Author: Lorri Bingham

Now Available: CTTI Symposium Presentations

Posted on by Lorri Bingham

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

  1. Welcome and Introduction to CTTI by Pamela Tenaerts, CTTI
  2. Welcome from the Executive Committee by Jacqueline Corrigan-Curay, FDA, CDER
  3. Keynote Address by Robert Califf, Duke University / Verily
  4. Reflection on Quality by Design by Robert Temple, FDA, CDER
  5. Quality by Design Project Overview and Recommendations by Ann Meeker-O’Connell, Johnson & Johnson
  6. Quality by Design Case Study by Julie Dietrich, Amgen, Inc
  7. PGCT Project Overview and Recommendations by Bray Patrick-Lake, Duke Clinical Research Institute
  8. PGCT Case Study by Ron Bartek, Friedreich’s Ataxia Research Alliance
  9. PGCT Case Study by Jeff Sherman, Horizon Pharma
  10. Single IRB of Record Project Overview and Recommendations by Soo Bang, Celegene
  11. 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

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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.

CTTI Impacts Clinical Trials Policy and Practice

Posted on by Lorri Bingham

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.

 

At CTTI, we don’t just generate ideas—we create change. To help implement improvements, we develop resources and hold workshops to facilitate the adoption of CTTI recommendations. Numerous organizations, institutions, and other entities have taken advantage of these resources and are realizing the benefits of more efficient and higher quality clinical trials. We are also prompting widespread improvements in clinical trials through influence at the policy level. Examples include:

As CTTI’s work continues to grow, so do the many examples of our impact—together, we are shaping the future of tomorrow’s better, safer clinical trials.

Four Key Areas Where CTTI Has Transformed Clinical Trials

Posted on by Lorri Bingham

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.

CTTI Celebrates a Decade of Transforming Clinical Trials

Posted on by Lorri Bingham

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 2007, CTTI has completed more than 25 projects related to critical issues affecting clinical trials, including quality by design, recruitment, data monitoring, electronic healthcare data, informed consent, safety reporting, using use of a single IRB of record, and many more. This work has influenced or been cited by FDA, EMA, NIH, and other policymakers, and our resources are used every day by sponsors, investigators, research professionals, patient groups, and others to improve clinical trials.

 

From the beginning, the involvement of all stakeholders has been integral to CTTI’s work. Individuals from more than 430 organizations have been involved in CTTI project teams or meetings to date. This collaboration has allowed us to see diverse perspectives and create resources that can be used by the many different individuals and groups involved in designing, conducting, and evaluating clinical trials. We remain committed to collaborating with all stakeholders to create consensus-driven, actionable recommendations that are grounded in evidence.

 

We look forward to the next 10 years of working with our stakeholders to enhance the design and conduct of clinical trials, thereby benefitting the entire clinical trials enterprise.

CTTI Selected to Support FDA Efforts to Increase Patient Engagement Through New Collaborative

Posted on by Lorri Bingham

CTTI has been engaged by the U.S. Food and Drug Administration (FDA) to support its Patient Engagement Collaborative (PEC), an effort created in partnership with CTTI to bring together members of the patient community to discuss the best ways for patients to participate in the FDA’s regulatory discussions about medical products.

“Engaging patients as partners in the development of medical products is critical to the success of the clinical research enterprise, and CTTI is pleased to be hosting this new forum for patients and regulators to discuss and exchange ideas,” said Pamela Tenaerts, MD, MBA, CTTI Executive Director. “This is an important initiative that will benefit not only patients and regulators, but all stakeholders in the research enterprise.”

The Patient Engagement Collaborative is being created because of public feedback the FDA requested on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). One suggestion was to create an outside group to give input on patient engagement across the FDA.

“The FDA is committed to expanding its efforts to engage patients in its regulatory decision-making processes and the new PEC will include a diverse group of representatives from outside the FDA who will help enhance the agency’s understanding of how to best engage across patient communities,” said Rachel E. Sherman, MD, MPH, FDA Principal Deputy Commissioner. “CTTI has a well-established network of patients and patient advocates, and we look forward to working with them in this important effort.”

The Patient Engagement Collaborative will bring 16 patients, caregivers, and patient group representatives together with the FDA several times a year to discuss topics such as communication, transparency, and new ways for patients and the FDA to work together. The new group will be hosted by CTTI, which has strong ties to the patient community.

Nominations to join the Patient Engagement Collaborative will be accepted until Jan. 29. Learn more about what is expected of members and how to apply in the Federal Register Notice. You are also welcome to join a call hosted by CTTI and the FDA on Fri., Jan. 12, at 2pm ET if you have questions about applying. Join by calling 800-988-9752 and use participant code 4753141.

Join Us for CTTI’s 10 Year Anniversary Symposium

Posted on by Lorri Bingham

You are invited to join past and present CTTI leaders, and experts from across the clinical trials enterprise, for an exciting public symposium to help CTTI celebrate “One Decade of Impact. One Vision Ahead.” The event will take place on Tues., Feb. 6, from 8:30 a.m. – 4:00 p.m. at the DoubleTree by Hilton Hotel in Bethesda, Md.

 

The symposium will feature a lineup of distinguished guest speakers, case studies, and a vibrant exchange of ideas around the future of clinical trials. Presenters include leaders from all sectors involved in clinical trials, including government, industry, academia, and patient groups.

 

Attendees will learn how CTTI has influenced the clinical trials enterprise during the past decade, hear from a number of stakeholders about the benefits of applying CTTI recommendations, and learn how CTTI’s current work will shape clinical trials in the future. The sessions will focus on implementation and impact in areas such as quality by design, patient engagement, and the use of a single IRB of record.

 

View the full agenda and RSVP online today.

 

Please contact Kimberley Smith if you have questions.

 

Confirmed Speakers

 

Two CTTI Papers Explore Perceptions on Enrolling Children in Clinical Trials

Posted on by Lorri Bingham

Two papers from CTTI’s Peds Trials work on barriers to enrolling children in clinical trials were recently published in Contemporary Clinical Trials Communications. Despite the fact that pediatric trials are required for new drugs, these trials can be especially difficult to design, enroll, and complete. CTTI’s papers explore the challenges from both the provider and parent perspective and suggest ways to overcome them.

Based on feedback from parents, providers, and other stakeholders, CTTI developed actionable recommendations to address the challenges of enrolling children in clinical trials. These recommendations offer practical, evidence-based strategies that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric trials.