CTTI

Meeting Presentations:

Welcome and Background by Annemarie Forrest
Keynote Presentation by John Wilbanks
Findings from the MCT Stakeholder Perceptions Survey of Potential Clinical Trial Participants by Angie Botto-van Bemden, Cindy Geoghegan, and Les Jordan
Key Considerations for Patient Engagement in Clinical Trials by Suzanne Schrandt
Ethical and Privacy Considerations of Mobile Technology by Camille Nebeker
Findings from MCT Stakeholder Perceptions Investigator Interviews by Bill Wood

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.

Qualifying Investigators to Conduct Sponsored Clinical Trials

DECEMBER 13, 2017 TO DECEMBER 14, 2017

CTTI Project: Investigator Qualification

Meeting Objectives:

Report evidence gathered on:
- Critical tasks associated with clinical investigators’ conduct of clinical trials.
- Gaps and redundancies in training for preparing clinical investigators to conduct clinical trials.
- Suggested knowledge and skills necessary for the quality conduct of clinical trials.
Evaluate proposed framework of characteristics within control of clinical investigator sites that define the quality conduct of a clinical trial.
Discuss how preparing clinical investigators for the quality conduct of a clinical trial could be optimized.
Identify the recommendations and tools that sponsors and investigators could implement to better prepare clinical investigators for the quality conduct of a clinical trial. Also, pinpoint the barriers—and solutions—to implementing these recommendations.

Meeting Location:

Hyatt Regency Bethesda 1 Bethesda Metro Center, Bethesda, MD 20814

Meeting Materials:

Meeting Presentations:

Welcome and Review of Aligned CTTI Work by Annemarie Forrest
The CTTI Investigator Qualification Project and Meeting Goals by Jennifer Goldsack
A Changing Ecosystem – A Brief Review of ICH GCP Renovations Planned and Currently Under Way by Theresa Mullin
Proposed Framework of Characteristics that Define the Quality Conduct of a Clinical Trial by Janette Panhuis
Evidence Gathering: Our Approach to Data Collection by Teri Swezey
Critical Tasks that our Evidence Suggests Should be Well Executed to Drive the Quality Conduct of a Clinical Trial by David Ciavarella
Perceived Risks to the Quality Conduct of Clinical Trials by Kate Haratonik
Knowledge and Skills our Evidence Suggests may be Needed to Perform Critical Tasks and Mitigate Risks to Quality Trial Conduct by Catherine Dillion
Evaluating Current Approaches to Preparing Investigators and Their Delegates by Patricia Hurley
Building a Learning Ecosystem by Tina Chuck
Case Study of an Investigator Mentoring Program by Emily Lemons
Delivering Effective Training to Investigators and Their Delegates by Tina Chuck
An Investigator's Reflections on Training by Christine Hildebrand
FDA's Perspective on GCP Training by Bridget Foltz

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.

Scientific and Technological Issues Surrounding the Use of Mobile Devices in Clinical Trials

JUNE 15, 2017 TO JUNE 16, 2017

CTTI Project: Digital Health Trials

Meeting Objectives

Present findings from evidence gathering activities
Discuss how this evidence may be used to provide direction for the appropriate utilization of mobile devices for objective data capture in clinical trials. Specifically,
- possible solutions to key data challenges
- scientific and technological considerations
Identify the change agents who will drive adoption of mobile devices for capturing objective data in clinical trials, including for the purposes of regulatory submission
Describe what products CTTI should develop to equip change agents to include mobile devices for data capture in clinical trials, including for the purposes of regulatory submission

Meeting Location:

DoubleTree by Hilton Hotel Crystal City 300 Army Navy Drive | Arlington, VA

Meeting Materials:

Meeting Presentations:

1. The CTTI MCT Mobile Devices Project and Meeting Goals by Jennifer Goldsack
2. Human Adaptation to Information: A Challenge for the Next Decade by Robert Califf
3. Mobile Clinical Trials and CDRH's Regulation of Devices by Dharmesh Patel
4. Recommendations from CTTI’s MCT Novel Endpoints Project by Jennifer Goldsack
5. Presentation of Evidence on Data Challenges (Panel Presentation)
6. Presentation of Evidence on Scientific and Technological Issues (Panel Presentation)

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.

Optimizing Operational Efficiencies for Data Collection in HABP/VABP Trials

NOVEMBER 12, 2013

CTTI Project: Streamlining HABP/VABP Trials

Meeting Background:

The goal of this meeting is to seek practical solutions to streamline the operational processes and build efficiencies for data collection in HABP/VABP trials.

Meeting Location:

Arlington, Virginia

Meeting Materials:

Meeting Presentations:

Introduction by Pamela Tenaerts

Session 1: Challenges in data collection for HABP/VABP trials

Session 1 Goal: Understanding the issues surrounding data collection in HABP/VABP trials

Session 1 Focus: Why reducing excessive non-critical data collection in HABP/VABP trials would improve data quality, and benefit investigators, sponsors, reviewers, and patients

Can we reduce complexity and safety data collection to improve the quality of the data and inferences we make? by Charles Knirsch
Challenges in data collection for HABP/VABP trials: Investigator’s perspective by Richard Wunderink
Data Collection in HABP/VABP Trials: Regulatory Perspective by Sumati Nambiar

Session 2: Regulatory requirements for AE data collection in registration trials

Session 2 Goal: Discuss different regulatory requirements and the challenges of meeting these requirements for data collection for HABP/VABP registration trials that are globally conducted, and evaluate whether future work is needed to harmonize approach to AE collection

Session 2 Focus: AE collection and adjudication of relatedness and seriousness; Reporting of SAE’s and SUSARS and evaluation

Safety data collection in late stage premarket and post-approval clinical investigations by Patrick Archdeacon
Managing safety data in multi-regional trials by Chris Wohlberg

Session 3: Strategies to simplify data collection using a QbD approach

Session 3 Goal: To simplify the recording, monitoring, and review to make HABP/VABP trials more feasible and economical

Session 3 Focus: Reduction in the amount of data collected by identifying data that are critical to quality and those that may be essential to determine the benefit/risk of the treatment for registration, and those may be less informative

Using QbD for data collection planning by Mark Behm
Guiding principles for efficient data collection- 20 years of cardiovascular outcomes trials by Lisa G. Berdan
Breakout discussion instructions by Sabrina Comic-Savic

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.

Strengthening the Investigator Community Project

APRIL 05, 2017

CTTI Project: Investigator Community

Meeting Objectives

Present findings from CTTI’s Strengthening the Investigator Site Community Project: Expert Interviews and Survey
Receive feedback on identified challenges experienced by principal investigators and strategies to overcome these challenges
Identify essential elements necessary to strengthen and grow the community of productive, experienced site investigators
Develop strategies and best practices to promote the growth and strengthening of the community of experienced site investigators
Identify barriers to strategy implementation and propose solutions

Meeting Location:

Sheraton Silver Spring Hotel 8777 Georgia Ave., Silver Spring, MD

Meeting Materials:

Meeting Presentations:

1. Issue, Project Overview, and Meeting Objectives by Diana Foster
2. One and Done Survey Design and Findings by Christopher Fordyce
3. Active Investigator Interview Findings by Terri Hinkley Key
4. Elements for Site Investigator Success by Matthew Roe
5. Fiscal Responsibility and Discipline by Kaitlin Malone
6. Optimizing Trial Execution and Conduct by Robin Douglas
7. Investigator Perspective: My Approach / Why Do I Remain Involved? by David Whellan
8. PCORnet by Matthew Roe
9. A Primer in FDA Resources for Clinical Investigators by Bridget Foltz
10. FDA Observations Related to Investigator Participation by David Burrow

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.

Meeting on the Long-Term Safety and Efficacy of Extended-Release and Long-Acting Opioid Analgesics for Chronic Pain

AUGUST 12, 2013 TO AUGUST 13, 2013

Meeting Background:

The purpose of this meeting, hosted by CTTI, is to facilitate a broad scientific discussion about optimal ways to generate additional evidence to help inform the safe and effective use of extended-release and long-acting opioid analgesics.

Meeting Objectives:

Engage multiple stakeholders in discussions around approaches to develop more evidence on the long-term safety and efficacy of extended-release and long-acting opioid analgesics for the treatment of chronic non-cancer pain
Review and discuss a proposed study to evaluate the long-term efficacy of opioids for the treatment of chronic non-cancer pain
Discuss strategies to assess the long-term safety of extended-release and long-acting opioid analgesics for the treatment of chronic non-cancer pain

Meeting Location:

Sheraton Silver Spring Hotel, Silver Spring, MD

Meeting Materials:

Meeting Presentations:

Welcoming Remarks by Pamela Tenaerts and Rachel Sherman

Session 1: Evidence for the Efficacy of Opioid Analgesics for Chronic Pain

Review of the Evidence for the Efficacy and Effectiveness of Opioid Analgesics for Chronic Pain by Jane Ballantyne

Session 2: Review of Proposed Efficacy Study

Overview of Efficacy Protocol Synopsis by Robert Califf
Proposed Protocol Synopsis (PDF)

Session 3: Continued Discussion of Efficacy Study

Session 4: Existing Data Sources to Evaluate Opioid Analgesic Safety

Monitoring Opioid Analgesic Abuse and Overdose in the United States by Christopher M. Jones
Postmarketing Surveillance of Prescription Drug Abuse by Richard Dart
Harnessing National Data Sets: National Survey on Drug Use and Health (NSDUH) and VA Data by William Becker
Using Integrated Health Plan EMR Data to Evaluate Outcomes Associated with Clinical Services for the Treatment of Non-Malignant Chronic Pain by Lynn DeBar

Session 5: Gathering Additional Evidence on Opioid Analgesic Safety

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.

Pregnancy Testing in Clinical Trials Expert Meeting

JULY 15, 2013 TO JULY 16, 2013

CTTI Project: Pregnancy Testing

Meeting Background:

Designing a pregnancy testing protocol for a clinical trial requires balancing the performance characteristics of a given test, the baseline risk of pregnancy in a given subject population, the potential risks to the fetus from study interventions, and the effect of the testing protocol on overall study implementation in terms of burden to subjects, burden on staff, and direct costs. There are no published data on the consistency of sponsors, investigators, or institutional review boards (IRBs) in applying these criteria to designing and evaluating pregnancy testing protocols. However, anecdotal reports indicate that there is widespread variability.

Development of evidence-based guidance that explicitly considers the level of acceptable risk to suggest appropriate pregnancy testing protocols will ultimately improve protection of research subjects, reduce the risk of unintended fetal exposure, and reduce the workload of sponsors, investigators, IRBs, and other stakeholders in the clinical trial enterprise.

Meeting Objectives:

Present survey findings and computer simulation model results from the CTTI project entitled, Developing Rational Guidance for Pregnancy Testing in Clinical Trials
Discuss practices and challenges in assessing the acceptable risk of pregnancy and implementing a pregnancy testing protocol for a clinical trial
Solicit additional feedback and develop consensus on factors to consider when assessing acceptable risk of pregnancy in clinical trials

Meeting Location:

DoubleTree by Hilton Hotel, Bethesda, MD

Meeting Materials: