Formats
JAMA Publishes CTTI’s Recommendations for Data Monitoring Committees
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
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
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
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
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.