Digital Health Trials

New CTTI Article Investigates Mobile Device Use to Measure Outcomes in Clinical Research

Posted on by Lorri Bingham

A CTTI article recently published in Digital Biomarkers investigates the use of mobile devices to measure outcomes in clinical research from 2010-2016. The article provides a detailed accounting of where the field is currently, allowing researchers to see what measures exist for using or developing technology-derived endpoints, how they are being used, and how to access relevant literature.

The review found that, while mobile devices are widely used to assess outcomes in observational research, their use in interventional research is limited. Additionally, the absence of standardization across the measures used to assess outcomes of interest, units of measurement, sampling rate, device placement, and the technologies themselves indicates a pressing need for standards to interpret and compare results across studies and across therapeutic areas.

The article offers suggestions for incorporating mobile technology into interventional research—such as consolidating evidence supporting the clinical meaningfulness of specific technology-derived endpoints, and standardizing the use of mobile devices in clinical research to measure these endpoints.

The review also found that:

  • The majority of technology-derived novel endpoints are currently being used in cardiac studies. However, in randomized controlled trials, technology-derived novel endpoints are most commonly used in Type I diabetes studies.
  • Physical activity measures are the most commonly used technology-derived endpoints in clinical studies. Other commonly used endpoints are related to sleep, mobility, and pill adherence, as well as biomarkers such as cardiac, glucose, gastric reflux, respiratory measures, and intensity of head-related injury.
  • There is a scarcity of technology-derived measures being used as actual outcome assessments in studies of neurological diseases such as Parkinson’s and Alzheimer’s, which have a considerable unmet need for measures. Oncology and nephrology are two other key therapeutic areas with unmet need for better assessments, but a dearth of technology-derived measures.

CTTI Shares New Insights on Early Enrollment, Barriers to Remote Clinical Trials, and Improving Investigator Trainings at PRIM&R Advancing Ethical Research Conference

Posted on by Lorri Bingham

CTTI will present findings during three sessions at the upcoming PRIM&R Advancing Ethical Research (AER) Conference.

On Mon., Nov. 6, CTTI will share data on stakeholder perceptions of early informed consent and enrollment in clinical trials. While early enrollment could improve the ability to conduct trials that evaluate the efficacy and safety of treatments for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), questions remain about implementing it ethically and effectively. CTTI will share findings from its HABP/VABP Studies Project on the acceptability of an early informed consent approach for high-risk patients and essential information that should be shared with key stakeholders.

On Wed., Nov. 8, CTTI will discuss findings from its MCT Legal & Regulatory Project on actual and perceived barriers that may be preventing the widespread use of mobile technology in clinical trials. Presenters will explore potential challenges and opportunities of conducting clinical research remotely, and solicit input from clinical enterprise stakeholders on potential ethics implications. The project is part of CTTI’s Mobile Clinical Trials (MCT) Program.

In a separate session, CTTI will also present findings to date for its Investigator Qualification project and Investigator Community recommendations. The presenter will examine whether current GCP training methods actually provide the knowledge and skills necessary to conduct quality clinical trials. Further, he will detail recently released recommendations that aim to strengthen the clinical trials investigator and study team community through better training and other approaches.

We hope you will join us in San Antonio, Texas, Nov. 5-8 as we share new insights into these noteworthy clinical trials topics.

Presentation: Stakeholder Perceptions on Early Informed Consent for Clinical Trials
Date & Time: Mon., Nov. 6, 3:30 – 4:45 p.m.
Presenters: Amy Corneli (CTTI) and Thomas Holland (Duke University)

Presentation: Clinical Trials Transformation Initiative (CTTI) Mobile Clinical Trials, Legal, and Regulatory Project
Date & Time: Wed., Nov. 8, 11:15 a.m. – 12:30 p.m.
Presenters: David Babaian (Kinetiq), Linda Coleman (Yale University), and Jan Hewett (FDA

Presentation: Beyond Good Clinical Practice (GCP) Training: Expanding the Tool Set for Preparing Investigators
Date & Time: Wed., Nov. 8, 11:15 a.m. – 12:30 p.m.
Presenters: Gerrit Hamre (CTTI)

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.

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.