Digital Health Trials Hub

CTTI Examines Stakeholder Perceptions of Mobile Clinical Trials: Latest Expert Meeting Summary Now Available

Posted on by Lorri Bingham

The use of mobile technology holds the promise for higher quality, more efficient clinical trials, allowing remote participation in study activities, reducing patient burden, and facilitating the involvement of a more diverse population.

Critical to the widespread adoption of mobile technology in clinical trials is positive reception by key stakeholders. However, until recently, very little was known about the possible benefits and barriers perceived by investigators and trial participants. To address this issue, CTTI conducted qualitative and quantitative research to better understand perceptions, and reviewed the findings in a multi-stakeholder expert meeting (see one-page summary) that included investigators, patient partners, regulators, technology experts, sponsor representatives, and other groups.

At the meeting, experts underscored that successful adoption of mobile technology requires

rethinking how trials are designed and conducted. At the same time, they noted that many of the factors that define high-quality trial design remain the same, whether or not mobile technology is used. They also agreed on:

  • The importance of involving patients early and often in trial planning and design;
  • Ensuring that participants remain engaged and are able to easily communicate with site staff;
  • Selecting and tailoring devices based on study design; and
  • Addressing the unique concerns that stakeholders have around mobile clinical trials, including patient confidentiality, missing or inaccurate data, maintaining patient engagement, and a lack of uniformity among processes, devices, and platforms.

As a next step, the CTTI MCT Stakeholder Perceptions Project team will use the findings from this meeting to inform the development of recommendations for designing and conducting trials with mobile technology to best meet the needs of patients and sites.

Finding Solutions to Legal and Regulatory Challenges of Conducting Mobile Clinical Trials

Posted on by Lorri Bingham

Mobile clinical trials (MCTs) offer several potential advantages, such as greater patient convenience, efficiencies in data collection, potential for novel endpoints, and enhanced participant retention.

However, despite the successful conduct of several MCTs for regulatory submission, the MCT model has yet to be widely adopted. This is due in part to presumed legal and regulatory issues in the U.S., such as the complexity of navigating different state medical licensing laws, patient and investigator oversight, and issues with the drug supply chain of custody.

In July 2017, CTTI convened a multi-stakeholder expert meeting to explore the legal and regulatory challenges inhibiting more widespread practice of MCTs, and to identify potential solutions. A meeting summary is now available highlighting main points from the discussion, including the following:

  • Highly varied state laws and regulations need to be thoroughly understood and recorded in an accessible location, e.g., a public database.
  • Guidance from regulatory bodies is needed to define principal investigators’ responsibilities regarding patient care oversight and potential delegation of activities,
  • Trials with a mobile clinical component should not be held to higher standards than traditional trials.
  • Patients and regulatory agencies should be engaged in trial design early in the development phase.

CTTI’s MCT Legal and Regulatory Project team will leverage themes and specific solutions from the multi-stakeholder discussions to develop recommendations and tools that will help address legal and regulatory challenges currently associated with MCTs.

 

This work is part of CTTI’s MCT Program, which is also exploring other topics and barriers related to planning for and conducting MCTs.

CTTI Update: Advancing the Use of Mobile Health Technology to Transform Clinical Trials

Posted on by Lorri Bingham

Mobile technology has the potential to revolutionize clinical trials, but putting mobile clinical trials (MCTs) into action requires consideration of issues such as data integrity, legal and regulatory barriers, scientific and technological challenges, and perspectives of potential trial participants, investigators, and site staff. For the past two years, CTTI’s MCT Program has systematically explored barriers to MCTs, gathered evidence, and convened multiple stakeholders to tackle these issues.

By developing best practices on how to effectively integrate mobile technologies into clinical trials for regulatory submissions, CTTI intends to promote quality, efficient, and more cost-effective research. Recent developments include the following:

  • CTTI’s Recommendations for Developing Novel Endpoints Generated by Mobile Technology for Use in Clinical Trials were released in June and are prominently featured in a recent mHealth Action Plan from the Duke-Margolis Center for Health Policy.
  • CTTI’s recommendations are accompanied by several practical tools and case examples that describe the process of novel endpoint development for MCTs.
  • A survey of potential research participants, as well as in-depth interviews with site investigators on issues related to MCTs, are underway. Analysis of these results will begin this fall and will inform recommendations to overcome barriers to the use of mobile technology in clinical trials as perceived by key stakeholders.
  • CTTI presented “Turning Opportunity Into Reality: Real Data and Practical Guidance for Incorporating Mobile Technology in Clinical Trials” at the DPharm Disruptive Innovations Conference in September 2017. The presentation included—as it relates to mobile technology—the patient perspective, tips for dealing with large volumes of data, and engaging with the FDA during trial design, execution, and monitoring.
  • Two expert meetings were held in 2017, one on legal and regulatory issues and one on scientific and technological challenges affecting MCTs. Official CTTI recommendations and resources on these topics will be issued in early 2018

CTTI Advances Mobile Clinical Trials at DPharm 2017

Posted on by Lorri Bingham

Mobile technology has been used in a variety of ways, but it has yet to be widely incorporated into clinical trials—despite its great potential to increase trial quality and efficiency. As part of its Mobile Clinical Trials (MCT) Program, CTTI has implemented four projects to identify and address the challenges related to planning for and conducting clinical trials that use mobile technology. This week, CTTI will present strategies and insights from the program at DPharm 2017 Conference, held in Boston on September 6-8.

At the 2-day conference themed “Disruptive Innovations US,” CTTI will bring together key industry leaders who are collaborating on recommendations for the use of mobile technologies in regulated clinical trials after the point of informed consent. This will include—as it relates to mobile technology—the patient perspective, tips for dealing with large volumes of data, and engaging with the FDA during trial design, execution, and monitoring.

Presentation: Turning Opportunity Into Reality: Real Data and Practical Guidance for Incorporating Mobile Technology in Clinical Trials
Date & Time: Friday, Sept. 8, 2:30–3:10 p.m.
Moderator: Komathi Stem (monARC Biotech)
Panelists: Ray Dorsey (University of Rochester), Cindy Geoghegan (Patient and Partners), and Gary Grabow (Genentech)

Also, at DPharm’s pre-conference program, “Mobile in Clinical Trials,” CTTI will share recommendations that clarify the pathway for developing novel endpoints from data generated using mobile technology in clinical trials.

Presentation: CTTI Findings Are in From Their Mobile Clinical Trials Program: Recommendations on Novel Endpoints
Date & Time: Wednesday, Sept. 6, 9:20–9:40 a.m.
Presenter: Jennifer Goldsack (CTTI)

In addition to Novel Endpoints, CTTI is also working on recommendations to address challenges and opportunities related to Mobile Devices, Legal and Regulatory, and Stakeholder Perceptions, as part of the MCT Program.

Addressing Challenges of Using Mobile Devices in Clinical Trials

Posted on by Lorri Bingham

Mobile devices hold great potential to transform clinical trials by their ability to capture objective, real-world health data directly from study participants. While this technology shows promise to improve the quality and efficiency of medical product development, questions remain on how to successfully integrate mobile devices for data capture into clinical trials.

On June 16, 2017, CTTI convened a multi-stakeholder expert meeting to further refine solutions to the scientific and technological challenges preventing widespread adoption of mobile devices in clinical trials. A meeting summary is now available, including the following:

  • The recommended best practices for studies using mobile devices for data capture do not differ significantly from many of the best practices that we already apply to clinical trials.
  • Studies using mobile devices for data capture should not be held to higher standards than traditional trials.
  • Efforts to leverage mobile devices for data capture should strive to engage patients in study design and endpoint selection.

The MCT Mobile Technologies Project focuses on using mobile devices in FDA-regulated clinical trials after initial participant consent—in other words, the use of devices for data capture rather than for recruitment, retention, or as the study intervention. The project team will use findings from the expert meeting to develop recommendations and tools that guide the adoption of mobile devices for data capture in clinical trials.

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

Posted on by Lorri Bingham

Novel Endpoints Recs Banner

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.

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.

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.