Ensuring Quality

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.

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.

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.

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.

Webinar Recording Now Available: CTTI Recommendations for Improving Pediatric Antibacterial Drug Trials

Posted on by Lorri Bingham

Do you struggle with enrolling babies and children in clinical trials? Are you tired of not having the evidence you need to treat kids with serious infections?

A recording is now available of CTTI’s webinar discussing the new CTTI recommendations on improving antibacterial drug trials for children. Experts from FDA, academia, and pharma described the challenges of conducting pediatric antibacterial drug trials, along with practical, evidence-based strategies to improve the quality and efficiency of these trials. These strategies were developed with input from multiple stakeholders and can be used by research sponsors, investigators, and site staff to make pediatric trials more successful.

View the recording to learn ideas on how you can create better clinical trials for children, such as:

  • Importance of engaging with regulators early and throughout medical product development
  • Methods of streamlining trial design to decrease burden on sites and families
  • Special considerations for conducting trials with neonates
  • Approaches for improving the informed consent process
  • Ways to increase engagement with healthcare providers

 

These recommendations are a result of CTTI’s ABDD Peds Trials Project.

To view recordings of other CTTI webinars, click here.

CTTI Releases New Recommendations to Improve Studies of Antibacterial Drugs for Children

Posted on by Lorri Bingham

CTTI has released new recommendations to improve the quality and efficiency of research studies used to develop antibacterial drugs for children. In addition, many of the suggested strategies and practices could be applied to streamline clinical trials of other types of drugs and medical devices for children.

“Medically, children are not just little adults, and they need access to treatments that have undergone appropriate evaluation for safety and efficacy in children,” said Daniel Benjamin Jr., MD, PhD, MPH, a pediatric infectious diseases specialist at Duke University. “The CTTI recommendations address many of the common challenges of conducting this research, and if applied widely, can help deliver much-needed information and treatments to benefit our young patients.”

These recommendations resulted from a collaborative effort among research sponsors, parents, investigators, clinicians, and regulators from the US and the EMA (European Medicines Agency), who provided practical suggestions for the timing of pediatric trials, streamlining trial design, facilitating informed consent, and fostering global and community partnerships to conduct trials that can improve children’s health.

The time from approval of a new antibacterial drug for use in adults to pediatric labeling can be 5 years or longer, potentially delaying appropriate use of medicines for this vulnerable group. Antibacterial resistance is on the rise in children, and the very young can be particularly susceptible to severe illness or death from these pathogens. Despite the great need for more treatment options, many trial sponsors have challenges enrolling pediatric patients in antibacterial drug trials.

“These recommendations encourage consultation with the FDA on pediatric study plans early in drug development and emphasize the potential utility of global study networks and streamlining trials,” said Sumathi Nambiar, MD, MPH, Director of the Division of Anti-Infective Products at the U.S. Food & Drug Administration (FDA). “Our mutual goal is to provide data in the drug labeling that will better inform the safe and effective use of antibacterial drugs in children.”

The CTTI recommendations are meant to  help researchers design trials that are less burdensome for families, as well as to support  improved practices for approaching parents for consent during the stressful time of a child’s illness. These recommendations are based on research that showed 80% of clinicians surveyed identified parent concerns about their child participating in research to be a barrier for completing research studies with children. This emphasizes the need for better engagement with parents throughout a clinical trial, including during the initial design stage. “This work matters to the lives of families like mine,” said Breck Gamel, a parent participant in the CTTI effort. CTTI studied other clinician concerns as well, which helped to identify educational gaps in pediatric labeling and the need for better engagement with other healthcare providers.

*These recommendations are the result of CTTI’s ABDD Peds Trials Project.

**To read this press release in full, click here.