Author: Lorri Bingham

Dr. Robert Califf to Speak on the Current State of Clinical Trials on the Path to Transformation

Posted on by Lorri Bingham

Robert Califf

Dr. Robert Califf, former Commissioner of the US Food and Drug Administration (FDA) and the Fortin Professor of Cardiology at the Duke University School of Medicine, will examine the current state of the clinical trials enterprise during a CTTI hosted webinar on Tuesday, March 14, at 12:00 p.m. Eastern Time.

ADD TO CALENDAR

During this webinar, Dr. Califf will address recent developments that have major implications for the clinical research enterprise in the United States, including the opportunities enabled by growing access to digital sources of data, the increasing importance of patient-reported outcomes, and the power of patient engagement in reshaping approaches to clinical research. As the recent head of FDA, Dr. Califf was directly involved in cross-agency efforts to modernize the national system for conducting clinical research by articulating a large, flexible, and widely shared approach to evidence generation (known as “EvGen”) that could leverage rapidly expanding sources of digital health data to produce high-quality, actionable information for patients and healthcare providers.

A particularly important aspect of these “EvGen” efforts hinges on effectively engaging patients and their advocates as partners in research, particularly as digital technologies and patient-reported outcomes data present new potential for the rapid and seamless acquisition of health data that is truly representative of broad and diverse populations. Ultimately, it is hoped that this new national research infrastructure will enable more rapid, representative, affordable, and generalizable clinical trials that can provide the high-quality evidence to enable a true learning health system. Many of these activities draw upon insights that were developed through pioneering investigations sponsored by CTTI, whose efforts will continue to shape national approaches to the creation and implementation medical knowledge.

Dr. Califf, who served as an original co-chair of CTTI and was instrumental in its creation, is a prominent cardiologist and clinical researcher whose career as a physician, teacher, researcher, and regulator spans more than three decades. Dr. Califf has provided leadership for numerous high-impact clinical trials and has been at the forefront of innovation in clinical research methods.

WEBINAR DETAILS:

This webinar is free and open to the public.
Meeting URL: https://dukemed.webex.com/dukemed/j.php?MTID=m62b866ad632870635fb7c4e690499fef
Meeting number (access code): 732 023 344
Meeting password: viewpoint

UPDATE: A RECORDING OF THIS WEBINAR IS NOW AVAILABLE ONLINE.

2016: A Year of Action at CTTI

Posted on by Lorri Bingham

ACTIONS SPEAK LOUDER THAN WORDS—SEE HOW CTTI IS MAKING A DIFFERENCE IN OUR RECENTLY RELEASED 2016 ANNUAL REPORT.

In 2016, we updated our mission statement to reflect an emphasis on driving the adoption of our recommendations into practice, and this shift was felt across our project portfolio.  For example,

  • We released tools to help organizations integrate recruitment planning throughout all stages of a clinical trial and to better engage all stakeholders, which can lead to increased clinical trial enrollment.
  • We delivered actionable recommendations for how to organize and conduct data monitoring committees to enhance the quality of clinical trial oversight.
  • To support organizations in adopting our early enrollment strategy for more feasible HABP/VABP trials, we enrolled >5,750 patients in a study to provide real-world evidence for this approach.

In addition to these achievements, CTTI’s work is being implemented at a variety of organizations across the clinical trial spectrum. In this annual report, learn how the Cystic Fibrosis Foundation, Eli Lilly, FasterCures, and UCB Pharmaceuticals are using CTTI’s work today.

We are proud of all that was accomplished last year with the active engagement of our members and others. Through collaborative efforts, we will continue to bring about more efficient and quality-driven clinical trials that deliver valuable evidence to improve the lives of patients.

“In this report, we detail CTTI’s 2016 successes confronting leading challenges, such as participant recruitment for clinical trials and a lagging pipeline for desperately needed new antibacterial therapies. In each priority area, we developed evidence-based, consensus-driven recommendations to fuel meaningful changes in medical product development, and we drove adoption of these approaches to make better clinical trials a reality.”

-Pamela Tenaerts, MD, MBA, Executive Director, CTTI

Public and Stakeholders Encouraged to Comment on Protocol for Innovative Clinical Trial

Posted on by Lorri Bingham

SENTINEL IMPACT-AFIB DRAFT PROTOCOL POSTED

The draft protocol for an innovative pragmatic clinical trial examining educational methods for improving medication utilization in patients with atrial fibrillation (AFib) has been posted on Sentinel Initiative website. This draft protocol is now available for public comment and feedback as part of process that seeks to engage all potential stakeholders in study development and implementation.

The Sentinel IMPACT-AFib study grew out of findings from a pilot program in which CTTI, through its Electronic Healthcare Data project, evaluated the feasibility of using data from FDA’s Sentinel System to conduct clinical trials. IMPACT-AFib marks the first time the Sentinel System has been used to support a randomized pragmatic clinical trial—not only by serving as a primary source for study data, but also by helping study organizers to identify potential participants.

Atrial fibrillation affects more than 5 million people in the United States. It is a serious condition in which the upper chambers of the heart beat with an irregular rhythm. More common among persons aged 65 years or older, AFib increases a person’s risk of stroke by up to five times and contributes to an estimated 130,000 deaths annually in the United States alone. Although AFib can be treated effectively with a number of different oral anticoagulant (OAC) medications, many of the people who stand to benefit from these therapies do not receive them.

Find out more about AFib and the background of the Sentinel IMPACT AFib trial by clicking here to access a CTTI webinar and slides.

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.

Navigating the Updated Common Rule

Posted on by Lorri Bingham

CTTI TOOLS AND RECOMMENDATIONS CAN HELP RESEARCHERS MEET NEW REQUIREMENTS FOR INFORMED CONSENT DOCUMENTS AND CENTRAL IRBS

This year the US Department of Health and Human Services released long-awaited updates to the Federal Policy for the Protection of Human Subjects, better known as the Common Rule. Originally issued in 1991, the Common Rule governs a large proportion of U.S. research involving human participants. CTTI offers resources and tools that can help investigators seeking to understand and implement some of these new requirements, including recommendations that closely parallel key Common Rule standards for informed consent documents and the use of central institutional review boards (central IRBs).

Informed Consent Documents

The revised Common Rule states that informed consent documents (ICDs) “…must begin with a concise and focused presentation of the key information” that is most likely to help prospective study participants understand the reasons for or against participating in a trial.  CTTI’s recommendations for using shorter, simpler informed consent documents that utilize a “tiered approach” to presenting information and incorporate health literacy and reading level assessments provide a structured path that can help in creating ICDs that satisfy Common Rule requirements:

SIMILARITIES BETWEEN COMMON RULE REQUIREMENTS & CTTI RECOMMENDATIONS FOR INFORMED CONSENT DOCUMENTS

New Common Rule Requirements for Informed Consent Documents (2017)CTTI Recommendations for Informed Consent Documents (2013)Concise and focused presentation of key information most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research.

Information in this part of the ICD must be organized and presented in a way that facilitates comprehension. Use of tiered approach, including:

  • Section that includes only elements required by federal regulations
  • Additional information in chapter format
  • 1-2 page summary of the study

Draft ICDs should be evaluated with:

  • Standardized health literacy/plain language assessments
  • Reading level assessments
  • Usability testing with comparable patients

Source: Federal Policy for the Protection of Human Subjects https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects Source: CTTI Recommendations: https://ctti-clinicaltrials.org/files/ctti-informedconsent-recs.pdf

Use of a Single or Central IRB

Another facet of the revised Common Rule that harmonizes with CTTI recommendations relates to the use of single IRBs for oversight of research activities in multicenter trials. In 2013, CTTI recommended the use of a central IRB (in other words, a single IRB of record for all research sites participating in a clinical study) in order to improve quality and efficiency. Although the Common Rule does not require all multisite trials to use a central IRB, it does mandate that U.S. institutions involved in cooperative research in the United States (with certain exceptions) use a single IRB and notes that

When working optimally, we expect the central IRB model will work more efficiently and require less personnel time and fewer resources for tracking and implementing IRB changes and approvals, thereby eliminating the potential for unnecessarily duplicative reviews.

CTTI offers several tools that can assist research sites, sponsors, and IRBs in successfully navigating the challenges of using a central IRB model, including a template IRB authorization agreement; an evaluation checklist that helps sites assess readiness, helps sites or sponsors select a central IRB, and helps central IRBs to assess research sites; and a considerations document that delineates the central IRB’s responsibilities versus the site’s institutional obligations.

 

For complete listings of publicly available CTTI implementation tools and recommendations, visit the CTTI website.

Webinar February 16: Improving Pediatric Antibacterial Drug Trials

Posted on by Lorri Bingham

Challenges in conducting antibacterial drug trials for pediatric patients can delay the safe and effective use of treatments for this vulnerable group.  There are now evidence-based, consensus-driven solutions. Are you ready to do better clinical trials for children?

Join us for a special webinar in which CTTI will unveil new recommendations for improving pediatric antibacterial clinical trials:

Add to Calendar

Title: CTTI Recommendations from the Antibacterial Drug Development (ABDD) Peds Trials Project
Date: February 16, 2016 12:00 – 1:00 PM EST (GMT-05:00)
Webinar Link: http://bit.ly/2kYGm7j
Speakers:

  • Sumathi Nambiar, U.S. Food and Drug Administration
  • John Bradley, University of California, San Diego
  • Gary Noel, Johnson and Johnson Pharmaceutical Research and Development

The webinar will include practical, evidence-based strategies that can be applied by research sponsors, investigators, and site staff to improve the quality and efficiency of pediatric antibacterial trials.

Learn these tips and more for making your trials more successful:

  • 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

Although developed in the context of antibacterial drug development, many of the recommendations can be applied to improve pediatric clinical trials in multiple therapeutic areas.

This webinar is open to the public. Please feel free to share this invitation with your colleagues.

Improve Electronic Portals for IND Safety Reporting With CTTI’s Recommendations

Posted on by Lorri Bingham

CTTI’s latest research indicates that a single, internet-based portal for investigator reporting of expedited IND safety information to sponsors would be better than the current system of each sponsor having a separate portal. However, until use of a central portal is feasible, the recently published findings and CTTI recommendations provide desired attributes that can promote consistent functionality across electronic portals, improving the quality and use of these systems.

Electronic portals can increase efficiency and lower costs associated with processing safety reports in clinical trials, as well as add an element of security. However, there can be challenges associated with use of these systems that prevent successful adoption. CTTI’s IND Safety Advancement Project sought to identify obstacles and to create recommendations for best practices for following FDA requirements and guidance on expedited safety reporting. Electronic portals are one method sites and sponsors can implement to help adhere to FDA requirements and improve the quality of safety reports.

The recommendations for electronic portals for IND safety reporting are based on results from interviews with research staff, along with multi-stakeholder input on how to address the challenges raised. For example, CTTI found that many research staff report difficulties in tracking multiple passwords and managing different interfaces for various sponsor portals. These research staff views helped to inform strategies that could decrease the burden of IND safety reporting in clinical trials.

For those in the clinical trials enterprise seeking to streamline IND safety reporting, additional recommendations are available from CTTI to improve IND safety assessment and communication.

Upgraded AACT Database Offers Improved Functionality for Analyzing ClinicalTrials.gov Data

Posted on by Lorri Bingham

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

Posted on by Lorri Bingham

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.