future of clinical trial funding. Professor Anne Kelso AO Chief Executive Officer. Clinical trials funding in NHMRC’s new grant program. Helen Hill. Senior Regional Advisor Clinical Trials . hhill. @liv.ac.uk. www.ctrc.org.uk. . Specialist. . units . to . design, conduct, analyse and publish clinical trials and other well-designed studies. . Covered in this presentation. Basic information about clinical trials. Information about finding a clinical trial. Information about participating in or leaving a clinical trial . Vision. Mission. Make Ontario a preferred location for global clinical trials, while maintaining the highest ethical standards..