Tag Archives: CTTI

CTTI Releases 2015 Annual Report

Clinical trials, Informed Consent, Patient engagement, , , , , , , ,

The Clinical Trials Transformation Initiative (CTTI) has released its Annual Report for 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.

Cover page of CTTI Annual Report with embedded link to CTTI webpage containing report.
2015 CTTI Annual Report

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.

 

Upcoming CTTI Webinar on Informed Consent Recommendations

Informed Consent, Regulatory issues, , , ,

CTTI-logo-127x100The 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 Meeting 
Meeting 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)

ClinicalTrials.gov Analysis Dataset Available from CTTI

Clinical trials, Data quality, Data sharing, Policy, Regulatory issues, Research reporting standards, Research tools, , , ,

Tools for ResearchAs 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.

CTSA Working Group Unveils Accelerated Clinical Trial Agreement

Clinical trials, Regulatory issues, Research tools, , , , , ,

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.

However, the Clinical and Translational Science Award (CTSA) Master Contracts Working Group has recently developed a possible solution—the Accelerated Clinical Trial Agreement, or ACTA. The ACTA provides a standardized template for contracts between site investigators and study sponsors, one with the potential to expedite contracting and make the start-up process for clinical trials more efficient.

The ACTA, which has already been adopted by more than 50 research centers and individual is available, along with the Accelerated Confidential Disclosure Agreement (ACDA), from the CTSA’s Accelerated Research Agreements Initiative.

For further reading:

CTSA Tools - ACTA

"Use Accelerated Clinical Trial Agreement (ACTA) to Expedite Study Start-Up" (Duke Translational Medicine Institute)

Clinical Trials Transformation Initiative - Site Metrics Project Summary

Cycle time metrics for multisite clinical trials in the United States

CTTI Releases New Tools to Help Organizations Implement Central IRBs

Institutional review boards,

The Clinical Trials Transformation Initiative (CTTI) has released new recommendations encouraging adoption of a central institutional review board (IRB) model for multicenter clinical trials. The recommendations are based on results from its Central IRB Advancement Project. Along with the recommendations, CTTI offers tools, including evaluation checklists and an IRB authorization agreement template, to help organizations implement a central IRB model.

Read the complete announcement on the CTTI blog.

Developing Approaches to Conducting Randomized Trials Using Mini-Sentinel: Webinar and White Paper

Pragmatic clinical trials, , ,

A recent webinar (see recording) covered a collaborative effort of the Clinical Trials Transformation Initiative (CTTI) and the FDA Mini-Sentinel project in which investigators are exploring the possibility of using the Mini-Sentinel distributed database infrastructure to conduct randomized, multicenter clinical trials. Speakers Richard Platt, MD, MS, of Harvard Pilgrim Health Care Institute, and Patrick Archdeacon, MD, of the FDA, summarized the work and discussed next steps that will continue to advance the project.

A white paper published earlier this year, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database, describes the results of the investigator analysis in greater detail. The white paper is the product of the CTTI Uses of Electronic Data project.

Grand Rounds (4-25-2014): CTTI’s Central IRB Advancement Project

Pragmatic clinical trials, Regulatory issues, , , ,

Update:

Archived video and slides from the April 25 Grand Rounds are now available on the NIH Collaboratory Grand Rounds webpage.

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 Hahn and 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.