Patient Engagement

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.

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.

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.

CTTI Reveals Findings from Pediatric Antibiotic Trials Project at PAS 2016

Posted on by Lorri Bingham

Conducting antibacterial trials in pediatric populations has unique challenges, which have contributed to the overall complexity of antibacterial drug development. CTTI’s Pediatric Antibiotic Trials Project aims to identify barriers related to scientific and operational issues in the design and conduct of clinical trials of antibacterial drugs for children, as well as develop recommendations to address these challenges.

After conducting surveys with investigators of pediatric antibiotic clinical trials and community providers, conducting qualitative interviews with parents and industry representatives, and reviewing information in the ClinicalTrials.gov database, we now have a body of evidence to inform this discussion. Findings indicate a multiplicity of real and perceived modifiable barriers to participating in or conducting pediatric antibacterial clinical trials, the need for deeper engagement with parents, and the necessity of effective recommendations to improve the design and conduct of these trials. These findings will be presented at the Pediatric Academic Societies (PAS) 2016 Meeting in Baltimore, MD on April 30 – May 3, 2016.

Poster Topic: Pediatric Trials in Antibacterial Drug Development: Findings from the Clinical Trials Transformation Project
Location: Exhibit Hall F
Date & Time: Saturday, April 30, 2016, from 1:30 – 2:45 PM EST
Speaker: Brian Smith, Duke University School of Medicine

 

CTTI Provides Necessary Tools to Implement FDA Vision of Patient Engagement

Posted on by Lorri Bingham

As documented in a recent JAMA viewpoint article, the US FDA is making moves to integrate patient perspectives throughout the continuum of medical product development. While the FDA and other key stakeholders have declared a commitment to create a more effective model for engagement between research sponsors, investigators, and patient groups, no evidence-based guidelines for best practices have existed, until now.

On October 7, CTTI released recommendations that identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools. These recommendations are the result of CTTI’s Patient Groups & Clinical Trials Project.

How and when should patient groups be engaged in the research and development continuum? How do patient groups and sponsors of research best assess each other’s interests, expertise and assets to increase the chances of successful clinical trials and therapy development? We are proud to offer actionable solutions to these questions around patient engagement and encourage you to share them with colleagues involved in the clinical trials enterprise.

“The FDA is committed to integrating patient perspectives into its regulatory evaluations and decision making and also encourages medical product innovators and clinical researchers to collect information on patient perspectives to inform development programs.” (Source: JAMA)

CTTI’s Recommendations on Patient Engagement to be Featured in Friday’s NIH Collaboratory Grand Rounds

Posted on by Lorri Bingham

New Recs on Patient Engagement

On Friday, December 11, members from the Patient Groups & Clinical Trials Project will present CTTI’s actionable, evidence-based recommendations on effective engagement with patient groups at the NIH Collaboratory Grand Rounds webinar. We encourage anyone interested in promoting the patient voice in clinical research to attend.

Webinar Topic: CTTI’s Recommendations on Best Practices for Effective Engagement with Patient Groups Around Clinical Trials

Speakers:

  • Wendy Selig, Founder and CEO, WSCollaborative
  • Scott Weir, PharmD, PhD, Director, University of Kansas Medical Center

Date: Friday, December 11, 2015, 1:00-2:00 p.m. ET

Meeting Info: CLICK HERE to view webinar login details.

Latest CTTI Publication Documents Variation in Practices & Perceptions around Patient Engagement for Different

Posted on by Lorri Bingham

On October 14, 2015, PLoS ONE published Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey. Written by members of CTTI’s Patient Groups & Clinical Trials Project, the objective of this publication was, “to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed.” After analyzing data from 179 survey respondents, significant differences were detected between “stakeholder groups in perceptions of the value of patient group engagement with academia and industry around clinical trials- finding that may represent a significant barrier to engagement that was not identified by the individual stakeholder groups independently.”

In addition to this publication, this CTTI project also developed Official Recommendations on Effective Engagement with Patient Groups around Clinical Trials.

We are pleased to share these free resources, and encourage you to share them with friends and colleagues active in the clinical trials enterprise.

If you are active on Twitter, you can participate in this ongoing conversation with #PGCT.

WEBINAR NOW AVAILABLE: CTTI Recommendations for Effective Engagement with Patient Groups Around Clinical Trials

Posted on by Lorri Bingham

Last week, team members from CTTI’s Patient Groups & Clinical Trials Project presented the official recommendations on effective engagement with patient groups around clinical trials in a public webinar. Released on October 7, 2015, these recommendations identify evidence-based best practices for engaging with patient groups, as well as provide case examples and tools.

We are pleased to share the recording of this webinar:

PRESENTERS:

  • Sharon Hesterlee (Myotonic Dystrophy Foundation)
  • Patricia Cornet (Bristol-Myers Squibb)
  • Scott Weir (KUMC)

CLICK HERE to view the slides from this presentation.

If you are active on Twitter, you can participate in this ongoing conversation with #PGCT.

CLICK HERE to view recordings of other CTTI webinars.