Novel Endpoints

New Publication: CTTI Presents a Systematic Review of Respiratory Tract Infection Trials Available on ClinicalTrials.gov

Posted on by Lorri Bingham

Annals of the American Thoracic Society published Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov on September 11, 2015. CTTI, in collaboration with the FDA, analyzed data from respiratory tract infection (RTI) trials registered between 2007 and 2012 on ClinicalTrials.gov to identify gaps in antibacterial research and inform possible interventions to the public health crisis of increasing antimicrobial resistance. Of the 69,779 trials registered between 2007 and 2012, 1,377 (2%) of these were RTI trials, which were found to be more likely than other infectious-disease or non-infectious-disease trials to be funded by industry. However, stratification of RTI trials by registration year revealed that industry funding is decreasing from approximately 65% of RTIs in 2007-2008 to 46% in 2011-2012. RTI trials more frequently evaluated vaccines compared to infectious-disease trials overall. Lower respiratory tract infection (LRTI) trials were mainly focused on bacterial pathogens (78.5%) and the majority of LRTI trials registered between 2007 and 2012 were treatment-focused; however, a multivariable logistic regression analysis indicated that a treatment-focused RTI trial was associated with decreased odds of publication. Despite the increasing emergence of multidrug-resistant microbes, currently FDA-approved antimicrobials were more commonly tested in RTI trials, and the number of trials investigating novel antimicrobial agents was low. Throughout the study period, the number of LRTI trials overall and prevention-oriented LTRI trials did not increase. This was partly attributed to a decrease in industry sponsorship and funding. These findings should prompt an examination of resource allocation in infectious-diseases trials and LRTI trials in particular.

“Our study is the first to characterize the spectrum of RTI trials. This is a critically important topic, as LRTIs are the most common cause of communicable-disease-related deaths worldwide and in the United States (28% and 45%, respectively) but comprise only 3% of infectious-disease trials.”
– Ruopp, et al.

Figure 2

Analyzed from data on ClinicalTrials.gov, Figure 2 displays the declining financial support from industry for RTI trials.

 

To read the publication, click here.

Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov

Posted on by Hannah Faulkner

Respiratory Tract Infection Clinical Trials, 2007-2012: A Systematic Review of ClinicalTrials.gov

CTTI Presents on Cost Drivers of HABP/VABP Phase Three Clinical Trials at ICAAC/ICC 2015

Posted on by Lorri Bingham

We are pleased to announce that CTTI’s HABP/VABP Trials Project will be presenting a poster at ICAAC/ICC 2015. In September, the Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) and the International Congress of Chemotherapy and Infection (ICC) will host this conference, intended for clinical microbiologists, infectious disease physicians, researchers, and pharmacists.

Session Details:

  • Title: Cost Drivers of Hospital Acquired Bacterial Pneumonia and Ventilator Associated Bacterial Pneumonia (HABP/VABP) Phase Three Clinical Trials
  • Date: September 18, 2015
  • Time: 12:00 – 2:00 PM
  • Presenter: Stella Stergiopoulos

We look forward to connecting with colleagues at this event.

Executive Summary Available for CTTI’s Statistical Issues in Antibiotic Development Think Tank II

Posted on by Lorri Bingham

Advances in clinical trial design over the past decade have offered new and accelerated pathways for drug development. Despite this, the development of novel antibacterial therapies is lagging due to scientific and economic challenges. To address this critical unmet need, CTTI has hosted meetings 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.

On November 19, 2014, CTTI, in collaboration the FDA’s Antibacterial Statistics Working Group, convened the second meeting of statistical and medical experts in the area of antibacterial drug development. The goals of this meeting were to:

  • Provide an update on the current status of statistical methodologies for the design and analysis of antibacterial drugs
  • Discuss ongoing challenges in the development and adoption of innovative methods
  • Generate strategies to propel antibacterial drug development forward

We are pleased to share an Executive Summary of this meeting, in addition to the presentations and agenda. Click here to view all meeting materials.

*This meeting is part of CTTI’s Unmet Need in Antibiotic Development Project.

CTTI Heads to ACRP 2015 to Discuss Central IRBs, Accelerating Antibacterial Drug Development, and More

Posted on by Lorri Bingham

On April 25-28, 2015, the single largest gathering of clinical research professionals in North America, ACRP 2015, will take place in Salt Lake City, Utah. CTTI will be presenting at several events throughout the conference to share our evidence-driven, actionable solutions to the barriers of clinical trial efficiency and quality. We look forward to connecting with our colleagues at the following events:

Presentation: Streamlining protocols for operational efficiency: HABP/VABP trials for unmet need (Poster)
Date: April 25, 2015 from 1:30 – 2:30 PM
Presenter: Sara Calvert (CTTI)

Presentation: Mobile Technology and Clinical Research (Panel)
Date: April 26, 2015 from 8:30 – 10:30 AM
Presenters: Matt Harker (CTTI), Corey Bridges (LifeMap Solutions), Solomon Abiola (University of Rochester)

Presentation: CTTI use of central IRBs for multicenter clinical trials (Concurrent Session)
Date: April 27, 2015 from 8:30 – 9:30 AM
Presenters: Sara Calvert (CTTI), Cynthia Hahn (Feinstein Institute for Medical Research), Soo Bang (Celgene)

Presentation: Strategies to Increase the Efficiency of Good Clinical Practice (GCP) Training (Concurrent Session)
Date: April 27, 2015 from 11:00 AM – 12:00 PM
Presenters: Jonathan Seltzer (ACI Clinical)

For a complete list of upcoming events for CTTI, click https://ctti-clinicaltrials.org/upcoming-events/here.

ABDD HABP/VABP Pilot Study Workshop

FEBRUARY 24, 2015

CTTI Project: HABP/VABP Studies

Meeting Goal

To determine the study design for the CTTI Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia (HABP/VABP) pilot study. The study will test the principles and recommendations identified in the CTTI Program on Antibacterial Drug Development (ABDD).

Meeting Location:

Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Rd, Bethesda, Maryland 20852

Meeting Materials:

Meeting Agenda

List of meeting attendees

Meeting Presentations:

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 Tackles 3 Issues in Clinical Trials with New Projects

Posted on by Lorri Bingham

At CTTI, we are continuously looking for practices that will increase the quality and efficiency of clinical trials. In 2014, three new topics have been added to our portfolio:

  1. Conducting Trials Using Data Registries: Demographic, disease, and outcome data collected in clinical observational registries often overlap with data gathered for clinical trials. Integrating clinical trials within observational data registries may offer opportunities to avoid duplicative data collection and increase efficiency while decreasing clinical trial costs. Objectives for this project include identifying upfront costs and operational adjustments required to utilize a data registry for a clinical trial, as well as recommending best practices for conducting randomized registry trials.
  2. Data Monitoring Committees (DMCs): As the use of DMCs has increased and evolved over the past 40 years, critical issues have emerged. A few of these issues include differences in DMC roles and responsibilities, which contributes to confusion and unclear expectations, as well as a lack of a clear plan for preparing the next generation of DMC members. Objectives for this project include understanding the current landscape of DMC use and conduct, clarifying the purpose of and rationale for using a DMC, and describing effective communication practices between independent DMCs and other trial stakeholders.
  3. Investigator Turnover: While an enormous amount of time and resources are spent initiating new investigators into the clinical trial process, there continues to be a high turnover rate for investigators. As many as 40% of investigators annually choose not to participate in another FDA-regulated trial. This high rate of attrition impacts site and overall trial performance. Objectives for this project include obtaining a more thorough understanding of the factors that influence investigators’ decisions to leave the clinical research practice, as well as defining the impact of investigator turnover on industry and society.

 

CTTI’s #DIA2014 Posters Available Online

Posted on by Lorri Bingham

On June 15-19, the DIA hosted their 50th Annual Meeting (also known as #DIA2014) in San Diego, CA. Several CTTI members and staff attended the conference, and were involved with panels, workshops and poster presentations. We are now pleased to share the posters from this event on our website:

  1. A Collaboration to Facilitate the Development of Antibacterial Agents for Unmet Need: Streamlining Clinical Trial Protocols
    Abstract Summary: This collaboration includes the participation of a multi-disciplinary working group led by CTTI. Several meetings and workshops were held to gain a wider understanding of issues, several solutions using a Quality by Design approach were proposed.
    Presenter: Gary Noel, MD, Senior Director for Janssen Research and Development
  2. Good Clinical Practice (GCP) Training: Identifying Key Elements and Strategies for Increasing Training Efficiency
    Abstract Summary: CTTI convened a multidisciplinary working group involving partners from academia, industry, and government to develop recommendations for streamlining current GCP training efforts.
    Presenter: Jonathan Seltzer, MD, MA, MBA, FACC, President and CEO for Applied Clinical Intelligence, LLC

We would like to thank our colleagues in attendance at #DIA2014 who contributed to this successful conference, and we look forward to seeing you at #DIA2015.

Invent the Future with CTTI at DIA 2014 50th Annual Meeting

Posted on by Lorri Bingham

On June 15-19, the DIA is hosting their 50th Annual Meeting in San Diego, CA. The tagline for this year’s event, Celebrate the Past – Invent the Future, resonates closely with one of CTTI’s own strategic approaches: helping to shape the clinical trials enterprise of the future.

During this week of forward-thinking discussions, we look forward to connecting with many of you. Several CTTI representatives will be presenting, and CTTI will also host a pre-conference tutorial. Specifically, we look forward to sharing our work on quality by design, patient recruitment, antibacterial drug development, and good clinical practice. Below is a schedule of opportunities to hear more about these topics at the conference.

Sunday June 15, 2014

9:00 AM – 5:00 PM – Quality by Design, from Theory to Practice

  • Event Information: Pre-Conference Tutorial TUT44 (*Advanced Registration Required)
  • Presenters: Ann Meeker-O’Connell, Jean Mulinde, John Alexander
Tuesday June 17, 2014

7:15 AM – 4:00 PM – A Collaboration to Facilitate the Development of Antibacterial Agents for Unmet Need: Streamlining Clinical Trial Protocols

  • Event Information: Poster – W30 located in the Sails Pavilion
  • Presenter: Charles Knirsch

8:00 AM – 9:30 AM – Updated Strategies for Effective Recruitment of Patients in Clinical Trials

  • Event Information: Panelist Session #201 located in Room 1B
  • Presenters: Elizabeth Mahon (Chairperson); Margo Michaels, Jonca Bull (Panelists)

1:30 PM – 3:00 PM – Collaborating to Streamline Drug Development: Case Studies of What Works (and What Doesn’t)

  • Event Information: Panelist Session #259 located in Room 2
  • Presenters: Douglas Peddicord (Chairperson); Dalvir Gill, Christine Pierre, Pamela Tenaerts, Ann Meeker-O’Connell (Panelists)
Wednesday June 18, 2014

7:15 AM – 4:00 PM – Good Clinical Practice (GCP) Training: Identifying Key Elements and Strategies for Increasing Training Efficiency

  • Event Information: Poster – T03 located in the Sails Pavilion
  • Presenter: Jonathan Seltzer

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The Possibilities of Conducting Randomized Clinical Trials using Electronic Data in the Mini-Sentinel Environment

Posted on by Lorri Bingham

On May 15th Richard Platt, MD, MS, of Harvard Pilgrim Healthcare, and Patrick Archdeacon, MD, of the FDA, spoke at a CTTI-hosted webinar titled Developing Approaches to Conducting Randomized Trials in the Mini-Sentinel Environment. During this teleconference, Platt and Archdeacon summarized the collaborative work of CTTI and Mini-Sentinel investigators exploring the potential for building on the Sentinel’s health-plan-based teams and data infrastructure to facilitate multi-center clinical trials. A recently released report, Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed Database, fully describes the project and results. Their talk concluded with an explanation of the follow-up phases of this work, which will likely include convening working groups to further advance the concepts put forth in this report and collaborating with other partners.

We are pleased to share the recording of this webinar with the public, and we encourage interested parties to learn more about the Mini-Sentinel.