CTTI News

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.

CTTI Launches New Project to Accelerate Use of Real-World Data in Clinical Trials

Posted on by Lorri Bingham

New approaches to clinical research that harness diverse sources of “real-world data” (RWD) could accelerate the pace of clinical trials, reduce costs, and provide new insights into patient experiences. Keeping at the forefront of this movement, CTTI today announced a new Real-World Evidence Project that is designed to foster greater awareness of these data sources and explore effective ways to leverage them for clinical trials.

Unlike conventional clinical trial data gathered using specialized, costly, and complex systems, RWD is captured from existing sources such as electronic health records (EHRs), billing and insurance claims databases, disease registries, patient generated data, and even mobile devices. When combined and analyzed, these data can yield “real-world evidence” (RWE) that may provide a more accurate and complete picture of patient outcomes and experiences.

However, despite this potential, there have been relatively few attempts to incorporate RWE into trials intended to support regulatory decision making for new medical products and labeling indications—in part because stakeholders have not yet agreed on valid and effective approaches.

CTTI’s RWE work is helping to meet these challenges by:

  • Describing how these sources of data can be leveraged to plan and conduct trials;
  • Identifying and addressing barriers to such use
  • Identifying when RWD/RWE usage may be impractical or unwise; and
  • Developing practical approaches to embedding RWE in clinical research.

Ultimately, broad adoption of RWE for regulatory trials may benefit patients and other stakeholders by efficiently creating high-quality, reliable evidence about the safety and effectiveness of medical products.

CTTI Shares New Insights on Early Enrollment, Barriers to Remote Clinical Trials, and Improving Investigator Trainings at PRIM&R Advancing Ethical Research Conference

Posted on by Lorri Bingham

CTTI will present findings during three sessions at the upcoming PRIM&R Advancing Ethical Research (AER) Conference.

On Mon., Nov. 6, CTTI will share data on stakeholder perceptions of early informed consent and enrollment in clinical trials. While early enrollment could improve the ability to conduct trials that evaluate the efficacy and safety of treatments for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), questions remain about implementing it ethically and effectively. CTTI will share findings from its HABP/VABP Studies Project on the acceptability of an early informed consent approach for high-risk patients and essential information that should be shared with key stakeholders.

On Wed., Nov. 8, CTTI will discuss findings from its MCT Legal & Regulatory Project on actual and perceived barriers that may be preventing the widespread use of mobile technology in clinical trials. Presenters will explore potential challenges and opportunities of conducting clinical research remotely, and solicit input from clinical enterprise stakeholders on potential ethics implications. The project is part of CTTI’s Mobile Clinical Trials (MCT) Program.

In a separate session, CTTI will also present findings to date for its Investigator Qualification project and Investigator Community recommendations. The presenter will examine whether current GCP training methods actually provide the knowledge and skills necessary to conduct quality clinical trials. Further, he will detail recently released recommendations that aim to strengthen the clinical trials investigator and study team community through better training and other approaches.

We hope you will join us in San Antonio, Texas, Nov. 5-8 as we share new insights into these noteworthy clinical trials topics.

Presentation: Stakeholder Perceptions on Early Informed Consent for Clinical Trials
Date & Time: Mon., Nov. 6, 3:30 – 4:45 p.m.
Presenters: Amy Corneli (CTTI) and Thomas Holland (Duke University)

Presentation: Clinical Trials Transformation Initiative (CTTI) Mobile Clinical Trials, Legal, and Regulatory Project
Date & Time: Wed., Nov. 8, 11:15 a.m. – 12:30 p.m.
Presenters: David Babaian (Kinetiq), Linda Coleman (Yale University), and Jan Hewett (FDA

Presentation: Beyond Good Clinical Practice (GCP) Training: Expanding the Tool Set for Preparing Investigators
Date & Time: Wed., Nov. 8, 11:15 a.m. – 12:30 p.m.
Presenters: Gerrit Hamre (CTTI)

New Results on Cost Drivers in Phase 3 Drug Trials for HABP/VABP

Posted on by Lorri Bingham

Drug-resistant infections are on the rise, and one type of serious infection that can be caused by drug-resistant bacteria is hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). Despite the desperate need for effective new therapies for HABP/VABP, clinical trials for this condition are lagging due to difficulties in conducting these trials and low expected return on investment. A new study from CTTI and the Tufts Center for the Study of Drug Development, published in Clinical Infectious Diseases, calculates the cost of phase 3 trials for HABP/VABP and identifies areas of opportunity to lower costs and boost investment in these critically important studies.

“To meet the urgent public health need for new antibacterial drugs, clinical trials must be more efficient, cost-effective and feasibly executed. Our study identified several factors driving clinical trial costs that can be targeted to optimize the development of new treatments,” said Ken Getz, an associate professor and researcher at Tufts University involved in the study.

“Leveraging evidence to direct meaningful changes in clinical trials is what CTTI is all about,” said Pamela Tenaerts, CTTI executive director. “We hope this information will help target efforts to streamline HABP/VABP trials, which will ultimately benefit patients.”

Key findings include:

  • The cost of a phase 3 HABP/VABP clinical trial averages $89.6 million, which is over double the average cost of a phase 3 oncology trial
  • Per patient, phase 3 HABP/VABP clinical trials were $2,300 more expensive than oncology clinical trials and $31,900 more expensive than endocrine trials
  • Screening failure rates and the cost of screening failures were the biggest drivers of cost, suggesting sponsors and research sites should consider ways to increase the number of potentially eligible patients

CTTI released recommendations for streamlining HABP/VABP trials and is testing novel approaches to make these trials more feasible, such as using predictive models to find and consent patients earlier in the disease process.

Webinar Recording Now Available: Strengthening the Investigator Site Community

Posted on by Lorri Bingham

Running a clinical trial at a research site is always challenging, and investigators may sometimes feel like the deck is stacked against them.

CTTI’s most recent webinar, Strengthening the Investigator Site Community, featured expert presenters and panelists discussing the challenges faced by site investigators. They also shared real-life examples of how CTTI’s new recommendations can be used by CROs, sponsors, health systems, investigators, and others to create a more supportive environment for site-based research.

 

 

CTTI Recommendations Strengthening the Investigator Site Community from CTTI on Vimeo.

View the webinar recording to learn how:

  • Workload, reporting burdens, time allocation, and financial issues contribute to high rates of investigator turnover;
  • Investigators and study staff can benefit from improvements to research infrastructure and training and educational opportunities;
  • All stakeholders can contribute to optimizing trial conduct and to developing more efficient and transparent approaches to budgeting and contracting; and
  • Investigators can connect with opportunities to remain engaged in clinical research.

Visit this page for presenter information and to download a copy of the slides.