The Clinical Trials Transformation Initiative (CTTI) has released its Annual Reportfor 2015. The report describes major achievements from the previous year, including new recommendations and related tools and checklists for improving the safety, efficiency, and overall quality of clinical research.
Highlights of the 2015 Annual Report include recommendations on topics including:
Ethics review processes
Good Clinical Practice training for trial investigators
Research protocol design
Engagement of patient groups as equal partners in clinical research
Informed consent processes
Safety reporting systems for research participants
A public-private partnership whose many stakeholders include government agencies, advocacy groups, professional societies, academic research organizations, and representatives from the medical products industry, CTTI’s mission is to “identify and promote practices that will increase the quality and efficiency of clinical trials.”
A PDF version of the report is available here. Previous Annual Reports are also available on the CTTI website.
The Clinical Trials Transformation Initiative’s Informed Consent Project will unveil recommendations and associated resources for informed consent on Thursday, November 19.
Presenters include Jennifer Lentz, Global Informed Consent Process Owner in Global Clinical Operations at Eli Lilly and Company, and Michele Kennett, Assistant Vice Chancellor for Research and Director of the Institutional Review Board at the University of Missouri.
• Topic: Informed Consent Project Recommendations • Date: Thursday, November 19, 2015 • Time: 12 – 1 pm EST
To join the public webinar:Meeting Link: Join WebEx MeetingMeeting Number: 732 884 847 Meeting Password: ctti
After you connect to the website, please follow step-by-step instructions for connecting to the audio. If you prefer to connect to audio only, you can join by phone at:
1-855-244-8681 Call-in toll-free number (US/Canada) 1-650-479-3207 Call-in toll number (US/Canada)
As part of a project that examined the degree to which sponsors of clinical research are complying with federal requirements for the reporting of clinical trial results, the Clinical Trials Transformation Initiative (CTTI) and the authors of the study are making the primary dataset used in the analysis available to the public. The full analysis dataset, study variables, and data definitions are available as Excel worksheets from the CTTI website and on the Living Textbook’s Tools for Research page.
A persistent problem facing the clinical research enterprise is the difficulty of negotiating the terms of contracts under which clinical trials will be performed at individual clinical research sites. For many research centers, the process is complex and protracted, and can often contribute to substantial delay in study start-up.
This Friday’s NIH Collaboratory and PCORnet Grand Rounds (“CTTI Advancing the Use of Central IRBs Project: Academic Institution and Government Sponsor Perspectives”) will be presented by Cynthia Hahnand Petra Kaufmann, MD, MSc, team leaders for the Clinical Trials Transformation Initiative’s Central IRB Advancement Project. Ms. Hahn is vice president of Clinical Research & Regulatory Affairs for the Feinstein Institute for Medical Research. Dr. Kaufmann is director of the Office of Clinical Research for the National Institute of Neurological Disorders and Stroke.
CTTI’s Central IRB Advancement Project is a follow-up to its previous Central IRB Project that conducted expert and stakeholder interviews to produce considerations and recommendations for central IRB adoption. The current project will take additional steps in encouraging the implementation of these recommendations and addressing remaining barriers to further advance the use of central IRBs for multicenter clinical trials. Expected deliverables include tools and best practices for researchers, sponsors, sites, and IRBs.
The Grand Rounds presentation will take place from 1:00-2:00 PM Eastern time on Friday, April 25. Details are available here. Archived video and slides from the presentation will be available early the following week; links to archived material will be provided in an update to this post.