CTTI News

CTTI Leads Workshop and Shares Findings at International Meeting on Clinical Trials

Posted on by Lorri Bingham

LOOK FOR US AT SCT ICTMC 2017 IN LIVERPOOL FOR STRATEGIES TO IMPROVE THE QUALITY AND EFFICIENCY OF CLINICAL TRIALS

You’re headed to Liverpool, take this printable one page schedule of CTTI’s presentations at the meeting. See you there!

CTTI will present its recommendations and latest findings in five sessions at the International Clinical Trials Methodology Conference (ICTMC) and Society for Clinical Trials (SCT) Annual Meeting, May 7-10, 2017. We will lead a hands-on workshop on best practices for Data Monitoring Committees, and share our evidence and strategies on embedding randomized clinical trials within registries, developing novel endpoints generated by mobile technology, and more.

Session Title: Formative Research Findings on the Design of an Early Enrollment Clinical Trial on Hospital Acquired Bacterial Pneumonia (HABP) and Ventilator Associated Bacterial Pneumonia (VABP) (Parallel Session 1.5 – Qualitative Research)
Date & Time: Monday May 8 from 1:30–2:30 p.m.
Speaker: Amy Corneli, Duke University
Related CTTI Project: HABP/VABP Studies

Post/our-work/novel-clinical-trial-designs/antibiotic-drug-development/abdd-habp-vabp-studies/er Abstract: Embedding Randomized Clinical Trials within Registries: How Feasible? (Poster Board #152)
Date & Time: Monday, May 8 from 3:40–4:25 p.m.
Speaker: Ted Lystig, Medtronic
Related CTTI Project: Registry Trials

Poster Abstract: Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials: A Clinical Trials Transformation Initiative (CTTI) Project (Poster Board #153)
Date & Time: Monday, May 8 from 3:40–4:25 p.m.
Speaker: Martin Landray, University of Oxford
Related CTTI Project: MCT Novel Endpoints

Workshop Title: Data Monitoring Committees: Multi-stakeholder Recommendations and Hands-on Experience from CTTI and the MRCT Center (Workshop 3)
Date & Time: Tuesday, May 9 from 8:30–10:00 a.m.
Speaker: Annemarie Forrest, CTTI
Related CTTI Project: DMCs

Panel: Clinical / Outcomes Registry-Based Randomised Controlled Trials – The Future for Clinical Trials? (Invited Session 3.5)
Date & Time: Tuesday, May 9 from 8:30–10:00 a.m.
Speaker: Ted Lystig, Medtronic
Related CTTI Project: Registry Trials

Update on CTTI’s Mobile Devices Project: Webinar Recording Now Available

Posted on by Lorri Bingham

CTTI Team Leaders Provide Update on Project Exploring how Mobile Technology Can Be Effectively Leveraged to Improve Clinical Trials

Mobile technologies, including both medical sensors and consumer products, offer exciting new possibilities for clinical research but present substantial challenges as well. Find out how CTTI’s Mobile Devices team is exploring how these technologies can be used to improve patient engagement, remote monitoring, and the collection of new kinds of high-quality, objective data capable of supporting rigorous analysis and regulatory submission.

In a webinar now available as a recording on the CTTI website, project team leaders Cheryl Grandinetti (FDA), Chris Miller (AstraZeneca), and Barry Peterson (Philips) provide an update on CTTI’s Mobile Devices Project, which focuses on scientific and technological challenges affecting the selection and use of mobile technologies in clinical research. The presenters share preliminary evidence gathered from research sponsors and clinical investigators experienced in using mobile devices in clinical trials. Issues addressed in the webinar include:

  • Challenges affecting data management, validation, analysis, and security in mobile technologies;
  • Scientific and technical considerations in mobile device selection; and
  • Approaches to managing and reporting safety signals and adverse events.

After additional evidence and insights from this project are gathered, the team will release recommendations designed to help overcome challenges that are currently hindering the wider use of mobile technologies in clinical trials.

The Mobile Devices Project is one of four distinct efforts taking place through CTTI’s larger Mobile Clinical Trials Program. The MCT Program is developing evidence-based recommendations to guide the widespread adoption and application of mobile technologies in clinical trials. The three other projects within the program are focused on:

  1. Legal and regulatory issues
  2. Development and use of novel endpoints for use with mobile technologies
  3. Stakeholder perceptions regarding the use of such technologies

CLICK HERE to view recordings of other CTTI-hosted webinars.

CTTI Welcomes Six New Members

Posted on by Lorri Bingham

CTTI is pleased to welcome its newest members. CTTI actively engages all stakeholders equally to collaboratively improve the quality and efficiency of the clinical trials enterprise. These organizations bring diverse viewpoints to help CTTI develop solutions with real-world impact.

  • Alpha-1 Foundation: nonprofit promoting research for Alpha-1 Antitrypsin Deficiency
  • Amici Clinical Research: clinical research center in New Jersey associated with a family practice treating 15,000 active patients.
  • Boehringer Ingelheim: global, research-driven pharmaceutical company.
  • Cystic Fibrosis Foundation: nonprofit and world leader in the search for a cure for cystic fibrosis.
  • inVentiv Health: global provider of healthcare & pharma consulting to biopharmaceutical clients.
  • Novartis: global healthcare company that provides solutions to address the evolving needs of patients worldwide.

CTTI now has more than 80 member organizations and several individual patient/caregiver representatives. Learn more about our diverse membership.

Webinar Recording Now Available: Clinical Trials on the Path to Transformation

Posted on by Lorri Bingham

 

Former FDA Commissioner Dr. Robert Califf Offers a Glimpse of the Future of Clinical Research

The U.S. clinical research enterprise is undergoing enormous changes. Find out how new technologies, research methods and regulations are converging to reshape national approaches for generating evidence to guide healthcare decisions.

In a webinar now available as a recording on the CTTI website, Dr. Robert Califf offers his insights on the ongoing transformation of clinical research in the era of “omics,” big data, and activated patients. Drawing on his experience as a clinician, researcher, and most recently, head of the FDA, Dr. Califf surveys the current landscape of clinical trials, which despite incremental improvements are beset by rapidly rising costs and still fall short in providing the kinds of high-quality evidence needed by clinicians, patients, and policymakers.

However, he also notes that recent advances in technology, research methods, and patient engagement, further accelerated by provisions in the 21st Century Cures Act and the Food and Drug Administration Safety and Innovation Act (FDASIA), can provide the key elements needed to enable a more effective and efficient learning health system. These include:

  • Continuous engagement with patients as active participants throughout the entire research process
  • Innovation in approaches that can accommodate enormous quantities of biological information while also leveraging newly accessible “real-world data” to complement more conventional research methods
  • Development of networks that enable secure data sharing and bidirectional learning
  • Adoption of common standards for data storage, transfer and curation
  • Renewed focus on streamlining of processes for clinical trials that promote efficiency and remove barriers

CLICK HERE to view the presentation slides and additional info.

CTTI Publishes Findings on Stakeholder Perceptions of IND Reporting Process in Oncology Trials

Posted on by Lorri Bingham

CTTI has published its findings on remaining barriers and potential solutions to full implementation of the FDA final rule on IND safety reporting by investigators, clinical research staff, and sponsors.

In 2010, the FDA final rule established new reporting requirements for serious and unexpected suspected adverse events occurring in clinical trials conducted under an IND. Follow-up FDA guidance clarified sponsors’ role and that they should not submit expedited safety reports for individual cases of serious adverse events for which it does not appear the drug caused the event. It was anticipated that these changes could increase the interpretability of safety reports while decreasing the volume and burden of reporting.

Through a series of surveys and interviews, the results of which were published in the journal Clinical Trials, CTTI discovered that while all groups agreed on the intention of the final rule in increasing early communication of safety signals, they also indicated that the rule was not being strictly implemented. Interviewees reported that the major challenges included lack of global harmonization in reporting rules, difficulties determining causality, and fear of regulatory repercussions, some of which could be improved with increased interaction with the FDA itself.

These findings, which resulted from CTTI’s IND Safety Reporting Project, support recommendations developed by CTTI and underpin educational materials created for sponsors to increase compliance with the final rule, and to facilitate discussion between sponsors, investigators, and FDA representatives. CTTI gathered input on these findings and their impact in a multi-stakeholder expert meeting (a meeting summary is available for additional context) and hosted a webinar to provide guidance on handling a variety of safety reporting situations.

CTTI would like to thank the interview participants and project team members who contributed to this work.

CTTI Examines Investigator Turnover in New Paper

Posted on by Lorri Bingham

Learn About Issues Affecting the Supply of Experienced and Engaged Trial Investigators

Clinical trials work best when experienced investigators conduct research activities. But chronically high rates of investigator turnover mean that a substantial proportion of FDA-regulated drug trials are led by clinicians who step forward to conduct a trial, but then do not go on to conduct other trials—so-called “one and done” investigators. This has serious implications, because investigator turnover is associated with higher costs and greater levels of inefficiency for clinical trials.

To get a clearer picture of what factors are driving this turnover and how it affects the investigator community, CTTI researchers surveyed clinicians about factors affecting their decisions to conduct only one FDA-regulated drug trial. Using the federal Bioresearch Monitoring Information System (BMIS), which contains data on physicians who have submitted forms required for participation in FDA-regulated trials (the “Form FDA 1572”), they identified investigators who had conducted only one FDA-regulated trial (including trials that were still ongoing) at the time of the survey. They were particularly interested in learning what kinds of barriers to continued participation these investigators were encountering and which ones had the most impact on their decision to conduct only one FDA-regulated drug trial.

Figure 1The CTTI group’s findings, which have been published in the journal Contemporary Clinical Trials Communications, show that a little over half of the roughly 200 investigators who participated in the survey did not plan to take part in any further FDA-regulated drug trials. Among this group, the reasons given for not wishing to participate further in such trials differed substantially according to whether the survey participants were academic or non-academic/community-based clinicians. More “one and done” academic investigators indicated they were no longer participating because of a lack of available trials, while “one and done” community investigators were more likely to cite personal choice as the reason for not participating.

Although the investigators surveyed acknowledged a wide variety of barriers to participating in FDA-regulated drug trials, several broad categories were identified across most investigators:

  • Time requirements and difficulty in balancing workloads
  • Burdens imposed by data and safety reporting
  • Problems with different aspects of trial finances

The survey results revealed high rates of investigator turnover for FDA-regulated drug trials among the study participants; they also provide details and insights into the reasons that site investigators stop conducting such studies. This study was done as part of a larger CTTI project that focuses on strengthening the community of clinical investigators. Work is now underway on extending the findings from this preliminary survey to create a better understanding of the factors that influence clinicians’ decisions to participate as investigators in multiple FDA-regulated drug trials.

Learn more about CTTI’s Strengthening the Investigator Site Community Project.

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.