Quality
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 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.
Four Key Areas Where CTTI Has Transformed Clinical Trials
This year, CTTI marks its 10th year of working with a variety of stakeholders to positively change clinical trials, making them more streamlined, efficient, and patient-focused. To commemorate this milestone, we will #CelebrateCTTI throughout the month of January. Join us for the celebration—visit this blog, follow us on Twitter, and register to attend our 10 Year Anniversary Symposium on Tues., Feb. 6.
Since its inception in 2007, CTTI has made transformational shifts in the design and conduct of clinical research. Let’s take a look at the evolution of clinical trials in four key areas, among many, in which CTTI has played a critical role in moving the industry toward more efficient, high-quality, and patient-centric trials:
Trial Quality
Regulators have long acknowledged a need to change how the industry approaches clinical trial quality in order to focus on reducing errors that undermine data integrity and patient safety. Drawing on the expertise of key stakeholders, CTTI issued recommendations on effective and efficient trial monitoring in 2012. The following year, FDA issued final guidance on a risk-based approach to monitoring, reflecting principles from CTTI’s work. CTTI also developed the concept of Quality by Design, taking the focus from a reactive approach using audits to a proactive approach that builds quality into clinical trials at the outset. CTTI released its Quality by Design recommendations and toolkit in 2015, and its work in this area has been cited in FDA guidance and incorporated into GCP guidelines.
Patient Engagement
CTTI has been a pioneer in patient engagement, involving patient representatives in its organizational leadership and throughout its project teams. Spurred by the FDA’s Safety and Innovation Act of 2012, CTTI initiated the Patient Groups & Clinical Trials Project to establish best practices for engaging patients in clinical research. In 2014, CTTI released landmark recommendations that are currently used by multiple stakeholders to facilitate productive relationships with patient groups around clinical trials. In 2017, CTTI and FDA announced a partnership on a new initiative, the Patient Engagement Collaborative, to improve patient engagement across the FDA.
Central IRB
Although U.S. regulators are enthusiastic about the use of a central IRB to promote more efficient multi-site clinical trials, enterprise-wide implementation has lagged. CTTI initiated the Central IRB Project in 2010, creating recommendations and resources to help organizations identify and address barriers to the adoption of a central IRB. The NIH issued a draft policy in 2014 referencing CTTI’s recommendations and a final policy in 2016 requiring all NIH-funded multi-site clinical trials to use a central IRB effective in 2018.
Real-World Evidence
Since its inception, CTTI has recognized that “real-world evidence” from electronic health records, mobile devices, and other sources can provide unique insights into important clinical questions and could improve the efficiency of clinical trials. The FDA Amendments Act of 2007, which mandated FDA to develop a system to link safety data from multiple sources, paved the way for the use of connected datasets in clinical trials. After partnering with the FDA and Harvard Pilgrim Health Care Institute to assess the feasibility of using the Sentinel database for clinical research, CTTI supported the first trial using Sentinel. CTTI also launched a program in 2016 to support the use of mobile technology in clinical trials, issued recommendations in 2017 on how to use registries as reusable platforms for trials, and announced a Real-World Evidence Project in 2017.
Improved Pregnancy Testing Planning for Safer, More Efficient Clinical Trials: Webinar Recording Now Available
Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk. However, there is little formal guidance on how pregnancy testing should be conducted to prevent unintended exposure, nor how risks should be clearly communicated to women.
CTTI’s new recommendations help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials. CTTI also created the Pregnancy Testing Outcomes Predictor for Clinical Trials, a web application that provides a quantitative method for assessing estimated likely outcomes of different pregnancy testing plans.
A webinar recording is now available detailing the new recommendations and web application, including case examples of their use.
View the webinar recording to learn:
- Steps involved in proactive planning for pregnancy testing before the start of a clinical trial
- A new web application to help assess the balance of benefits and burdens of specific pregnancy testing plans
- Ways study coordinators can improve communication so that women receive clear, comprehensive information before joining a clinical trial
- How these new recommendations promote the safe inclusion of women in clinical trials
Visit this page for presenter information and to download a copy of the slides.
Coming soon: How improved pregnancy testing planning can lead to safer, more efficient clinical trials
CTTI shares new pregnancy testing plan recommendations and an online tool in an upcoming free public webinar
Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk. In an upcoming webinar, CTTI will unveil new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, to conduct safer, more efficient clinical trials.
Attend this webinar to learn:
- Steps involved in proactive planning for pregnancy testing before the start of a clinical trial
- A new online application to help assess the balance of benefits and burdens of specific pregnancy testing plans
- Ways study coordinators can improve communication so women receive clear, comprehensive information before joining a clinical trial
- How these new recommendations promote the safe inclusion of women in clinical trials
Webinar: CTTI Presents Recommendations for Clinical Trial Pregnancy Testing Plans
Date & Time: Thursday, August 24, 2017 12:00–1:00 p.m. ET (GMT-04:00)
Presenters:
- Claire Jurkowski, MD, former medical director, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb (Retired)
- Jessica Morse, MD, MPH, assistant professor, University of North Carolina School of Medicine
- Evan Myers, MD, MPH, professor, Duke University Medical Center
Upgraded AACT Database Offers Improved Functionality for Analyzing ClinicalTrials.gov Data
CTTI has launched an upgraded version of its Aggregate Analysis of ClinicalTrials.gov (AACT) database, which provides an analyzable dataset of all study information (including results) contained in ClinicalTrials.gov. These data can be used to characterize the clinical trials landscape and evaluate trends over time. CTTI gathered user feedback to design enhancements to the tool that would improve the timeliness of data, increase functionality, and make it accessible to a broader group of users.
For years, AACT has been used to uncover insights about the state of clinical trials. The datasets have been downloaded over 17,000 times and resulted in more than 20 publications. With these improvements, AACT will continue to be a valuable resource for assessing the clinical trial enterprise. For example, with the new NIH policy and the Final Rule for FDAAA 801 in effect for clinical trial results reporting, there is an opportunity for more organizations to use this timely and easily accessible data to monitor their compliance.
Previously updated twice per year, the database now resides in the cloud and is refreshed nightly with data from ClinicalTrials.gov. Historical AACT datasets also remain available for comparison. Researchers can query the database directly or download it as a static dataset. The new version of AACT is based on open-source technologies and requires no proprietary software.
Learn more about CTTI’s State of Clinical Trials Project.
CTTI Shares Tools for Improving Trials in 2 Presentations at SCOPE Summit
This year’s SCOPE Summit, taking place January 24-26, 2017, in Miami, FL, will feature three presentations on CTTI recommendations for adopting quality by design, patient engagement, and recruitment in clinical trials. SCOPE, the Summit for Clinical Ops Executives, is focused on issues around clinical trial best practices, and attendees include industry leaders from over 500 organizations. CTTI looks forward to the opportunity to engage with decision-makers across the clinical trial enterprise to improve clinical trial planning and management.
Don’t miss our informative sessions with actionable takeaways:
Presentation: Moving Recruitment Planning Upstream to Reduce Barriers to Participation: Recommendations from the CTTI Recruitment Planning Project
Presenter: Beth Mahon, Janssen Research and Development
Date & Time: Tuesday, January 24 from 11:15 – 11:40 AM ET
Description: Learn the importance of proactivity in clinical trials planning in order to reduce participation barriers. This session will describe recommendations from CTTI’s Recruitment Project, which provide a framework for strategic recruitment planning that begins during the trial design and development process.
Presentation: Patient Group Engagement in Clinical Trials: Best Practices for Best Value
Presenter: David Leventhal, Pfizer, Inc. and Ken Getz, Tufts Center for the Study of Drug Development
Date & Time: Wednesday, January 25 from 5:20 – 5:45 PM ET
Description: Learn to apply actionable recommendations for establishing strong, active patient group engagement during all phases of the research and development life cycle. We’ll also share our net present value model that helps to quantify the value, including financial return on investment, of patient engagement. These tools and best practices resulted from CTTI’s Patient Groups & Clinical Trials Project.