Formats
CTTI Charts New Pathways for Pediatric Antibacterial Drug Development
In an article recently published in the Journal of the Pediatric Infectious Disease Society (JPIDS), CTTI researchers lay out a roadmap for addressing an urgent public health issue: pediatric antibacterial drug development.
Antibacterial drugs are critically important for treating infectious diseases, but growing rates of antimicrobial resistance have made the development of new antibacterial therapies a priority for researchers and physicians. The problem is especially acute in pediatrics, because even when new drugs are developed for adults, it may be up to 10 years before the pediatric clinical trials needed to provide vital information about safety, effectiveness, and dosing in children are completed. The result of these delays is a chronic shortage of information to guide the use of new therapies in pediatric populations.
The JPIDS article, which was distilled from the results of CTTI research and expert stakeholder meetings, identifies five key areas for action aimed at overcoming barriers to conducting timely and efficient trials of new antibacterial drugs in children, including:
- Improving planning for pediatric drug development
- Streamlining processes for protocol development and trial design
- Refining approaches to seeking and obtaining informed consent
- Engaging with healthcare providers
- Emphasizing the rapid incorporation of new information into product labeling
The article reflects recommendations from CTTI’s Pediatric Antibacterial Drug Development Project, which focuses on creating efficient, evidence-based processes for developing, testing, and using antibacterial therapies in children. The “Peds Trials” Project itself is part of the larger CTTI Antibacterial Drug Development Program.
By fostering collaborative approaches that involve all stakeholders, CTTI hopes to accelerate the development of safe and effective pediatric antibacterial drugs—and to equip physicians and other healthcare professionals with the information they need to make the best possible decisions for the health of the children under their care.
Now Available: CTTI Symposium Presentations
For those unable to attend the CTTI 10-year Symposium on Feb. 6, we are pleased to share slides from each of the exciting, informative sessions:
Meeting Presentations
- Welcome and Introduction to CTTI by Pamela Tenaerts, CTTI
- Welcome from the Executive Committee by Jacqueline Corrigan-Curay, FDA, CDER
- Keynote Address by Robert Califf, Duke University / Verily
- Reflection on Quality by Design by Robert Temple, FDA, CDER
- Quality by Design Project Overview and Recommendations by Ann Meeker-O’Connell, Johnson & Johnson
- Quality by Design Case Study by Julie Dietrich, Amgen, Inc
- PGCT Project Overview and Recommendations by Bray Patrick-Lake, Duke Clinical Research Institute
- PGCT Case Study by Ron Bartek, Friedreich’s Ataxia Research Alliance
- PGCT Case Study by Jeff Sherman, Horizon Pharma
- Single IRB of Record Project Overview and Recommendations by Soo Bang, Celegene
- Single IRB of Record Case Study by Hallie Kassan, Feinstein Institute for Medical Research, Northwell Health
Thank you again to all of our esteemed presenters who made the CTTI Symposium a great success! Keep an eye on this blog for a complete recap of the event later this week.
CTTI to Lead Breakout Session and Offer Insights into Using Mobile Tech and Novel Endpoints in Clinical Trials at 2018 SCOPE Meeting
This year’s Summit for Clinical Ops Executives (SCOPE) conference will feature a notable presence from CTTI as part of the annual meeting’s first-ever Sensors, Wearables and Digital Biomarkers in Clinical Trials track. The meeting will take place in Orlando from Feb. 12-15.
CTTI, which recently published a set of recommendations and resources for developing and incorporating novel technology-derived endpoints into clinical research as part of its larger Mobile Clinical Trials (MCT) Program, will lead a breakout session focusing on findings from this project and what they mean for site investigators and patients. Discussion will center on use cases developed from four therapeutic areas—Parkinson’s disease, heart failure, diabetes, and Duchennes muscular dystrophy—and will describe strategies for identifying, developing, and implementing novel endpoints derived from new and emerging technologies, including mobile devices.
The breakout session will be accompanied by a pair of related CTTI presentations taking place over the next two days. The first will provide insights from CTTI’s MCT Stakeholder Perceptions Project exploring patient and investigator views of research involving mobile technologies, and will examine ways to develop a successful patient-centered approach to leveraging mobile technology in clinical trials. The second presentation will offer expert perspectives from CTTI’s MCT Novel Endpoints Project, which addresses uncertainties about how best to incorporate mobile technologies into clinical research and offers pathways for leveraging data derived from such technologies to accelerate research and therapeutic development.
We hope you will join us in Orlando on Feb. 13-15 as we explore evidence-based approaches to integrating novel technologies and endpoints into clinical research.
Interactive Breakout Discussion: Selecting, Developing and Incorporating Novel Endpoints, Generated from Data Captured by Mobile Technologies, for Use in Clinical Trials
Date and time: Tues., Feb. 13, 4:00 p.m. EST
Presenters: Jennifer Goldsack (CTTI), Rob DiCicco (GSK), Amy Calvin (Eli Lilly), and Christian Gossens (Roche)
Presentation: New Findings on Patient and Site Perspectives from the Clinical Trials Transformation Initiative
Date and time: Thurs., Feb. 15, 12:25 p.m. EST
Presenter: Hassan Kadhim (Boehringer Ingelheim Pharmaceuticals)
Presentation: Identifying, Developing and Incorporating Technology-Derived Endpoints into Clinical Trials: A ‘How-To’ Guide
Date and time: Wed., Feb. 14, 11:15 a.m. EST
Presenter: Rob DiCicco (GSK)
CTTI Article in Contemporary Clinical Trials Outlines Framework for Successful Trial Recruitment
A CTTI article outlining a framework for successful clinical trial recruitment planning was recently published in Contemporary Clinical Trials.
While patient recruitment is widely recognized as a key determinant of success for clinical trials, a substantial number of trials still fail to reach their recruitment goals. To address this issue, CTTI convened a project team to examine the challenges and develop actionable, evidence-based recommendations for improving recruitment planning.
These recommendations propose an upstream approach to recruitment planning, focusing on factors that affect recruitment earlier in clinical trial development. The recommendations focus on three essential areas in particular:
- Trial design and protocol development: Identifying all stakeholders, ensuring the relevance of the scientific question, limiting complexity, having realistic eligibility criteria, and optimizing data collection.
- Trial feasibility and site selection: Conducting evidence-based feasibility analysis, having realistic metrics and milestones, developing an adequate budget and resources, ensuring appropriate site selection, and engaging in suitable performance monitoring.
- Communication planning: Identifying where participants seek treatment, developing and testing tailored messages, developing creative material and selecting appropriate delivery channels, having a realistic budget, monitoring and evaluating process and performance, and embedding recruitment intervention studies and sharing results.
CTTI also developed resources to help facilitate adoption of the recommendations, including methods for identifying stakeholders and considerations for patient-reported outcomes. Together, the recommendations and tools are designed to guide efforts in clinical trial recruitment planning and identify areas for continual improvement.
New CTTI Article Investigates Mobile Device Use to Measure Outcomes in Clinical Research
A CTTI article recently published in Digital Biomarkers investigates the use of mobile devices to measure outcomes in clinical research from 2010-2016. The article provides a detailed accounting of where the field is currently, allowing researchers to see what measures exist for using or developing technology-derived endpoints, how they are being used, and how to access relevant literature.
The review found that, while mobile devices are widely used to assess outcomes in observational research, their use in interventional research is limited. Additionally, the absence of standardization across the measures used to assess outcomes of interest, units of measurement, sampling rate, device placement, and the technologies themselves indicates a pressing need for standards to interpret and compare results across studies and across therapeutic areas.
The article offers suggestions for incorporating mobile technology into interventional research—such as consolidating evidence supporting the clinical meaningfulness of specific technology-derived endpoints, and standardizing the use of mobile devices in clinical research to measure these endpoints.
The review also found that:
- The majority of technology-derived novel endpoints are currently being used in cardiac studies. However, in randomized controlled trials, technology-derived novel endpoints are most commonly used in Type I diabetes studies.
- Physical activity measures are the most commonly used technology-derived endpoints in clinical studies. Other commonly used endpoints are related to sleep, mobility, and pill adherence, as well as biomarkers such as cardiac, glucose, gastric reflux, respiratory measures, and intensity of head-related injury.
- There is a scarcity of technology-derived measures being used as actual outcome assessments in studies of neurological diseases such as Parkinson’s and Alzheimer’s, which have a considerable unmet need for measures. Oncology and nephrology are two other key therapeutic areas with unmet need for better assessments, but a dearth of technology-derived measures.