Safety

CTTI Article Explores Facilitators and Barriers Perceived by Investigators to Successful Pediatric Antibacterial Drug Trials

Posted on by Lorri Bingham

Growing rates of antibiotic resistance have made the development of new antibacterial therapies an urgent public health need. This is especially true for the pediatric population, where it may take up to 10 years for clinical trials to determine safety and dosing information.

A CTTI article recently published in Contemporary Clinical Trials Communications shares findings from a survey of 73 investigators to determine facilitators and barriers to the successful conduct of much-needed pediatric antibacterial drug trials. The survey was conducted as part of CTTI’s Peds Trials work.

As outlined in the article, almost all investigators identified two factors as very important facilitators: having strong site staff and adequate funding. Other facilitating factors were related to staff expertise. Investigators rated parent concerns and obtaining consent as the most critical barriers. Other barriers included concerns about the number of blood draws and other invasive procedures, as well as having overly narrow eligibility criteria.

The survey findings suggest three areas in which to focus efforts to help facilitate ongoing pediatric antibacterial drug development:

  1. Improving engagement with parents of children who may be eligible to enroll in a pediatric antibacterial drug trial.
  2. Broadening inclusion criteria to allow more participants to enroll.
  3. Ensuring adequate staffing and establishing sustainable financial strategies, such as funding pediatric trial networks.

These results were used to develop CTTI’s actionable recommendations for facilitating and improving antibacterial drug trials in the pediatric population.

CTTI Continues to Address Barriers to Single IRB Adoption: Latest Expert Meeting Summary Now Available

Posted on by Lorri Bingham

Using a single institutional review board (sIRB) for multisite trials can improve the quality and efficiency of multicenter clinical trials—and beginning Jan. 25, 2018, the National Institutes of Health (NIH) is requiring use of an sIRB for NIH-funded multicenter clinical research.

To help drive adoption of sIRB review, CTTI has developed several recommendations, resources, and tools for use by the research community, and recently convened an expert meeting to discuss further actions that CTTI, the U.S. Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), and NIH can take to ease the transition. The expert meeting included representatives from academia, government agencies, IRBs, pharmaceutical, and device companies, contract research organizations, and patient groups, with the goal of identifying remaining gaps in knowledge and potential solutions to implementing a sIRB model.

Meeting participants highlighted the need for clarity around language and procedures, and emphasized that early collaboration among parties can mitigate the challenges. Participants felt that the time is right to learn from each other by sharing successful models of sIRB review among the private sector, academia, and government research organizations. Next steps from CTTI will involve new projects and committees to develop additional supportive tools and strategies for implementing sIRB review.

CTTI Charts New Pathways for Pediatric Antibacterial Drug Development

Posted on by Lorri Bingham

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:

  1. Improving planning for pediatric drug development
  2. Streamlining processes for protocol development and trial design
  3. Refining approaches to seeking and obtaining informed consent
  4. Engaging with healthcare providers
  5. 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.

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.

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 Shares Challenges and Solutions to Enrolling Participants in Pediatric Trials at AAP 2017

Posted on by Lorri Bingham

At the upcoming American Academy of Pediatrics National Conference, CTTI will offer insights into some of the biggest challenges currently affecting pediatric clinical trial enrollment and conduct. Through a podium presentation and poster sessions, CTTI will share survey-based findings that shed new light on obstacles affecting pediatric trials and discuss possible solutions that can help streamline these studies and reduce burdens on patients, families, and providers.

 

Although clinical trials are essential for ensuring access to safe and effective therapies for children, many studies struggle to enroll pediatric participants and families and providers often lack information to help them make the best possible treatment choices. This problem is especially acute for children and infants at risk of harm from bacterial infections, many of which are increasingly resistant to antibiotic treatment. For this reason, maintaining a strong pipeline of safe and effective therapies is an urgent priority.

 

CTTI’s Peds Trials project, part of the larger Antibacterial Drug Development Program, is actively addressing these gaps and has created evidence-based recommendations designed to improve and streamline pediatric trial development and conduct. We hope you will join us in Chicago this Sept. 16-19 as we share new insights into challenges affecting pediatric trial enrollment, including reasons that parents refuse trials and provider perceptions of obstacles.

 

Poster & Podium Presentation: Obstacles to Pediatric Clinical Trial Enrollment: Why Parents Refuse; Findings from the Clinical Trials Transformation Initiative

Date & Time: Monday, Sept. 18, 12:35 p.m.–12:50 p.m. (oral presentation)

Monday, Sept. 18, 1:00 p.m.–5:00 p.m. (poster session)

Presenter: P. Brian Smith (Duke University)

 

Poster: Barriers to Pediatric Clinical Trial Enrollment: Findings and Recommendations from the Clinical Trials Transformation Initiative

Date & Time: Monday, Sept. 18, 1:00 p.m.–5:00 p.m. (poster session)

Presenter: P. Brian Smith (Duke University)

Improved Pregnancy Testing Planning for Safer, More Efficient Clinical Trials: Webinar Recording Now Available

Posted on by Lorri Bingham

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.

CTTI Presents Recommendations for Clinical Trial Pregnancy Testing Plans from CTTI on Vimeo.

 

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

Posted on by Lorri Bingham

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

Add to Calendar

CTTI Publishes Recommendations to Enhance Data Monitoring Committees

Posted on by Lorri Bingham

Improve trial oversight by applying best practices for DMC setup and operation

CTTI has published recommendations to enhance the functioning of data monitoring committees (DMCs) for clinical trials. Sponsors, DMC members, and all those involved in clinical trial design and conduct can apply CTTI’s recommendations to improve DMC operation and the quality of trial oversight, which ultimately benefits patients.

The monitoring of accumulating data in a clinical trial helps to ensure participant safety, as well as the validity and integrity of the trial. For an increasing number of trials, this is accomplished through an independent DMC that can advise on whether to continue, modify, or terminate a trial based on a benefit-risk assessment. Though DMCs play an important role in the oversight of clinical trials, there is considerable variability in how they are composed and operate.

CTTI’s recommendations, which appear in the journal Clinical Trials, address the following areas:

  • Clarifying the role of DMCs
  • Best practices for DMC conduct
  • Effective communication practices
  • Strategies for preparing the next generation of DMC members

The recommendations were developed through a consensus of experts from multiple stakeholder groups after collecting and analyzing data on DMC practices.

Learn more about CTTI’s Data Monitoring Committees Project.