Lorri Bingham, Author at CTTI

CTTI Presents Results of Several Projects at Society for Clinical Trials 36th Annual Meeting

Posted on May 11, 2016August 12, 2021 by Lorri Bingham

On May 17 – 20, 2015, the Society for Clinical Trials will host its 36th Annual Meeting in Arlington, VA. An international community of professionals from a variety of disciplines will gather for three days of workshops, presentations, and discussions on the design, conduct, and analysis of clinical trials. CTTI will participate in several events throughout this conference and we look forward to discussing a number of practices that will increase the quality and efficiency of clinical trials.

Presentation: Making Trials Better: CTTI Recommendations for Developing Protocols and Identifying Safety Signals (Invited Session 8)
Date: May 18, 2015 from 12:45 – 2:15 PM
Presenters: Pamela Tenaerts (CTTI), Martin Landray (Oxford), Nancy Roach (Patient Representative), Janet Wittes (Chair of CTTI Biostatistics Workgroup)

Presentation: CTTI Recommendations for Developing Clinical Trials Pregnancy Testing Plans (Topic Contributed Session 3)
Date: May 18, 2015 from 2:45 – 3:45 PM
Presenters: Sara Calvert, Organizer (CTTI), Evan Myers (Duke University), Claire Jurkowski (Bristol Myers Squibb), Melissa Tassinari (FDA/CDER)

Presentation: Improving the Clinical Trial Process through Effective Engagement – Perspectives from the NIH, CTTI, PCORI, and Patient Advocacy Foundations (Invited Session 12)
Date: May 18, 2015 from 4:00 – 5:30 PM
Presenters: Megan O’Boyle (Phelan McDermid Syndrome Foundation), Bray Patrick-Lake (CTTI), Jamie Roberts (CTTI), Jaya Bea Smalley (PCORI), Veronica Todaro (Parkinson’s Disease Foundation)

Presentation: The Clinical Trials Transformation Initiative Data Monitoring Committee Project: Findings And Next Steps (Invited Session 27)
Date: May 20, 2015 from 9:15 – 10:45 AM
Presenters: Annemarie Forrest, Organizer (CTTI), Patrick Archdeacon (FDA), Ray Bain (Merck), Karim Calis (FDA)

Presentation: Trial Forge: A Systematic Approach to Making Trials More Efficient (Session 30)
Date: May 20, 2015 from 11:00 AM – 12:30 PM
Presenters: Peter Bower (University of Manchester), Marion Campbell (University of Aberdeen), Kerry Hood (University of Cardiff), Jamie Roberts (CTTI), Mary Foulkes, Discussant (George Washington University), Shaun Treweek, Organizer (University of Aberdeen)

CTTI Presents on Patient & Provider Attitudes on Streamlined Antibacterial Drug Development at ATS 2016

Posted on May 11, 2016August 12, 2021 by Lorri Bingham

Resistance to available antibiotics is increasing. Despite the critical need for novel antibacterial therapies, their development is lagging. At the 2016 American Thoracic Society (ATS) International Conference, Deborah Collyar, a project team member for CTTI’s Unmet Need in Antibiotic Development Project, will present results from interviews and focus groups on patient and provider attitudes toward using streamlined approaches for antibacterial drug development. These findings will be used to develop recommendations to improve the uptake and appropriate use of antibacterial therapies that are developed through streamlined approaches to address the critical unmet need for novel antibacterial therapies.

View the poster abstract.

If you are attending the conference, please stop by to learn more:

ATS 2016 International Conference Conference
Location: San Francisco, California
Poster: Streamlining Antibacterial Drug Development Programs to Address Unmet Medical Need: Patient and Provider Attitudes on a Modified Benefit-Risk Calculus
Date & Time: Sunday, May 15, 2016, from 9:00 AM-4:15 PM PT
Presenter: Deborah Collyar

CTTI Recommendations for Data Monitoring Committees to be Unveiled at the Society for Clinical Trials (SCT) Annual

Posted on May 9, 2016March 10, 2025 by Lorri Bingham

Data Monitoring Committees (DMCs) play a critical role in clinical trial conduct; however, the definition and role of a DMC are often misunderstood, even among stakeholders in the clinical trial enterprise. CTTI recommends that DMCs should be used when there is a need to periodically review the accumulating unmasked safety and efficacy data by treatment group, and advise the trial sponsor on whether to continue, modify, or terminate a trial based on benefit-risk assessment. Jane Perlmutter, patient advocate and team leader for the DMC Project, elaborates on this central theme of CTTI’s DMC recommendations:

“DMCs are something most clinical trial participants are unaware of. Yet, once a trial is approved by an IRB, DMCs are an important way to ensure that trials are proceeding in an orderly and ethical way and that the accumulating data do not suggest that the trial poses undue harm to patients.”

Given this important role of the DMC, it is imperative that they function optimally. The conduct of the DMC is largely dictated by a charter, which outlines the roles, responsibilities, and operational structure of the DMC, and should be agreed to by the sponsor and the DMC members prior to patient enrollment. Knowledge and experience of DMC members are other critical factors. New members would benefit greatly from apprenticeship or mentoring, as well as provision of case studies that illustrate challenging DMC scenarios.

The above-mentioned insights are just the beginning of a thorough examination on best practices for DMCs. CTTI’s full recommendations will be unveiled at this year’s Society for Clinical Trials (SCT) meeting. Join us for Invited Session 3 on Monday, May 16, where speakers Karim Calis, Raymond Bain, and Annemarie Forrest will reveal our recommendations. Dr. David DeMets, one of the thought leaders within the field of DMCs, will be the chair for this session. Following the unveiling, we hope you share Jane’s sentiments on the impact of our work:

“CTTI’s guidelines will help trial sponsors to follow best practices in regard to DMCs and also spur stakeholders to take measures to engage an adequate supply of diverse DMC members.”

Improve Clinical Trial Recruitment: Join Us for a Webinar Unveiling CTTI’s New Recommendations & Tools

Posted on May 4, 2016July 9, 2021 by Lorri Bingham

Patient recruitment is a leading challenge in the efficient completion of clinical trials, with as many as 40% of clinical trials failing to meet recruitment goals. Too often, recruitment planning is an afterthought in clinical trial development, leading to increased costs and delays in bringing new therapies to market.

After reviewing evidence on obstacles and approaches to clinical trial recruitment, CTTI’s multi-stakeholder Recruitment Project team has developed new recommendations and tools to improve recruitment across the clinical trial enterprise.

Please join CTTI for an informational webinar on May 19, 2016, from 12:00 – 1:00 p.m. EST (GMT-04:00), to review these recommendations and tools developed to help clinical trialists meet their patient recruitment goals. In this session, patient recruitment managers, program and portfolio directors, clinical trial sponsors and designers, and clinical investigators can learn more about:

A holistic approach that integrates strategic recruitment planning throughout the entire clinical trial process, beginning with study design and development
Ways to identify and engage all relevant stakeholders throughout recruitment planning to prevent downstream recruitment challenges
Recommendations for trial feasibility, site selection, and developing strategic recruitment communication plans
New tools available to aid in strategic recruitment planning

The webinar is open to the public, and we encourage you to share this invitation with your colleagues in the clinical trials enterprise.

Webinar Title: CTTI Presents Recommendations for Recruitment: Moving Recruitment Planning Upstream to Reduce Barriers

Date & Time: Thursday, May 19, 2016, from from 12:00 – 1:00 p.m. EST (GMT-04:00)

Speakers:

Jonca Bull, MD, Director, Office of Minority Health, US Food and Drug Administration
Elizabeth Mahon, JD, Associate Director Global Clinical Operations â€“ US, Janssen R&D

Webinar Login: CLICK HERE to enter meeting.

*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)

CTTI Reveals Findings from Pediatric Antibiotic Trials Project at PAS 2016

Posted on April 27, 2016March 10, 2025 by Lorri Bingham

Conducting antibacterial trials in pediatric populations has unique challenges, which have contributed to the overall complexity of antibacterial drug development. CTTI’s Pediatric Antibiotic Trials Project aims to identify barriers related to scientific and operational issues in the design and conduct of clinical trials of antibacterial drugs for children, as well as develop recommendations to address these challenges.

After conducting surveys with investigators of pediatric antibiotic clinical trials and community providers, conducting qualitative interviews with parents and industry representatives, and reviewing information in the ClinicalTrials.gov database, we now have a body of evidence to inform this discussion. Findings indicate a multiplicity of real and perceived modifiable barriers to participating in or conducting pediatric antibacterial clinical trials, the need for deeper engagement with parents, and the necessity of effective recommendations to improve the design and conduct of these trials. These findings will be presented at the Pediatric Academic Societies (PAS) 2016 Meeting in Baltimore, MD on April 30 – May 3, 2016.

Poster Topic: Pediatric Trials in Antibacterial Drug Development: Findings from the Clinical Trials Transformation Project
Location: Exhibit Hall F
Date & Time: Saturday, April 30, 2016, from 1:30 – 2:45 PM EST
Speaker: Brian Smith, Duke University School of Medicine

CTTI Presents on QbD at Data Quality & Technology In Clinical Trials Conference

Posted on April 18, 2016March 10, 2025 by Lorri Bingham

On Tuesday, April 19, 2016, team leaders from CTTI’s Quality by Design (QbD) project, Ann Meeker-O’Connell and Mark Behm, will present at eyeforpharma’s Data Quality & Technology In Clinical Trials Conference.

This presentation, Examine the value proposition’s implication on trial design, will feature CTTI’s official Quality by Design Recommendations. These recommendations explore specific ways that quality can be built into the scientific and operational design and conduct of clinical trials.

We look forward to connecting with colleagues in the clinical trials enterprise at this event.

NIH and FDA Release Clinical Trial Protocol Template

Posted on April 15, 2016August 12, 2021 by Lorri Bingham

On March 17, 2016 the National Institutes of Health (NIH) together with the Food and Drug Administration (FDA) released for public comment a draft clinical trial protocol template for phase 2 and 3 Investigational New Drug application (IND) / Investigational Device Exemption (IDE) studies. Comments are being accepted until April 17, 2016. The goal of this effort is to allow investigators to more easily prepare protocols that are consistently organized with all the necessary information for review. The agencies welcome and encourage feedback from those involved in the clinical trial enterprise, including investigators, sponsors, members of institutional review boards, and other stakeholders, to help create a robust template for use with future protocols.

Efforts such as this template help to ensure consistency while streamlining protocol development and meeting regulatory requirements. CTTI is a proponent of an efficient, quality-driven, streamlined approach to the design, development, and conduct of clinical trials. Providing materials and resources to facilitate trial design and development is aligned with the CTTI Quality by Design (QbD) approach, and such tools can be easily integrated into clinical trial development plans. CTTI supports and applauds the NIH and FDA for their initiative and encourages similar work.

The draft template released by the NIH and FDA is available here. CTTI recommendations on how QbD principles can be applied to improve the quality and efficiency of clinical trials can be found here.

CTTI Executive Director to Speak at Harvard Webcast, The Forum

Posted on April 14, 2016July 9, 2021 by Lorri Bingham

Tomorrow, CTTI’s Executive Director Pamela Tenaerts will be speaking on an expert panel for The Forum at Harvard T.H. Chan School of Public Health, a live webcasting series that aims to provide decision-makers with a global platform to discuss policy choices and scientific controversies.

This Forum will explore the challenges and complexities of drug trials, and how they impact disease treatment and prevention – particularly for conditions that currently have little or no therapeutic options. As a case study, the panel will discuss Alzheimer’s and several drugs in development for that disease, but also address broader concerns related to the pharmaceutical testing pipeline for unmet medical needs as a whole.

Webinar: DRUG TRIALS: Challenges for Alzheimer’s and Other Urgent Needs
Date: Friday, April 15, 2016
Time: Noon-1 PM ET

Below, you can find information about joining the conversation in real time:

Live tweet with @ForumHSPH #drugtrials
Questions for panelists can be sent to theforum@hsph.harvard.edu

If you are unable to attend the webcast tomorrow, a recording of this event will be available next week and we will provide updates on the CTTI blog.