CTTI

Meeting Agenda

Meeting Presentations:

Introduction to the Clinical Trials Transformation Initiative (CTTI) by Judith M. Kramer
Origin of the Project, "Use of Central IRBs for Multi-center Clinical Trials" by Jane Perlmutter*
Results of Literature Review by Devon Check*
Early Interviews with Experts by Kathryn Flynn*
Interviews to Obtain Feedback on Proposed Solutions - Rational for "Considerations Document" by Kevin Weinfurt*

*The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

The Use of Antibacterial Drugs Developed via Streamlined Approaches for Serious Infections Where There is Unmet Need: Understanding Patient and Physician Perspectives and Considerations to Take Forward

MARCH 01, 2016

CTTI Project: Unmet Need

Meeting Objectives

Present perspectives from patients, caregivers and physicians on antibacterial drugs developed using streamlined approaches
Identify focus group themes and discuss topics which should be further explored or where draft recommendations could be made
Obtain feedback to improve labeling, risk communication, public understanding and stewardship

Meeting Location:

Sheraton Silver Spring Hotel, Silver Spring, MD

Meeting Materials:

Meeting Presentations:

Introduction to the Clinical Trials Transformation Initiative and the ABDD Program by Pamela Tenaerts
Project Overview and Scope by Jamie Roberts
Current Landscape and Pipeline of Antibacterial Products by Vance Fowler
Streamlined Development Approaches by Joseph Toerner
Findings: Perspectives of Patients, Caregivers and Healthy People by Diane Bloom
Findings: Perspectives of Providers and Investigators by Thomas Holland
Focus Group Themes and Questions for Consideration by Stephen Mikita
Closing by Pamela Tenaerts, Rosemary Tiernan & Jamie Roberts

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Statistical Issues Think Tank II

NOVEMBER 19, 2014

CTTI Project: Unmet Need

Meeting Objectives

To provide an update on the current status of statistical methodologies for the design and analysis of antibacterial drugs
To discuss ongoing challenges in the development and adoption of innovative methods
To generate strategies to propel antibacterial drug development forward.

Meeting Location:

Bethesda North Marriott Hotel & Conference Center, Bethesda, MD

Meeting Materials:

Meeting Presentations:

Session 1: Current status of drug development and ongoing challenges

Introduction to CTTI's Clinical Trials Transformation Initiative: Antibacterial Drug Development Project by Lisa M. LaVange
Summary of Regulatory Standards and Guidances by Joseph Toerner
Summary of unmet need guidance and statistical challenges by Daniel B. Rubin
Application of Pharmacokinetics/Pharmacodynamics in New Anti-Infective Drug Development: Current Challenges and Future Perspectivesby Seong Jang
Statistical Considerations for Antibiotic Drug Development by Aaron Dane

Session 2: Current research and additional opportunities for the future

Discordant MIC Analysis: Testing for Superiority within a Non-inferiority Trial by Dean Follmann, Erica BriDain, and John Powers
Hierarchical nested trial design (HNTD) for new antibacterial drugs in patients with emerging bacterial resistance by Thamban Valappil and Mohammad Huque
Response Adjusted for Duration of Antibiotic Risk (RADAR) by Scott Evans
Some Proposals in the Analysis of Antibacterial Drug Trials by Margaret Gamalo-Siebers and Ram C. Tiwari

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Expert Meeting: IND Safety Assessment and Communication

FEBRUARY 28, 2012 TO FEBRUARY 29, 2012

CTTI Project: Safety Reporting

Meeting Background:

Since its inception, the Clinical Trials Transformation Initiative (CTTI) has had an interest in improving the quality and efficiency of safety reporting for serious adverse events (SAE) in studies performed under investigational new drug applications (INDs). CTTI’s first project on this topic focused on expedited safety reporting of serious, unexpected and possibly related SAEs to site investigators in multi-center trials. At the project’s conclusion, CTTI recommended that sponsors decrease the volume of uninterpretable and irrelevant safety reports to investigators, and instead supply investigators with meaningful reports that would improve investigators’ understanding of a drug’s benefit-risk profile. These recommendations were developed immediately prior to the FDA issuing a new final rule on safety reporting for drugs being studied under INDs.

FDA’s new IND safety reporting rule, published in the Federal Register on September 29, 2010, became effective on March 28, 2011. The intent of the new rule is to improve the quality of safety reports by minimizing the number of uninterpretable reports that sponsors submit to FDA and investigators. This is consistent with CTTI’s recommendations described above. However, CTTI members have expressed concern that there may be some uncertainty about the best methods to implement the new rule. For this reason, CTTI formed a new project entitled “IND Safety Assessment and Communication,” with the goal of promoting responsible oversight of safety for pre-market drug products consistent with the intent of the FDA’s new IND safety rule. The project objectives are as follows:

To obtain a deeper understanding of sponsors’ current practices for assessing safety of a pre-market drug product across all trials and sources of safety information and for communicating potential safety signals
To facilitate an informed discussion of practices and challenges in assessing and communicating IND safety information
To issue recommendations for future approaches that will support the intent of the IND safety reporting rule effective March 2011

The project team first surveyed industry sponsors to obtain a deeper understanding of their current practices. CTTI then distributed anonymized survey results to a group of experts that included representatives from each sponsor organization that completed the survey, government (NIH, Department of Veterans’ Affairs, and FDA), academia, and patient advocacy. These experts participated in a meeting convened on February 28-29, 2012 in Bethesda, MD. A subgroup of attendees at this meeting were members of a biostatistics workgroup that the CTTI project team formed to advise on the methodological dilemmas related to implementing the new IND Safety Reporting rule.

Meeting Objectives:

Findings from the survey of sponsor practices
Companies’ strategies for implementing the new IND safety reporting rule
Challenges in implementing the new rule

Meeting Location:

Bethesda, Maryland

Meeting Materials:

Expert Meeting: Adverse Event Reporting

OCTOBER 03, 2010 TO OCTOBER 04, 2010

CTTI Project: Safety Reporting

Meeting Background:

The key objectives of this expert meeting included:

Discuss and integrate empirical findings from all components of this project
Consider implications of the FDA’s new safety regulations
Develop a set of recommendations for optimal reporting of unexpected serious adverse events to investigators that will improve human subject protection

Meeting Location:

Marriott Inn & Conference Center, Hyattsville, MD

Meeting Materials:

Meeting Presentations:

Day 1

Welcome, Introductions, and Meeting Objectives by Judith Kramer, CTTI
SAE Project Overview by Jose Vega, Amgen
Current Practices – Workstream 1 Summary of Findings by Sundeep Sethi, Amgen
Investigator Time and Perceived Value – Workstream 2 Summary of Findings by Howard Greenberg, ACCP
Comparison of Alternative Models – Workstream 3 Summary of Findings by Lynda Szczech, Duke University
Patient Perspectives – Workstream 4 Summary of Findings by Kevin Weinfurt, Duke University
Summary of Findings from All Workstreams and Goal for October 4th Meeting by Judith Kramer, CTTI

Day 2

Recap of Important Findings and Recommendations from Workstreams 1–4 by Judith Kramer, CTTI
Highlights of New FDA Rule on Premarketing Safety Reporting Issued on September 28, 2010 by Janet Norden, Office of Medical Policy, CDER, FDA

Meeting Results:

On September 29, 2010—just prior to the expert meeting—the FDA issued a new final rule and accompanying draft guidance concerning IND safety reporting. The requirements of the new safety rule, which went into effect on March 28, 2011, affected interpretation of the project findings described above. Meeting participants acknowledged that the new FDA rule marked a major step forward in recognizing that little knowledge can be gained from an individual event. Participants also agreed that inundating investigators with such data is inefficient and ineffective and that the FDA rule and guidance hold promise for helping to eliminate this burden on investigators. The discussion revealed, however, that implementation of the rule could pose challenges that may only be resolved through the concerted educational efforts and international harmonization of regulatory expectations.

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Expert Meeting: CTTI IND Safety Advancement Project

JULY 21, 2015 TO JULY 22, 2015

CTTI Project: Safety Reporting

Meeting Objectives

Present findings and conclusions from the project evidence gathering activities
Discuss opportunities for improving the efficiency and value of the expedited IND safety reporting process
Understand opportunities for educating stakeholders on expedited IND safety reporting best practices

Meeting Location:

DoubleTree by Hilton Hotel Washington, D.C., Silver Spring, MD

Meeting Materials:

Meeting Presentations:

Click here to view the presentation slides from this meeting.

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

CTTI Data Monitoring Committees Project Expert Meeting

JULY 28, 2015 TO JULY 29, 2015

CTTI Project: Data Monitoring Committees (DMCs)

Meeting Objectives

Present findings and conclusions from the project survey and focus groups
Share and solicit feedback on proposed Data Monitoring Committees (DMCs) recommendations

Meeting Location:

DoubleTree by Hilton Hotel Washington, D.C., Silver Spring, MD

Meeting Materials:

Meeting Presentations:

Click here to view the presentation slides from this meeting.

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

Are You Ready for Mandated Single IRB Review for Multicenter Clinical Trials?

NOVEMBER 14, 2017

CTTI Project: Single IRB

Meeting Objectives:

Review upcoming NIH policy and Common Rule changes regarding single IRB review as well as existing FDA Guidance on Centralized IRB Review Process in Multicenter Clinical Trials.
Discuss the remaining gaps in knowledge, guidance and tools for implementing a single IRB review model.
Propose solutions regarding implementation of single IRB model for federally funded (e.g., NIH-sponsored), and for FDA-regulated drug and device, multicenter clinical studies.

Meeting Location:

DoubleTree by Hilton Hotel Silver Spring, 8727 Colesville Rd., Silver Spring, MD

Meeting Materials:

Meeting Presentations:

Introduction to CTTI and the Single IRB Project by Sara Calvert
NIH Single IRB Policy by Petrice Brown-Longenecker
Changes to the Common Rule for Single IRB by Lyn Lau
FDA Guidance on Centralized IRB Review Process in Multicenter Clinical Trials by Bridget Foltz
Resources from the CTTI Single IRB Projects by Cynthia Hahn
SMART IRB Platform Overview by Petra Kaufmann
SMART IRB Exchange NIH Trial Innovation Network by Emily Serdoz
AAHRPP Proposed Single IRB Review Standard by Robert Hood

The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.

CTTI Antibacterial Drug Development: Statistical Issues Think Tank Meeting

AUGUST 20, 2012

CTTI Project: Unmet Need

Meeting Background:

A CTTI-hosted Statistical Issues Think Tank Meeting was convened to provide an opportunity for leading experts in clinical trial methodologies to discuss alternative approaches to design and analysis that may be useful for antibacterial drug development programs.

Meeting Location:

Bethesda Hyatt Regency, Bethesda, MD

Meeting Materials: