Ensuring Quality

Webinar February 16: Improving Pediatric Antibacterial Drug Trials

Posted on by Lorri Bingham

Challenges in conducting antibacterial drug trials for pediatric patients can delay the safe and effective use of treatments for this vulnerable group.  There are now evidence-based, consensus-driven solutions. Are you ready to do better clinical trials for children?

Join us for a special webinar in which CTTI will unveil new recommendations for improving pediatric antibacterial clinical trials:

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Title: CTTI Recommendations from the Antibacterial Drug Development (ABDD) Peds Trials Project
Date: February 16, 2016 12:00 – 1:00 PM EST (GMT-05:00)
Webinar Link: http://bit.ly/2kYGm7j
Speakers:

  • Sumathi Nambiar, U.S. Food and Drug Administration
  • John Bradley, University of California, San Diego
  • Gary Noel, Johnson and Johnson Pharmaceutical Research and Development

The webinar will include practical, evidence-based strategies that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials.

Learn these tips and more for making your trials more successful:

  • Importance of engaging with regulators early and throughout medical product development
  • Methods of streamlining trial design to decrease burden on sites and families
  • Special considerations for conducting trials with neonates
  • Approaches for improving the informed consent process
  • Ways to increase engagement with healthcare providers

Although developed in the context of antibacterial drug development, many of the recommendations can be applied to improve pediatric clinical trials in multiple therapeutic areas.

This webinar is open to the public. Please feel free to share this invitation with your colleagues.

JAMA Publishes CTTI’s Recommendations for Data Monitoring Committees

Posted on by Lorri Bingham

New PublicationsAn 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.

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.

Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis

Posted on by Hannah Faulkner

Patient and physician attitudes regarding risk and benefit in streamlined development programmes for antibacterial drugs: a qualitative analysis

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.

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.