CTTI News

New Insights on Data Monitoring Committees Published in Clinical Trials

Posted on by Lorri Bingham

New PublicationCTTI has published a new article in Clinical Trials, Understanding the Functions and Operations of Data Monitoring Committees: Survey and Focus Group Findings.

This article shares insights gathered from research with clinical trial sponsors, data monitoring committee (DMC) members, regulators, and other stakeholders. The results were used in the development of CTTI’s official recommendations to improve the functioning of DMCs and quality of trial oversight.

Read this publication for key findings in the areas of:

  • The role of DMCs and when they are needed
  • Typical DMC composition and methods for identification of members
  • Practices for DMC charters, member contracts, and meetings
  • Methods for enhancing DMC communications
  • Views on DMC member qualifications and ways to develop training

To learn more about CTTI’s DMCs Project, CLICK HERE.

CTTI Publishes Findings on Patient & Physician Perceptions of Streamlined Development for Antibacterial Drugs

Posted on by Lorri Bingham

Over 2 million people in the United States are estimated to become infected with drug-resistant bacteria each year, so new antibacterial therapies are desperately needed. Streamlined drug development approaches have the potential to accelerate the availability of new antibacterial drugs for patients with serious unmet need who have limited or no treatment options. CTTI has published findings on patient and physician attitudes regarding streamlined development approaches for antibacterial drugs in BMJ Open.

Through a series of interviews and focus group discussions, CTTI found that patients and physicians agreed on the usefulness of streamlined approaches in situations of unmet need, but both groups also emphasized the need for careful oversight, transparency in risk communication, and continuous monitoring and reporting of safety and efficacy post-approval.

These findings, which resulted from CTTI’s Unmet Need in Antibiotic Development Project, can help inform the future use of streamlined drug development approaches and communication with stakeholders. For example, patients described information they would like to know when treatment with a drug developed using a streamlined approach is being considered. They also expressed a preference to have early conversations with their providers around the potential use of these treatments before they become seriously ill, when their decision-making may be impaired.

CTTI gathered input on these findings and their impact in a multi-stakeholder expert meeting; a meeting summary is available for additional context. CTTI would like to thank the interview and focus group participants, expert meeting attendees, and project team members who contributed to this work.

Parent & Provider Input on Opportunities to Improve Antibacterial Clinical Trials: Findings Presented at Cystic Fibrosis

Posted on by Lorri Bingham

Breck Gamel presents CTTI posterOn October 27, CTTI presented findings from its Pediatric Trials in Antibacterial Drug Development Project at the North American Cystic Fibrosis Conference. Conducting antibacterial trials in pediatric populations has unique challenges, yet safe and effective therapies are desperately needed for this vulnerable group. We conducted surveys and interviews with pediatric providers, investigators, and parents to determine barriers to conducting these trials and obtain suggestions for strategies to overcome them.

View the poster to learn more about our findings:

  • Perceived barriers to conducting pediatric antibacterial drug trials
  • The need for better engagement with parents
  • Approaches for making studies child- and parent-friendly
  • Strategies for improving communication and enrollment

These findings, along with multi-stakeholder input, are being used to generate recommendations to improve the quality and efficiency of pediatric antibacterial drug trials.

Webinar November 17: Transforming Pragmatic Clinical Trials with Sentinel IMPACT-AFib

Posted on by Lorri Bingham

CTTI Webinar InvitationOn November 17, 2016, CTTI will host a webinar to provide an update on work being done as part of the Uses of Electronic Healthcare Data project. Through this project, CTTI is helping the FDA evaluate the use of its Sentinel System as a national resource for generating evidence that can guide medical decision-making. The Sentinel System was designed as a distributed database of claims data for conducting safety surveillance; the data remain in participating partners’ secure environments for analysis.

Using the Sentinel System for clinical trials has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials. This free webinar will discuss the Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). This proof-of-concept trial will be the first conducted using the Sentinel infrastructure and will serve as a pilot for future intervention studies that address critical public health needs.

IMPACT-AFib will randomize 40,000 patients and providers to test whether a multi-level educational intervention can increase the initiation of oral anticoagulation use among patients with atrial fibrillation meeting guidelines for stroke prevention who have not received such therapy in the preceding year. The trial will also assess outcomes associated with the treatment, including stroke.

Topic: Sentinel IMPACT-AFib: Transforming Pragmatic Clinical Trials Using a Nationwide Distributed Claims Database

Date & Time: Thursday, November 17, 2016, at 12:00 p.m. EST (New York, GMT-05:00)

Presenters:

  • Chris Granger, MD, FACC, FAHA, Professor of Medicine, Division of Cardiology, Duke University Medical Center
  • Sean Pokorney, MD, MBA, Cardiology Fellow, Duke University

When it’s time, click here to join the meeting.

Add to your calendar!

This webinar is OPEN TO THE PUBLIC. Please share with your colleagues!

 

 

Improving Pediatric Trials in Antibacterial Drug Development: Expert Meeting Materials Now Available

Posted on by Lorri Bingham

View Expert Meeting MaterialsOn April 5, 2016, CTTI’s Pediatric Antibiotic Trials Project hosted a multi-stakeholder expert meeting to develop consensus on the mechanisms for improving the conduct and execution of pediatric trials of antibacterial drugs. Findings from the project’s surveys and interviews were presented, and stakeholders from across the clinical trial enterprise provided input on draft considerations for improving pediatric antibacterial drug trials.

Areas of focus at the expert meeting included challenges in designing and conducting pediatric trials (including neonatal studies), pediatric labeling, and informed consent. Potential strategies discussed to address these challenges included developing pan-global networks to conduct pediatric trials using master protocols, achieving alignment between global regulatory agencies, improving awareness of opportunities for industry to communicate with the FDA when designing Pediatric Study Plans, and improving communication in the consent process.

We now invite you to view the materials from this meeting. The multi-stakeholder feedback from the meeting, along with evidence gathered through the CTTI project, is being used to inform the development of recommendations to help achieve higher quality, more efficient pediatric trials for antibacterial drugs. CTTI’s official recommendations are expected to be released in 2017.

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

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

CTTI Welcomes Its Newest Members, Alnylam and ASCO

Posted on by Lorri Bingham

CTTI 2016 Membership

CTTI is pleased to welcome its newest members, Alnylam Pharmaceuticals and the American Society of Clinical Oncology (ASCO).

Alnylam Pharmaceuticals is a pharmaceutical company focusing on the development of new therapeutics that use the RNA interference process to silence disease-causing genes. Their representative joining CTTI’s Steering Committee is Pushkal Garg, Senior Vice President, Clinical Development.

ASCO is the leading professional organization for physicians and oncology professionals caring for people with cancer. Their representative joining CTTI’s Steering Committee is Patricia Hurley, Associate Director, Research and Analysis, Policy and Advocacy Department.

Alnylam and ASCO join over 80 other diverse member organizations that are collaborating with CTTI to develop solutions with real-world impact. CTTI actively engages all stakeholders equally to improve the quality and efficiency of the clinical trials enterprise. Learn more about our diverse membership.

 

*These numbers reflect organizations on CTTI’s Steering Committee. In addition, our membership includes 3 individual patient/caregiver representatives.

CTTI Insights for Research Sites Featured at Upcoming SCRS Summit

Posted on by Lorri Bingham

SCRS Global Site Solutions SummitCTTI’s work will be featured in two presentations at the upcoming Society for Clinical Research Sites (SCRS) Global Site Solutions Summit on October 13-16, a conference aimed at fostering collaboration between industry and sites in clinical research.

CTTI Executive Director Pamela Tenaerts will be sharing insights on initiatives to assist sites as key stakeholders in studies and to improve overall collaboration in clinical research. Tenaerts will reinforce CTTI’s commitment to help sites be successful.

SCRS President Christine Pierre will present CTTI’s research on investigator turnover and its impact on-site resources and overall trial performance. Investigator turnover is a major inhibitor of site efficiency in trials, and Pierre will share ideas for better supporting sites in order to increase PI retention.

CTTI is proud to participate in this conference aimed at building strong partnerships between stakeholders.

 

SCRS 2016 Global Site Solutions Summit
Conference Location: Boca Raton, Florida

Presentation Topic: Investigator Turnover
Speaker: Christine Pierre
Date & Time: October 14, 2016, at 4:10 p.m. ET

Presentation Topic: Sites Matter: Industry Collaboration
Speaker: Pamela Tenaerts
Date & Time: October 14, 2016, at 5:30 p.m. ET

 

 

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.

Recent News Feed

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.