Innovative Trials

CTTI Seeks to Speed Use of Mobile Technology in Clinical Trials through Novel Endpoint Recommendations

Posted on by Lorri Bingham

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New CTTI Recommendations and Tools Equip Stakeholders to Integrate Mobile Technology into Clinical Trials

Mobile technologies hold enormous promise for clinical research, but uncertainty about how to use the data captured by these devices has slowed progress. CTTI’s newly released recommendations and tools aim to change this by providing a pathway for using information gathered from mobile technologies to accelerate the development and evaluation of urgently needed therapies.

Mobile technologies such as remote sensors and wearables can be used to make trials faster, more efficient, and more inclusive. They can also spare patients from burdensome clinic visits while capturing new kinds of data that offer a better picture of how patients experience their disease or condition in their daily lives.

“Technology-derived endpoints offer the benefit of capturing information about patients’ experience in ‘real-world’ settings,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “These tools have the potential to capture data that can be used to develop endpoints and evaluate therapies in the patient population.”

Responding to this potential, CTTI experts have crafted a set of recommendations and tools designed to help diverse stakeholders identify and develop novel endpoints based on data from mobile technologies for use in regulatory clinical trials.

“By engaging with experts who have been early champions of mobile technology in trials and combining that with patient insights, CTTI has created practical recommendations and action-oriented tools that have the potential to really accelerate the use of mobile technology in clinical trials,” noted Craig Lipset, Pfizer’s head of clinical innovation. “In particular, the use cases provide a realistic pathway for incorporating novel endpoints through technology into clinical development programs. CTTI’s recommendations show we may be closer than previously believed to realizing the benefits of these novel endpoints, creating a sense of urgency to act.”

In partnership with a group of investigators, regulators, patient representatives, technology developers, and research sponsors, four use cases were written to better guide the development and use of novel endpoints as part of clinical trials for Parkinson’s disease, heart failure, diabetes, and Duchenne muscular dystrophy.

“The Michael J. Fox Foundation was pleased to participate in CTTI’s efforts to develop novel mobile endpoints for use in clinical trials,” said Lauren Bataille, senior associate director of research partnerships at the Foundation. “We look forward to leveraging these assets to support Parkinson’s research collaborations and speed the developments of measures that matter to patients.”

CTTI’s Novel Endpoints recommendations are the first to be released as part of a larger body of work to address multiple challenges to using mobile technology in clinical trials. CTTI’s Mobile Clinical Trials Program includes additional projects on legal and regulatory considerations, stakeholder perceptions, and scientific and technical issues related to the use of mobile devices. Recommendations from these projects will follow over the next year.

Click here to view more information on CTTI’s Novel Endpoints Project.

To view a recording of the webinar that unveiled these recommendations, click here.

Accelerating the Use of Mobile Technology In Clinical Trials: Webinar Recording Now Available

Posted on by Lorri Bingham

EXPERTS UNVEIL NEW RECOMMENDATIONS AND TOOLS FOR INTEGRATING NOVEL ENDPOINTS DERIVED FROM MOBILE TECHNOLOGY INTO CLINICAL TRIALS

Mobile technologies are reshaping the landscape of clinical trials and making it possible to capture new kinds of patient data. Learn how novel endpoints derived from these technologies can be leveraged for more efficient, less burdensome clinical trials that generate the high-quality data needed to address the outcomes that matter most to patients.

In this webinar, a group of expert presenters and panelists describe CTTI’s new recommendations and tools for identifying and developing technology-based novel endpoints and incorporating them into clinical trials. Drawn from backgrounds spanning academia, industry, technology development, patient advocacy, and regulatory agencies, CTTI’s expert stakeholders provide a “guided tour” of these resources. They also discuss key strategies—including early engagement and discussion with regulators—for successfully integrating novel endpoints into clinical trials that enable a better understanding of the effects of diseases and their treatments on patients’ daily lives. CTTI’s MCT Novel Endpoints recommendations, which were developed from a multi-stakeholder expert meeting that applied four “real-world” use cases (heart failure, diabetes, Parkinson’s disease, and Duchenne muscular dystrophy), address the following key areas:

  • Identifying and developing high-quality novel endpoints that best reflect patients’ priorities and needs
  • Selecting the best outcome measures and matching those measures with appropriate technologies
  • Developing products that address unmet needs and adapting solutions that meet the demands of the clinical research and patient care environments
  • Supporting trial sponsors and researchers in working effectively with regulators to develop evidence-based, high-quality novel endpoints that can be used to support regulatory review and approval

FOR MORE INFORMATION ON THIS WEBINAR, INCLUDING POWERPOINT SLIDES, PRESENTER INFORMATION, AND MORE, CLICK HERE.

The MCT Novel Endpoints Project is part of CTTI’s larger Mobile Clinical Trials Program.

Webinar June 26: Launching New CTTI Recommendations to Accelerate the Appropriate Use of Mobile Technology in Clinical Trials

Posted on by Lorri Bingham

CTTI Webinar

Mobile technologies offer unique opportunities for making clinical trials faster, more efficient, and more representative of actual patient experiences. By addressing unmet needs for quality outcome measures, enabling more efficient alternatives to traditional clinical research models, and reducing dependence on data that represent only a tiny snapshot of patients’ experience of disease, mobile technologies allow us to capture new kinds of information while reducing the burdens of trial participation. However, realizing these benefits requires a clear understanding of how to successfully select, develop and incorporate technology-derived novel endpoints and incorporate them into clinical trials—a need that CTTI is addressing through its MCT Novel Endpoints Project.

Join us for a special webinar in which CTTI will present new recommendations and tools to support the selection, development, and inclusion of technology-derived novel endpoints in clinical trials.

ADD TO CALENDAR

Topic: Developing novel endpoints generated using mobile technology for use in clinical trials
Date: Monday, June 26, 2017 12:00 – 1:30 PM EDT (GMT-04:00)
Webinar Link: http://bit.ly/2rAJ9K7
Presenters:

  • Martin Landray (University of Oxford)
  • Marc Walton (Janssen)

Panel members sharing their perspectives on adoption of the recommendations:

  • Leonard Sacks (US Food and Drug Administration)
  • Lauren Bataille (Michael J. Fox Foundation)
  • Wendy Snyder (Amgen)
  • Rob Wilson (ActiGraph)

The webinar will include a first look at evidence-based approaches and tools that can be applied by research sponsors, investigators, technology developers, and patient groups to facilitate the use of novel endpoints derived from mobile technology in clinical trials. You will learn about a set of tools developed by CTTI’s expert stakeholders to guide the identification, development and inclusion of appropriate novel endpoints.

Our presenters and panel members will show how:

  • The clinical research enterprise can benefit from the appropriate inclusion of technology-derived novel endpoints in clinical trials
  • Sponsors and investigators can work effectively with regulators to develop high-quality novel endpoints to support regulatory submission and approval
  • Patient groups can both drive the identification of novel endpoints that measure symptoms that matter and participate in their development
  • Tech developers can better match product development to unmet needs and adapt solutions for the demands of clinical trials and the patient care environment
  • Stakeholders can collaborate to avoid common pitfalls in the development process

You will be introduced to four “real-world” use cases that shaped the development of these tools and recommendations, with key lessons to be carried forward to other therapeutic areas. You will also learn how these tools and recommendations can be applied in practice from our panel of early adopters.

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

New CTTI Recommendations Provide Path for More Efficient Clinical Trials Using Clinical Registries

Posted on by Lorri Bingham

Registry Trials

CTTI’s newly released recommendations have the potential to streamline clinical trials by using registry information. Registries are data collection tools typically used to better understand long-term trends in a specific population, such as patients with a particular disease or patients exposed to a certain treatment.

“High-quality registries are an increasingly important source of evidence for regulatory decisions and surveillance, conveying important information, for example, regarding real-world medical product use and outcomes throughout the total product lifecycle,” said John Laschinger, MD, of the U.S. Food and Drug Administration, who helped lead the CTTI work. “Use of high-quality registries as a vehicle for efficient conduct of randomized clinical trials is a proven concept that can be considered for future pre-market trials,” he added.

If registries are designed appropriately, the “real-world” data within them should often be able to meet the expectations of regulatory agencies, and support decisions about medical products. In this regard, CTTI addresses how to assess data quality, ensure patient protections, and link with other data sources. The recommendations apply to both existing and new registries. Following these best practices can assist in evaluating suitability of registry data for regulatory purposes.

“Conducting randomized clinical trials within registries can increase efficiencies in data collection and decrease site workload, potentially leading to significant cost savings,” said Sunil Rao, MD, principal investigator of the successful randomized registry-based clinical trial, SAFE-PCI for Women.

While the scope of this project was limited to registries, many of the principles and tools in these recommendations have the potential to be applied to using health care systems or other existing data sources, such as those available within claims databases, to facilitate more efficient clinical trials.

More information about these recommendations on conducting clinical trials using registries is available both on the Registry Trials Project page and in a webinar recording.

 

*To view the press release of this announcement, click here.

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.

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.

Expert Meeting Materials Now Available: Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical

Posted on by Lorri Bingham

View Expert Meeting MaterialsOn September 29-30, 2016, CTTI hosted a multi-stakeholder expert meeting to begin to develop recommendations for how to develop mobile technology–derived novel endpoints for use in clinical trials. Mobile technologies such as remote sensors have the potential to facilitate continuous, high-quality data acquisition not typically possible with traditional data collection methods. However, it is currently unclear how data from these devices may be used to generate novel endpoints for use in clinical trials.

Meeting attendees drafted four use cases to clarify the pathway for developing novel endpoints derived from data captured using mobile devices:

  • Use of accelerometers to measure treatment benefit in heart failure, Parkinson’s disease, and muscular dystrophy trials
  • Use of continuous glucose monitors to measure treatment benefit in diabetes trials

Highlights from this meeting are now available in the meeting summary. As a next step in the MCT Novel Endpoints Project, the team will use the evidence from these four use cases, along with findings from a systematic review that is underway, to inform general recommendations to help promote widespread adoption of mobile technologies in clinical trials.

Meeting attendees included investigators, patient representatives, engineers, algorithm experts, regulators, nonprofit consortia, and statisticians who had experience with the diseases and/or devices discussed.

Recording Now Available: Transforming Pragmatic Clinical Trials with Sentinel IMPACT-AFib

Posted on by Lorri Bingham

Would you like to learn how FDA’s Sentinel System is being used for the first time to conduct a randomized clinical trial?

A recording is now available of CTTI’s webinar discussing Implementation of a Multicenter Clustered Randomized Controlled Trial to imProve Treatment with AntiCoagulanTs in Patients with Atrial Fibrillation (IMPACT-AFib). The concept for IMPACT-AFib stemmed from a collaboration between CTTI and Sentinel (formerly Mini-Sentinel) on the Uses of Electronic Healthcare Data Project to evaluate the use of Sentinel for conducting randomized trials. Sentinel has the potential to reduce the time and costs of participant enrollment and follow-up compared with conventional clinical trials.

About 5 million people in the United States have atrial fibrillation, and roughly 1 in 5 strokes are due to this condition, representing a significant health burden. While anticoagulation therapy is effective for stroke prevention in this population, only about half of these patients receive this therapy according to guidelines.

The proof-of-concept IMPACT-AFib trial will use the Sentinel System to assess the ability of an educational intervention to increase anticoagulation use in at-risk patients with atrial fibrillation. The webinar discusses considerations encountered in planning for this pragmatic trial:

  • Identifying eligible patients and treatments received using a distributed database with linkage to pharmacy claims
  • Conducting a pilot phase
  • Engaging data partners, providers, and patients in study development
  • Making decisions regarding randomization and informed consent

WE INVITE YOU TO VIEW THE RECORDING, ALONG WITH THE PRESENTATION SLIDES, TO LEARN MORE ABOUT THIS EXCITING TRIAL AND THE USE OF SENTINEL TO IMPROVE CLINICAL TRIALS.

To view recordings of other CTTI webinars, CLICK HERE.

Webinar Recording Available: Global Expert Panel on Antibacterial Drug Development

CTTI News | September 15, 2016

Topics Included: Data Collecting and Reporting, Ensuring Quality, Innovative Trials, Regulatory Submissions + Approvals

On August 24, 2016, CTTI hosted a webinar on innovative approaches to transforming antibacterial drug development as recently featured in a Clinical Infectious Diseases (CID) supplement. The presentation highlighted the important role public-private partnerships play in advancing the field of antibacterial drug development and included an inside look at CTTI’s two new sets of recommendations for streamlining HABP/VABP trials. Thought leaders from CTTI, FDA, industry, and academia spoke, reflecting on the significance of this new body of work.

We are now pleased to share the webinar recording, in which you can hear more about:

  • Use of an evidence-based approach to characterize the challenges of studying new antibacterial drugs
  • Actionable solutions to these challenges developed from collaborations between multiple stakeholders
  • Ongoing work to determine the promise and potential implications of an early enrollment strategy for HABP/VABP trials

Learn more about CTTI’s Streamlining HABP/VABP Trials Project and Antibacterial Drug Development Program.

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