Author: Lorri Bingham

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.

Registry-Based Clinical Trials: Expert Meeting Materials Now Available

Posted on by Lorri Bingham

On March 30, 2016, CTTI’s Registry Trials Project held a multi-stakeholder expert meeting to accomplish the following:

  • Identify essential elements of registries needed to successfully embed and conduct registry-based clinical trials
  • Present findings from the project’s literature review and expert interviews
  • Receive feedback on potential benefits of and existing barriers to the use of registries in clinical trials
  • Reach consensus on best practices to increase adoption of clinical trials within registries

The meeting included more than 40 participants from academia, government agencies, industry, and patient representatives. A key takeaway was that a role exists for registries in creating a sustainable infrastructure to conduct regulatory trials, including early development, pre-market, and post-approval investigations. Suggestions were generated around considerations including data quality, regulatory issues, governance, and registry design. Input from the meeting, along with evidence gathered through the CTTI project, will be used to develop recommendations and tools to increase the value, acceptance, and success of registry-based clinical trials.

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

CTTI’s New Website Features Content to Improve Clinical Trials

Posted on by Lorri Bingham

In furtherance of our quest to drive adoption of practices that will increase the quality and efficiency of clinical trials, CTTI has launched a new website that provides easy access to recommendations and tools that can lead to better clinical trials.

What’s new?

  • CONTENT NOW ORGANIZED BY TOPIC: The new website packages CTTI’s robust portfolio of work into intuitive, easy-to-navigate topics, such as central IRBs and recruitment.. Within each topic, the new layout gives prominence to critical content, including latest news and most used resources.
  • OPTIMIZED, RESPONSIVE LAYOUT: The updated design features a responsive layout, which will optimize the visitor’s experience across devices and browsers.
  • NEW URLs: New URLs will exist for the project and program pages, but don’t worry! We are setting up re-directs to make this transition as seamless as possible for you. This means that the old URLs will still work, but cleaner, more direct URLs will exist for content related to projects and programs.

If you are having issues locating content, you can:

  • Try the search bar, located in the top right corner of our site
  • Email our communications specialist, Noel Benedetti (noel.benedetti@duke.edu)

We welcome your feedback on the new site. If you have any suggestions for improvement, please send your thoughts to Noel. Thank you for your patience and input as we continue to improve your access to resources that help drive change in the clinical trials enterprise.

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)

 

FDA and CTTI to Collaborate on New Patient Engagement Initiative

Posted on by Lorri Bingham

The FDA and the Clinical Trials Transformation Initiative (CTTI) will be collaborating to establish a new external work group related to patient engagement at the FDA. The FDA has long involved patients and considered patient perspectives in its work. This new initiative is part of the FDA’s continued commitment to fostering greater patient participation and input in regulatory medical product matters. Stakeholders suggested an external work group as a way for FDA to enhance patient engagement (View Report).

The FDA will leverage CTTI’s strengths in multi-stakeholder engagement to coordinate the new work group. CTTI, a public-private partnership, has a strong community of patient advocates and caregivers within its membership. The new work group will create a forum to exchange information, ideas, and experiences on matters of interest to patients and patient advocates related to patient engagement at the FDA. The work group will be similar to the European Medicines Agency’s Patients’ and Consumers’ Working Party, which marks its 10th anniversary in June 2016.

Additional details will be released as the work group develops.

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.

Learn About CTTI at FDA’s Regulatory Education for Industry (REdI) Conference

Posted on by Lorri Bingham

At the Regulatory Education for Industry (REdI) Conference, regulatory educators from the U.S. Food and Drug Administration (FDA) provide information to small drug and device manufacturers. On May 18, 2016, Kristen Miller, PharmD of OMP/CDER, will provide an overview of CTTI. CTTI was co-founded as a public-private partnership between Duke University and the FDA and develops projects culminating in recommendations and tools for transformational changes to clinical trials.

The presentation will review why CTTI was created, its mission and vision, CTTI’s array of projects, recommendations and implementation tools available, and how implementing the proposed changes could help to improve the clinical trial enterprise. CTTI was established as a public-private partnership between Duke and FDA and now comprises over 70 member organizations representing all stakeholders from across the clinical trials enterprise.

If you are attending the conference, we invite you to attend the session:

REdI Spring 2016 Conference

Conference Location: Bloomington, Minnesota

Topic: Increasing the Quality and Efficiency of Clinical Trials: The Clinical Transformation Trials Initiative (CTTI)
Date & Time: Wednesday, May 18, 2016, from 1:00-2:00 PM
Speaker: Kristen Miller, FDA/CDER

 

CTTI’s New Recommendations for Data Monitoring Committees

Posted on by Lorri Bingham

Today, CTTI unveiled new recommendations on best practices for the use of Data Monitoring Committees (DMCs), an important approach 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.

CTTI recommendations are intended to enhance the functioning of a DMC, beginning with the 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. The recommendations were presented during a session at the Society of Clinical Trials (SCT) annual meeting. Dr. David DeMets, a thought leader on DMCs, chaired a session that also included project team members Karim Calis of FDA, Raymond Bain of Merck Research Laboratories, and Annemarie Forrest of CTTI.

As noted by Dr. Calis,
“DMCs play a unique and critical role in trial oversight. The clinical trial enterprise–including investigators, sponsors, trial participants, and other stakeholders–benefits greatly from having strong, independent DMCs that have adequate resources and sufficient flexibility to carry out their important mission.”

The full recommendations are available on the CTTI website and will also be presented in a CTTI-hosted free, public webinar on June 16, 2016 from 12:00 – 1:00 PM EST (New York, GMT-04:00). See below for additional details on this upcoming webinar:

Speakers:

  • Dave DeMets, PhD, Professor and Chair of the Department of Biostatistics and Medical Informatics, University of Wisconsin – Madison
  • Jane Perlmutter, PhD, Patient Advocate
  • Karim Calis, PharmD, MPH, FASHP, FCCP, Office of Medical Policy, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

Meeting Link:  Click here to join WebEx meeting on June 16
Meeting number: 732 840 380
Meeting password: DMCctti

Or join by phone only:
1-855-244-8681 Call-in toll-free number (US/Canada)
1-650-479-3207 Call-in toll number (US/Canada)
Access code: 732 840 380

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.