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CTTI Presents at Society for Clinical Trials Annual Meeting

Posted on by Lorri Bingham

There will be several opportunities to learn how CTTI recommendations can improve quality and efficiency of your clinical trials at the Society for Clinical Trials (SCT) 37th Annual Meeting, taking place May 15-18, 2016. Presentations will include the release of recommendations from the Data Monitoring Committees Project, as well as tips for collaborating with patient groups when designing clinical trials. CTTI will also have two posters for viewing: one on improving the informed consent process and one on how CTTI is improving the quality and efficiency of clinical trials.

If you are attending the conference, we invite you to stop by and learn more:

SCT 37th Annual Meeting

Presentation: Recommendations from the Clinical Trials Transformation Initiative Data Monitoring Committee Project
Date & Time: Monday, May 16, 2016, from 10:45 AM-12:15 PM EST
Speakers: Dave DeMets, Karim Calis, Ray Bain, Annemarie Forrest

Click here to learn more about the DMCs project.

 

Poster: CTTI’s Recommendations for Improving Informed Consent
Date & Time: Monday & Tuesday, May 16 – 17, 2016
Speaker: Annemarie Forrest

Click here to view recommendations and tools from the Informed Consent Project.

 

Poster: The Clinical Trials Transformation Initiative: Improving the Quality and Efficiency of Clinical Trials
Date & Time: Monday & Tuesday, May 16 – 17, 2016
Speakers: Pamela Tenaerts, Martin Landray, Christine Pierre, Ted Lystig, Annemarie Forrest

 

Presentation: Collaborating with Patient Advocacy Groups at the Design Stage of Your Clinical Trial: Why It Is So Important
Date & Time: Tuesday, May 17, 2016
Speaker: Bray Patrick-Lake

Click here to view recommendations and tools from the Patient Groups in Clinical Trials Project.

 

 

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

Posted on 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 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 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 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 – 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 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