Ensuring Quality

Webinar Recording Available: Global Expert Panel on Antibacterial Drug Development

CTTI News | September 15, 2016

Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Regulatory Submissions + Approvals

On August 24, 2016, CTTI hosted a webinar on innovative approaches to transforming antibacterial drug development as recently featured in a Clinical Infectious Diseases (CID) supplement. The presentation highlighted the important role public-private partnerships play in advancing the field of antibacterial drug development and included an inside look at CTTI’s two new sets of recommendations for streamlining HABP/VABP trials. Thought leaders from CTTI, FDA, industry, and academia spoke, reflecting on the significance of this new body of work.

We are now pleased to share the webinar recording, in which you can hear more about:

  • Use of an evidence-based approach to characterize the challenges of studying new antibacterial drugs
  • Actionable solutions to these challenges developed from collaborations between multiple stakeholders
  • Ongoing work to determine the promise and potential implications of an early enrollment strategy for HABP/VABP trials

Learn more about CTTI’s Streamlining HABP/VABP Trials Project and Antibacterial Drug Development Program.

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Unmet Need in Antibiotic Development: Expert Meeting Materials Now Available

Posted on by Lorri Bingham

On March 1, 2016, CTTI hosted a multi-stakeholder expert meeting for its Unmet Need in Antibiotic Development Project. This project is investigating perceptions of antibacterial drugs developed using accelerated pathways. Non-traditional development pathways can expedite the availability of much-needed new antibacterial therapies, but there is a tradeoff in risk and uncertainty.

At the expert meeting, results were presented from focus groups and interviews conducted to elicit opinions from patients, healthy persons, caregivers, and physicians on the use of antibacterial drugs developed using streamlined approaches. Meeting attendees, which included representatives from academia and pharmaceutical companies, patient advocates, regulators, and other stakeholders, discussed ways to improve labeling, risk communication, and public understanding in the context of streamlined antibacterial drug development approaches. This input informed interpretation of the findings and project next steps. We are now pleased to share the meeting materials, which may inform others working to address the serious public health issue of antibacterial resistance.

CLICK HERE to access the meeting summary, slides, agenda, and other materials.

This project is part of CTTI’s Antibacterial Drug Development Program.

Recording Now Available: Webinar on Improving Clinical Trial Recruitment

Posted on by Lorri Bingham

On May 19, 2016, CTTI hosted a webinar on moving recruitment planning upstream to reduce barriers to clinical trial participation. This webinar was the official unveiling of CTTI’s new recommendations and tools resulting from the Recruitment Project. We are now pleased to share the recording from this webinar, in which you 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 slides and responses from the webinar’s Q&A session are also available for download.

We encourage you to share these resources with your colleagues in the clinical trials enterprise.

To view recordings of other CTTI webinars, CLICK HERE.

Recording Now Available: Webinar on Best Practices for DMCs From CTTI’s Latest Recommendations

Posted on by Lorri Bingham

On June 16, 2016, CTTI hosted a webinar on its new recommendations on best practices for the use of Data Monitoring Committees (DMCs). This webinar provided an opportunity to learn about ways to enhance the functioning of DMCs through member training, clear roles and responsibilities, charter development, communication practices, and more. The recommendations resulted from CTTI’s DMCs Project.

We encourage you to share this recording with your colleagues in the clinical trials enterprise.

 

Upcoming Webinar: Quality by Design for Clinical Trials

Posted on by Lorri Bingham

On August 10, CTTI will present Clinical Trial Quality by Design: Factors Critical to Quality, a joint webinar with the Medical Device Innovation Consortium (MDIC). The presentation will feature strategies for designing quality, efficient clinical trials from CTTI’s Quality by Design (QbD) Project and MDIC’s Clinical Trial Design Working Group. MDIC was able to build upon CTTI’s QbD recommendations and address special considerations for the design of medical device clinical trials. This work demonstrates a strong synergy between two multi-stakeholder public-private partnerships dedicated to improving clinical trials.

We invite you to join this free, public webinar to learn more about quality design for clinical trials, including medical device trials.

CLICK HERE to register.

Topic: Clinical Trial Quality by Design: Factors Critical to Quality

Date & Time: Wednesday, August 10, 2016 at 1 p.m. ET

Speakers:

  • Susan Alpert, MDIC Clinical Trial Design Working Group Chair
  • Ann Meeker-O’Connell, CTTI QbD Project Team

Upcoming Webinar: Global Expert Panel on Antibacterial Drug Development

Posted on by Lorri Bingham

CTTI invites you to participate in a free, public webinar to learn about collaborative and innovative approaches to address the international public health crisis of antibacterial resistance. A panel of preeminent thought leaders will present these efforts, which appear in a recently published peer-reviewed supplement in the journal Clinical Infectious Diseases (CID).

The webinar will include the presentation of two new sets of CTTI recommendations designed to advance clinical trials for an important and particularly challenging area of antibacterial drug development: hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

This work is part of CTTI’s Antibacterial Drug Development (ABDD) Program, which includes a portfolio of projects tackling specific issues intended to improve clinical trials evaluating potential new antibacterial drugs.

We encourage you to share this invitation with others who may be interested in learning more about CTTI’s ABDD Program and the HABP/VABP Recommendations.

Webinar Title: Antibacterial Drug Development in a Time of Great Need: Global Expert Panel

Date & Time: Wednesday, August 24, 2016, from 12:00 p.m. – 1:00 p.m. EDT (New York, GMT-04:00)

Speakers:

  • Edward Cox, MD, MPH, U.S. Food and Drug Administration
  • Vance G. Fowler Jr, MD, MHS, Duke University
  • Bruno François, MD, University Hospital of Limoges, France
  • Hasan S. Jafri, MD, MedImmune
  • John H. Powers III, MD, George Washington University School of Medicine
  • John H. Rex, MD, AstraZeneca Pharmaceuticals
  • Pamela Tenaerts, MD, MBA, Clinical Trials Transformation Initiative

Webinar Login: CLICK HERE to enter the meeting.

Meeting Number: 730 531 918

Meeting Password: ctti

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)

Clinical Trials Transformation Initiative Releases Recommendations to Enhance the Feasibility of Developing New Antibacterial Drugs

Posted on by Lorri Bingham

Today, CTTI released two new sets of recommendations designed to advance clinical trials for an important and particularly challenging area of antibacterial drug development: hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). This work is part of CTTI’s antibacterial drug development program, which includes a suite of projects tackling specific issues to improve clinical trials and bolster the pipeline for new antibacterial drugs.

CTTI’s new recommendations outline innovative approaches to designing clinical trials for HABP/VABP, including early enrollment strategies and the streamlined collection of safety data. CTTI convened multi-stakeholder teams to analyze the challenges associated with HABP/VABP trials and develop the proposed solutions. The feasibility of these new approaches will be tested in an upcoming pilot study, the findings of which are expected to help drive the adoption of streamlined practices for antibacterial drug development across the clinical trial enterprise.

“The CTTI project teams’ work is the type of science that can benefit the overall field of antibacterial drug development by advancing the science of clinical trials for hospital-acquired and ventilator acquired pneumonia,” said Edward M. Cox, M.D., M.P.H., Director of the Office of Antimicrobial Products from the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research. “We look forward to continued progress of the CTTI effort and the results from additional studies that will evaluate proposed solutions to these challenges.”

CTTI’s latest recommendations appear as part of a peer-reviewed supplement in the journal Clinical Infectious Diseases that features collaborative and innovative approaches by CTTI and others to address this pressing public health concern and speed new treatments to patients.

“This supplement from Clinical Infectious Diseases is really impressive and broad, highlighting many of the problems within antimicrobial resistance, from how to improve the development of new drugs, to engaging with the private sector. I am delighted to see such a prestigious scientific journal engage with this issue in a holistic approach looking at policy as well as scientific actions that need to be taken” said Jim O’Neill, Chair of the AMR Review.

Antibacterial resistance is an international public health crisis, and new treatment options are urgently needed. HABP/VABP occurs in seriously ill patients and is associated with high rates of antibiotic resistance and mortality. Multiple comorbidities, the rapid time course of acute illness, and other factors make conducting clinical trials in this population especially complex. “As someone whose susceptibility to multiple infections and Pneumonias has plagued me for six decades, these recommendations signal a transformational breakthrough,” said Stephen Mikita, patient advocate.

On August 24, CTTI will host a public webinar on this topic: Antibacterial Drug Development in a Time of Great Need: Global Expert Panel.

Best Practices for the Use of DMCs: Join Us for a Webinar Unveiling CTTI’s Latest Recommendations

Posted on by Lorri Bingham

The Clinical Trials Transformation Initiative (CTTI) invites you to participate in a webinar to learn about its new recommendations on best practices for the use of Data Monitoring Committees (DMCs), intended to enhance the functioning of a DMC, beginning with training of members.  Other issues addressed by CTTI include the role and responsibilities of the DMC, composition of members, development of a charter, and communication with the trial sponsor and others.  CTTI’s recommendations can help to ensure the validity and integrity of a clinical trial when there is a need to periodically review accumulating safety and efficacy data and advise on whether to continue, modify, or terminate a trial based on the benefit-risk assessment.

  • Topic:  DMC Project Recommendations
  • Date:   Thursday, June 16, 2016
  • Time:  12:00 p.m. – 1:00 p.m. EST (New York, GMT-05:00)
  • Presenters:
    • Karim Anton Calis, PharmD, MPH, FASHP, FCCP, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
    • Jane Perlmutter, PhD, Patient Advocate
    • Dave DeMets, PhD, Professor, Department of Biostatistics and Medical Informatics, University of Wisconsin – Madison

This webinar is open to the public.  We encourage you to share this invitation with others who may be interested in learning more about CTTI’s DMCs Project Recommendations.

To join:

Meeting Link: Join WebEx meeting
Meeting Number:  732 840 380
Meeting Password: DMCctti
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)

 

Earlier Strategic Planning Key to Clinical Trial Recruitment, According to New CTTI Recommendations

Posted on by Lorri Bingham

CTTI has released new recommendations and tools for enhancing the efficiency of clinical trial recruitment. Patient recruitment is a leading challenge in the efficient completion of clinical trials, which can result in wasted resources and delays in bringing new therapies to market. The foundational principle for this new approach is that recruitment planning should be started earlier in the clinical trial development process and continue throughout the implementation.

DOWNLOAD THE RECOMMENDATIONS

“The Recruitment Project recommendations are the result of an in-depth study evaluating why too often clinical trial recruitment efforts fail,” said Jonca Bull, MD, the FDA’s Assistant Commissioner for Minority Health. Bull served as a team lead for the Recruitment Project. “These recommendations have the potential to catalyze greater efficiencies in diverse patient recruitment–women, minorities, and older adults–by focusing on the earliest stages in protocol development.”

The recommendations and tools were developed with input from a diverse team of stakeholders, including clinical researchers, patient advocates, and representatives from academia, industry, and the FDA. “What we found was that, to truly make a difference, we need a comprehensive solution that covers all areas of clinical research, from making sure the study is asking the right questions–questions that matter to patients and providers–to shaping study design and feasibility, to budget and implementation,” said Kelly McKee, a project team member from Eli Lilly and Company. Among the released tools, a new framework outlines considerations for strategic recruitment planning throughout all stages of a clinical trial.

According to the recommendations, recruitment planning should also be more inclusive of all relevant stakeholders. “Too often important feedback from patients, study coordinators, and health care providers is not obtained when their insights can make or break a trial and prevent avoidable amendments,” said Bray Patrick-Lake, Director of Patient Engagement for the Duke Clinical and Translational Science Award. “CTTI’s evidence-based recommendations and toolkits provide practical guidance for successful clinical trial recruitment planning that will help ensure stakeholders are appropriately engaged and the right questions are asked during study design, feasibility, and recruitment planning activities.”

A thoughtful approach to recruitment planning before study activation is expected to alleviate downstream recruitment challenges and ensure trial viability. The work builds on CTTI’s previous advancements in the areas of engaging patient groups in clinical trials and a quality by design approach to improving clinical trials.

New CTTI Publication Promotes Quality by Design Principles to Enhance Clinical Evidence

Posted on by Lorri Bingham

The growing cost and complexity of clinical trials is threatening the ability to generate new evidence to improve healthcare. CTTI’s latest publication, Enhancing Clinical Evidence by Proactively Building Quality Into Clinical Trials, from the Quality by Design (QbD) Project summarizes recommendations and tools for streamlining clinical. The QbD framework aims to promote critical thinking about trial design and oversight to reduce errors that matter while eliminating non-essential activities. By applying these principles, efforts can be focused on activities that are necessary for the reliability of trial findings and the protection of study participants.

The official QbD recommendations were released in 2015. In the recent publication, the authors describe the process for recommendation development in which stakeholders from across the clinical trial enterprise, including patient advocates, clinical investigators, regulatory reviewers, and trial sponsors, contributed perspectives through workshops and qualitative interviews.

The article was published in the journal Clinical Trials. To read the full publication, click here.