Author: Lorri Bingham

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.

Improved Pregnancy Testing Planning for Safer, More Efficient Clinical Trials: Webinar Recording Now Available

Posted on by Lorri Bingham

Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk. However, there is little formal guidance on how pregnancy testing should be conducted to prevent unintended exposure, nor how risks should be clearly communicated to women.

CTTI’s new recommendations help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials. CTTI also created the Pregnancy Testing Outcomes Predictor for Clinical Trials, a web application that provides a quantitative method for assessing estimated likely outcomes of different pregnancy testing plans.

A webinar recording is now available detailing the new recommendations and web application, including case examples of their use.

CTTI Presents Recommendations for Clinical Trial Pregnancy Testing Plans from CTTI on Vimeo.

 

View the webinar recording to learn:

  • Steps involved in proactive planning for pregnancy testing before the start of a clinical trial
  • A new web application to help assess the balance of benefits and burdens of specific pregnancy testing plans
  • Ways study coordinators can improve communication so that women receive clear, comprehensive information before joining a clinical trial
  • How these new recommendations promote the safe inclusion of women in clinical trials

Visit this page for presenter information and to download a copy of the slides.

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.

Coming soon: How improved pregnancy testing planning can lead to safer, more efficient clinical trials

Posted on by Lorri Bingham

CTTI shares new pregnancy testing plan recommendations and an online tool in an upcoming free public webinar

Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk. In an upcoming webinar, CTTI will unveil new recommendations and an online tool to help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, to conduct safer, more efficient clinical trials.

Attend this webinar to learn:

  • Steps involved in proactive planning for pregnancy testing before the start of a clinical trial
  • A new online application to help assess the balance of benefits and burdens of specific pregnancy testing plans
  • Ways study coordinators can improve communication so women receive clear, comprehensive information before joining a clinical trial
  • How these new recommendations promote the safe inclusion of women in clinical trials

Webinar: CTTI Presents Recommendations for Clinical Trial Pregnancy Testing Plans
Date & Time: Thursday, August 24, 2017 12:00–1:00 p.m. ET (GMT-04:00)
Presenters:

  • Claire Jurkowski, MD, former medical director, Global Pharmacovigilance and Epidemiology, Bristol-Myers Squibb (Retired)
  • Jessica Morse, MD, MPH, assistant professor, University of North Carolina School of Medicine
  • Evan Myers, MD, MPH, professor, Duke University Medical Center

Add to Calendar

Getting Down to the Bottom Line: The Financial Impact of Patient Engagement in Clinical Trials

Posted on by Lorri Bingham

CTTI publishes framework for estimating the impact of patient engagement on key business drivers

To fully realize the impact of patient engagement in clinical trials, there is a need for robust and rigorous study of its quantitative effects on research and development. To begin to address this gap, CTTI recently published an approach for assessing the financial value of patient engagement that accounts for the business drivers of cost, risk, revenue, and time.

In a set of recommendations published along with the financial model, CTTI’s Patient Groups & Clinical Trials Project team outlines “rules of engagement” for successful collaborations between research sponsors and patient groups around clinical research. Together, the articles in Therapeutic Innovation & Regulatory Science (TIRS) provide a blueprint for establishing effective patient group engagement in research programs.

While research sponsors are increasingly partnering with patients in the design and conduct of clinical development programs, sponsors may be reluctant to go beyond pilot initiatives because of uncertainty in the return on investment. The new CTTI article describes a novel approach to quantifying the financial impact of patient-centric initiatives using risk-adjusted financial modeling techniques that integrate key business drivers into a summary metric (expected net present value). Expected net present value (ENPV) is a widely used metric by industry for project strategy and portfolio decisions.

Drawing on published data to develop a case study for a typical oncology development program, the authors also show how patient engagement activities that avoid a protocol amendment or improve the patient experience can contribute considerable financial value.

Ongoing work by CTTI’s Patient Groups & Clinical Trials Project is examining how sponsors and patient groups characterize the benefits of patient engagement and investments required for engagement. Along with the ENPV model, the project aims to provide resources to assist in determining which of the many engagement opportunities provide the greatest value.

Strengthening the Investigator Site Community

Posted on by Lorri Bingham

Gain new insights into challenges affecting investigator retention and potential solutions

Evidence shows that the pool of qualified clinical investigators in the United States is shrinking, while at the same time a high percentage of investigators are likely to stop leading trials after conducting just a single drug study—trends that threaten the quality and efficiency of U.S. regulatory trials.

On April 5, 2017, CTTI convened an expert meeting to explore this issue and others related to clinical trial investigator turnover and retention. A comprehensive meeting summary presents survey and interview data gathered from current and former trial investigators and explores approaches that can help investigators overcome the practical challenges of conducting clinical trials.

CTTI’s Investigator Community Project was created to better understand why some clinical investigators remain actively engaged in clinical research but others decide to leave it after a single experience. CTTI is applying these insights to develop strategies that can improve investigator retention and reduce turnover, ultimately leading to more efficient, higher-quality clinical trials. The multi-stakeholder project team will continue to review evidence and incorporate consensus findings from the expert meeting as it develops recommendations and other products that can be used to strengthen the investigator community.

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.

CTTI Advances Mobile Clinical Trials & Patient Engagement at DIA 2017

Posted on by Lorri Bingham

Driving insights to action with our latest findings

CTTI Schedule at DIA 2017At this year’s DIA Annual Meeting, CTTI will present new approaches that can help bring the use of mobile technology in clinical trials from promise to reality. Advancements in data capture with mobile technology can translate to improved clinical trial quality and efficiency. CTTI will share case examples and methods for addressing specific challenges of integrating mobile devices into clinical trials in four presentations. These are preliminary results from CTTI’s Mobile Clinical Trials Program.

In addition, we will share our latest findings on measuring the financial impact of patient engagement from the Patient Groups & Clinical Trials Project. If you’ve been searching for a way to help sponsors and patient groups speak the same language in terms of perceived value of collaboration, this is the presentation for you. It is widely accepted that patient engagement can add value to the research process, but when it comes to business decisions, sponsors may be reluctant to allocate resources to patient engagement without a measure of financial impact. We present financial modeling for the impact of patient engagement to help inform these decisions.

DIA 2017 will be held in Chicago from June 18-22 and is themed “Driving Insights to Action.” Please join us for CTTI’s presentations:

Presentation: At the cornerstone of wearable technology and patient-focused clinical trial endpoints (#227)
Date & Time: Tuesday, June 20, 2017 from 10:30-11:45 a.m.
Presenters: Leonard Sacks, Nikunj Patel, Robert DiCicco, Ray Dorsey
Related CTTI Projects: MCT Novel Endpoints & Mobile Devices

Presentation: Generating novel endpoints through mobile technology: A promising and realistic new approach to trial design (#244)
Date & Time: Tuesday, June 20, 2017 from 2:00-3:15 p.m.
Presenter: Robert DiCicco
Related CTTI Project: MCT Novel Endpoints

Presentation: Getting down to the nitty-gritty: Addressing the specific challenges of electronic data and mobile devices in clinical trials (#308)
Date & Time: Wednesday, June 21, 2017 from 10:30-11:30 a.m.
Moderator: Jonathan Helfgott; Presenter: Jennifer Goldsack
Related CTTI Project: MCT Mobile Devices

Presentation: Getting down to the bottom line: Measuring the financial impact of patient engagement (#316)
Date & Time: Wednesday June 21, 2017 from 10:30-11:45 a.m.
Presenter: Bennett Levitan
Related CTTI Project: Patient Groups & Clinical Trials

Presentation: Straight from the horse’s mouth: Lessons learned from legal & regulatory challenges of real remote trials (#366)
Date & Time: Wednesday, June 21, 2017 from 4:00-5:15 p.m.
Presenter: Gerrit Hamre
Related CTTI Project: MCT Legal & Regulatory

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.