CTTI Project: ABDD Peds Trials
The number of clinical trials enrolling children is far lower than for adults, and the scope of research is also narrower, according to an analysis of public-access data conducted by researchers at Duke University.
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The ClinicalTrials.gov Reporting Challenges Project is conducting a survey following in-depth interviews that were conducted in late 2021. We invite individuals who provide oversight, register, and/or report trial results information on ClinicalTrials.gov to complete the survey. You may also forward this survey to others who you know register and/or report clinical trial information on ClinicalTrials.gov.
Additional information for potential survey participants is provided below.
What are you being invited to do?
CTTI is conducting a survey to learn more about organizations’ experiences with registering and reporting clinical trial information on ClinicalTrials.gov.
We invite individuals at organizations such as academic institutions, medical product companies, government agencies, and non-government organizations who provide oversight, register, and/or report trial results information on ClinicalTrials.gov to complete the survey.
The survey focuses on policies and approaches your organization implements to comply with ClinicalTrials.gov regulatory requirements, as well as the advantages and disadvantages of your approaches, challenges faced, and suggested strategies for addressing challenges.
How will CTTI use the information?
CTTI will outline useful practices for improving the reporting of timely, accurate, and complete registration and results information on ClinicalTrials.gov.
Your name and organization will not be included when CTTI reports the survey findings. CTTI will send the FDA an aggregated summary of survey findings to inform their approach to supporting more complete reporting of clinical trial information.
Interested in participating?
If you provide oversight, register, and/or report clinical trial information on ClinicalTrials.gov, please click on this link to take the survey.
You may also forward this survey to others who you know register and/or report clinical trial information on ClinicalTrials.gov.
Have questions?
For questions about this survey, please email CTTI Project Manager Kelly Franzetti.
A recording of CTTI’s public webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” is now available.
During the webinar, presenters Lindsay Kehoe (CTTI) and Alicia Staley (Medidata) discussed CTTI’s current work to obtain reliability and acceptance of meaningful, digitally derived novel endpoints – a project that builds on CTTI’s existing novel endpoint development recommendations and resources from 2017. They also provided:
This webinar built on recent webinars by DiMe, which focused on the best resources currently available for using digitally derived endpoints, and TransCelerate, which demonstrated key considerations and challenges for developing novel digital endpoints through a hypothetical case study.
“As the novel endpoints space continues to evolve, CTTI, DiMe, and TransCelerate are committed to working together to help stakeholders across the clinical trials enterprise evolve with it,” said Kehoe. “By encouraging greater collaboration and innovation among technology companies, academic investigators, patients, regulators, and trial sponsors and sites, we can accelerate progress to the benefit of everyone involved.”
For more on CTTI’s work around Novel Endpoints, please visit CTTI’s website.
On Oct. 5 at noon ET, the Clinical Trials Transformation Initiative (CTTI) will host a public webinar on “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” – the third in a series of webinars on using novel digitally derived endpoints in clinical trials for medical product development from CTTI, Digital Medicine Society (DiMe), and TransCelerate.
Presenters Lindsay Kehoe, CTTI, and Alicia Staley, Medidata, will discuss CTTI’s current work to obtain reliability and acceptance of meaningful, digitally derived novel endpoints – a project that builds on its existing novel endpoint development recommendations and resources from 2017.
Attendees will hear:
This webinar builds on recent webinars by DiMe, which focused on the best resources currently available for using digitally derived endpoints, and TransCelerate, which demonstrate key considerations and challenges for developing novel digital endpoints through a hypothetical case study.
“As the novel endpoints space continues to evolve, CTTI, DiMe and TransCelerate are committed to working together to help stakeholders across the clinical trials enterprise evolve with it,” said Kehoe. “By encouraging greater collaboration and innovation among technology companies, academic investigators, patients, regulators and trial sponsors and sites, we can accelerate progress to the benefit of everyone involved.”
Register to attend “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” today.
Topics Included: Data Collecting and Reporting, Regulatory Submissions + Approvals
SHARE TO:
Timely, accurate, and complete registration and reporting of summary results for applicable clinical trials on ClinicalTrials.gov are crucial for providing patients, providers, researchers, and the public with access to information about clinical trials and their outcomes. Despite regulatory requirements and the importance of transparency in increasing knowledge of potential new treatments, multiple publications have reported gaps in clinical trial registration and results submission to the data bank.
To address this issue, CTTI collaborated with the U.S. Food and Drug Administration (FDA) on a project to understand barriers to timely, accurate, and complete registration and reporting of summary results for applicable clinical trials on ClinicalTrials.gov. The project involved in-depth stakeholder interviews and a survey to identify key challenges and explore potential solutions.
CTTI assessed the relevant themes and condensed the findings into a report containing strategies and recommendations for improving registration and reporting of summary results for applicable clinical trials. These strategies include proactive approaches to comply with regulatory requirements, keeping principal investigators and study teams informed, and providing education and guidance on meeting requirements. You can read the full report for a complete list of strategies.
Additionally, CTTI is developing a list of resources to assist with registering applicable clinical trials and reporting results on ClinicalTrials.gov.
Timely and complete registration and results reporting of clinical trial information is an important part of keeping patients, providers, researchers, and the public informed about clinical trials. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that the responsible party for an applicable clinical trial register and submit results information for the trial to the ClinicalTrials.gov databank to promote transparency and accountability, in an effort to limit duplicity and encourage others to build on results. Despite the importance of this goal, public reporting has suggested that not all clinical trials are registered in a timely manner or have incomplete results.
To address this problem, CTTI is launching a new project to identify the challenges that lead to late registration and incomplete or missing results information for applicable clinical trials. The project will use in-depth stakeholder interviews and surveys to identify and explore the key challenges to timely submission of clinical trial information and identify potential solutions. The project will explore factors other than those related to the ClinicalTrials.gov platform and is intended to be complementary to the National Library of Medicine’s ClinicalTrials.gov Modernization initiative.
CTTI will use this data to develop informed best practices for responsible parties and other stakeholders. The findings from this project may also provide potential ways to support responsible parties in meeting the registration and results reporting requirements.
Topics Included: Regulatory Submissions + Approvals
Program: Antibacterial Drug Development
Related Projects: Antibacterial Drug Development HABP/VABP Studies, Antibacterial Drug Development Streamlining HABP/VABP Trials, Antibacterial Drug Development Unmet Need
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Children often respond differently to medications approved for adults, and therefore pediatric trials are required and critically needed for new antibiotics in order to inform dosing, efficacy, and safety.
Use CTTI’s recommendations to design pediatric antibacterial trials that ensure adequate enrollment, decrease the burden on sites and families, understand special considerations for neonates, develop appropriate informed consent procedures, and increase engagement with healthcare providers.
