Lorri Bingham, Author at CTTI

Expert Meeting Materials Now Available: Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical

Posted on December 22, 2016March 10, 2025 by Lorri Bingham

On September 29-30, 2016, CTTI hosted a multi-stakeholder expert meeting to begin to develop recommendations for how to develop mobile technology–derived novel endpoints for use in clinical trials. Mobile technologies such as remote sensors have the potential to facilitate continuous, high-quality data acquisition not typically possible with traditional data collection methods. However, it is currently unclear how data from these devices may be used to generate novel endpoints for use in clinical trials.

Meeting attendees drafted four use cases to clarify the pathway for developing novel endpoints derived from data captured using mobile devices:

Use of accelerometers to measure treatment benefit in heart failure, Parkinson’s disease, and muscular dystrophy trials
Use of continuous glucose monitors to measure treatment benefit in diabetes trials

Highlights from this meeting are now available in the meeting summary. As a next step in the MCT Novel Endpoints Project, the team will use the evidence from these four use cases, along with findings from a systematic review that is underway, to inform general recommendations to help promote widespread adoption of mobile technologies in clinical trials.

Meeting attendees included investigators, patient representatives, engineers, algorithm experts, regulators, nonprofit consortia, and statisticians who had experience with the diseases and/or devices discussed.

JAMA Publishes CTTI’s Recommendations for Data Monitoring Committees

Posted on December 13, 2016March 10, 2025 by Lorri Bingham

An article describing key points from CTTI’s Recommendations for Data Monitoring Committees (DMCs) appears in this week’s edition of JAMA. As independent bodies able to review accumulating data for ongoing clinical trials, DMCs fulfill a unique and vital role in ensuring the scientific integrity and safety of clinical trials.

The article details the following:

The unequivocal need for DMCs to review unmasked data
The importance of DMCs reviewing safety and efficacy data together
Appropriate qualifications for DMC members

With the growing use of DMCs for trial oversight, these evidence-based best practices for DMC establishment and conduct can help ensure proper DMC functioning to fulfill their mission. CTTI is pleased to see these recommendations reach a broad audience and is encouraging widespread implementation.

View CTTI’s complete recommendations for additional consensus-driven best practices for DMCs.

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

Recording Now Available: Transforming Pragmatic Clinical Trials with Sentinel IMPACT-AFib

Posted on December 1, 2016March 10, 2025 by Lorri Bingham

Would you like to learn how FDA’s Sentinel System is being used for the first time to conduct a randomized clinical trial?

A recording is now available of CTTI’s webinar discussing Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). The concept for IMPACT-AFib stemmed from a collaboration between CTTI and Sentinel (formerly Mini-Sentinel) on the Uses of Electronic Healthcare Data Project to evaluate the use of Sentinel for conducting randomized trials. Sentinel has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials.

About 5 million people in the United States have atrial fibrillation, and roughly 1 in 5 strokes are due to this condition, representing a significant health burden. While anticoagulation therapy is effective for stroke prevention in this population, only about half of these patients receive this therapy according to guidelines.

The proof-of-concept IMPACT-AFib trial will use the Sentinel System to assess the ability of an educational intervention to increase anticoagulation use in at-risk patients with atrial fibrillation. The webinar discusses considerations encountered in planning for this pragmatic trial:

Identifying eligible patients and treatments received using a distributed database with linkage to pharmacy claims
Conducting a pilot phase
Engaging data partners, providers, and patients in study development
Making decisions regarding randomization and informed consent

WE INVITE YOU TO VIEW THE RECORDING, ALONG WITH THE PRESENTATION SLIDES, TO LEARN MORE ABOUT THIS EXCITING TRIAL AND THE USE OF SENTINEL TO IMPROVE CLINICAL TRIALS.

To view recordings of other CTTI webinars, CLICK HERE.

New Insights on Data Monitoring Committees Published in Clinical Trials

Posted on November 30, 2016March 10, 2025 by Lorri Bingham

CTTI 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 November 22, 2016March 10, 2025 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 November 9, 2016March 10, 2025 by Lorri Bingham

On 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 November 8, 2016August 12, 2021 by Lorri Bingham

On 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.

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 November 1, 2016March 10, 2025 by Lorri Bingham

On 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 October 31, 2016August 12, 2021 by Lorri Bingham

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

Clinical Trials Transformation Initiative

Author: Lorri Bingham