Innovative Trials

Webinar Now Available: CTTI’s New Recommendations for Engaging Patients and Sites in Mobile Trials

Posted on by Lorri Bingham

A recording is now available of the public webinar on Thurs., Feb. 21, to launch CTTI’s new recommendations for incorporating patient and site perspectives in mobile clinical trials. The webinar was led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.

CTTI conducted qualitative and quantitative research to better understand the perceptions of patients and site personnel, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.

“Patients are attracted to the possibilities of greater convenience and greater access to clinical research—fewer visits, less time away from work and family, and less burden on their caregivers,” Geoghegan said. “Our goal was to enhance the experience for both patients and hard-working site staff.”

The resulting recommendations are designed to help research sponsors engage patient and site perspectives in planning mobile trials, maximize value and minimize burden for study participants, and address challenges for investigative sites.

“One of the key messages is the importance of planning,” Nido said. “We are new to this as an industry, and we need to plan for and address these new challenges in order to maximize the benefits of mobile technology in clinical trials.”

This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for using decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.

CTTI Unveils New Recommendations for Incorporating Patient and Site Perspectives in Mobile Trials

Posted on by Lorri Bingham

CTTI released new recommendations and resources today for engaging patients and sites when planning clinical trials using mobile technologies. These recommendations have the potential to help sponsors, CROs, and other stakeholders gain the full benefits of using mobile technologies in clinical trials, including remote participation, increased protocol adherence, and participation by a more diverse population.

While buy-in from stakeholders is critical to the success of mobile trials, little was known about patient and site perspectives until CTTI conducted surveys and interviews with patients and investigative site personnel to assess perceived benefits and barriers.

Engaging Patients and Sites Recommendations

The resulting recommendations have the potential to help research sponsors:

  • Engage patients and sites in protocol design, technology selection, and pilot testing
  • Maximize value and minimize burden for study participants by setting patient expectations, protecting privacy, returning data, enhancing patient-site interactions, and providing technical support
  • Address challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training

“CTTI’s recommendations and resources are designed to take our understanding of patient and site needs in mobile clinical trials to the next level,” said Bill Wood, associate professor at the School of Medicine at the University of North Carolina at Chapel Hill. “With these new insights, sponsors and researchers can plan and conduct mobile trials that work better for everyone involved, streamlining the clinical research process and accelerating the development of critical new therapies.”

The recommendations are the fourth set generated through CTTI’s Mobile Clinical Trials (MCT) Program, following recommendations on developing novel endpoints generated by mobile technologies, using mobile technologies for data capture in clinical trials, and planning and conducting decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patients Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.

CTTI to Launch Recommendations for Engaging Patient and Site Perspectives in Mobile Clinical Trials

Posted on by Lorri Bingham

CTTI will host a public webinar on Thurs., Feb. 21, to announce new recommendations and resources for incorporating patient and site perspectives when planning and conducting mobile clinical trials.

“Acceptance and adoption by key stakeholders is critical to the widespread use of mobile technologies in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “However, very little was known about patient and sites’ perspectives until our work shed light on what they see as significant benefits and barriers. Our new recommendations account for these perspectives and provide a valuable resource for optimally deploying mobile clinical trials.

“Further, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design. Engaging these groups early and often is the key to running better trials.”

CTTI conducted surveys and in-depth interviews to better understand the perceptions of patients and clinical investigators, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.

The resulting recommendations are designed to assist research sponsors in:

  • Engaging patient and site perspectives in planning clinical trials using mobile technologies, including protocol design, technology selection, and pilot testing
  • Maximizing value and minimizing burden for study participants, including setting patient expectations, protecting privacy, returning individual data, enhancing patient-site interactions, and providing technical support
  • Addressing challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training

This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for planning and conducting decentralized clinical trials.

The free webinar will begin at noon ET and will be led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.

CTTI Article Finds that Patients and IRBs are Amenable to Early Enrollment Strategy

Posted on by Lorri Bingham

A CTTI article recently published in JAMA Network Open shows that an early enrollment strategy for research on healthcare-associated pneumonia is acceptable to patients, investigators, and institutional review boards (IRBs). This strategy has the potential to speed enrollment in trials for critical new antibiotic therapies by allowing patients to be approached and consented to before being diagnosed with pneumonia.

Through its ABDD HABP/VABP Studies work, CTTI conducted qualitative interviews with 52 stakeholders—including patients at risk for pneumonia, caregivers, study investigators and coordinators, and IRB representatives—as part of formative research to assess the acceptability of the approach.

The study found that patients and caregivers had no concerns about patients being approached early and having their records monitored before they developed pneumonia. They believed that patients would be able to understand consent information before diagnosis, and shared their preferences for opt-out procedures.

IRB representatives were also supportive of an early enrollment strategy, and investigators and study coordinators indicated that the approach would not be burdensome.

New CTTI Recommendations Offer Path Forward for Decentralized Clinical Trials

Posted on by Lorri Bingham

CTTI released new recommendations on overcoming the legal, regulatory, and practical hurdles for planning and conducting decentralized clinical trials (DCTs) today during the DPharm: Disruptive Innovations to Advance Clinical Trials conference in Boston, Mass.

 

DCTs, which are run through telemedicine and mobile health care providers, offer several potential advantages, such as faster recruitment, improved retention, greater control and convenience for participants, and increased participant diversity. CTTI’s evidence-based and practical recommendations address barriers—including varying state medical licensing laws and issues with the drug supply chain of custody—that could be hindering the widespread use of DCTs.

 

The recommendations also offer guidance on effective DCT protocol design, investigator delegation and oversight, use of mobile health care providers, and safety monitoring. A key concept within the recommendations is that DCTs do not have to be fully decentralized, but can incorporate various procedures and activities that are common in traditional studies.

 

This is the third set of recommendations from CTTI’s Mobile Clinical Trials Program for FDA-regulated trials, which aims to drive the adoption of mobile technologies in an effort to improve the efficiency and quality of clinical trials. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in July, it unveiled new solutions for using mobile technologies for data capture in clinical trials. Recommendations addressing patient and investigator engagement regarding the use of mobile technologies in clinical trials will be released in early 2019.

Special Launch Event Recap: Using Mobile Technologies for Data Collection in Clinical Research

Posted on by Lorri Bingham

Experts Unveil New CTTI Recommendations and Resources at FDA’s White Oak Campus

During a daylong launch event at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, more than 100 people—along with hundreds of virtual attendees—learned about CTTI’s newly release recommendations and resources for the use of mobile technologies in clinical trials.

The evidence-based recommendations and resources outline best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.

More than 30 technology and clinical trials experts participated in sessions offering practical guidance, from selecting a mobile technology through to preparing for FDA submission and inspection. The event concluded with a lively panel on “The Future of Mobile Technologies in Clinical Trials,” where five leaders shared valuable reflections and predictions:

 

“A lot of what was discussed today is very much in line with the EMA’s position—the ‘rules’ are the same with data from mobile clinical trials and traditional trials, patient input is critical, and regulators should be engaged from the start of, and throughout a trial.” – Francesca Cerreta, European Medicines Agency

“One of the things I’m most excited about is that mobile technologies bring studies to participants, versus participants having to come to studies. And there’s opportunity to gather more pre- and post-intervention information than ever before.” – Ray Dorsey, University of Rochester

 

“There is a lot of interest in using mobile technologies in clinical trials and their potential to improve the quality and efficiency of clinical trials. This meeting is another step forward in exploring ways to incorporate mobile technologies into regulated clinical trials. I’m very encouraged by the sense of optimism from the many different sectors represented here today.” – Leonard Sacks, FDA

Pat Furlong, Parent Project Muscular Dystrophy, and John Hubbard, Genstar Capital, also joined Cerreta, Dorsey, and Sacks on the panel. They noted that CTTI’s new recommendations open the door to new opportunies for clinical tirals including improved patient engagement, better quality of data, and lower costs.

CTTI Unveils Recommendations for Using Mobile Technologies in Clinical Research

Posted on by Lorri Bingham

New Recommendations and Resources Provide Road Map for Using Mobile Technologies for Data Capture in Clinical Research

 

In a special event today at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, CTTI unveiled new recommendations for the use of mobile technologies in clinical research. The evidence-based recommendations and resources address an unmet need by outlining best practices for the use of mobile devices and applications to capture objective data—an approach that has the potential to increase the quality and efficiency of clinical trials.

 

“The clinical research community has long discussed an exciting future of using mobile technologies to collect objective, reliable data in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “Today, we are excited to start making this vision a reality—sharing recommendations for capturing more informative real-world data from patients, reducing barriers to trial participation, and lowering costs associated with conducting clinical trials.”

 

The full set of recommendations and resources includes case examples and decision tools that offer practical guidance for:

 

  • Selecting mobile technologies for data capture that are appropriate to the trial.
  • Capturing complete, attributable, and high-quality data.
  • Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
  • Designing and executing a protocol that uses mobile technologies for data capture.
  • Preparing for FDA submission and inspection.

 

This is the second set of recommendations from CTTI’s Mobile Clinical Trials Program for FDA-regulated trials. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies. Later this year, recommendations will be released addressing patients’ and investigators’ needs regarding the use of mobile technologies in clinical trials and overcoming challenges to conducting decentralized trials in the U.S.

Watch Live from FDA’s White Oak Campus: CTTI Unveils Mobile Technologies Recommendations

Posted on by Lorri Bingham

Are you interested in transforming clinical trials by using mobile technologies for data capture? A clear road map for making this vision a reality is now here.

 

Watch live as leaders in clinical trials and mobile technologies unveil CTTI’s new Mobile Technologies recommendations from the U.S. Food and Drug Administration’s (FDA) White Oak Campus. Throughout the day, attendees will hear insights and practical guidance for:

 

  • Selecting mobile technologies for data capture that are appropriate to the trial.
  • Capturing complete, attributable, and high-quality data.
  • Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
  • Designing and executing a protocol that uses mobile technologies for data capture.
  • Preparing for FDA submission and inspection.

ADD TO CALENDAR

 

The event will culminate with an engaging panel discussion on the future of mobile technologies in clinical trials. Panelists will include Francesca Cerreta of the European Medicines Agency; Ray Dorsey of the University of Rochester Medical Center; Pat Furlong of Parent Project Muscular Dystrophy; John Hubbard of Genstar Capital; and Leonard Sacks of the FDA.

 

Join Us at the FDA’s White Oak Campus for CTTI’s Mobile Technologies Event

Posted on by Lorri Bingham

Thank you for your interest in CTTI’s Mobile Technologies Event. As of June 8, seating is full for this event. We hope you can join us for the live stream from FDA’s White Oak Campus on July 16.

 

The use of mobile technologies for data capture has the potential to transform clinical trials. What has been missing is a clear road map for making this vision a reality. This will change on July 16.

Leaders in clinical trials and mobile technologies will gather for a special event at the U.S. Food and Drug Administration’s (FDA) White Oak Campus, where CTTI will unveil its new Mobile Technologies recommendations. Representatives from the multi-stakeholder group of experts who developed the recommendations will offer insights and practical guidance throughout the day.

The event will culminate with an engaging panel discussion on the future of mobile technologies in clinical trials. Panelists will include Francesca Cerreta of the European Medicines Agency; Ray Dorsey of the University of Rochester Medical Center; Pat Furlong of Parent Project Muscular Dystrophy; John Hubbard of Genstar Capital; and Leonard Sacks of the FDA.

MORE INFORMATION

  • Date and Time: Mon., July 16, 2018; 9:30 a.m. – 5:00 p.m. (Add to Calendar)
  • Location: FDA, White Oak Campus,  Silver Spring, Md.

Objectives:

  • Selecting mobile technologies for data capture that are appropriate to the trial.
  • Capturing complete, attributable, and high-quality data.
  • Managing the data generated by mobile technologies—including safety considerations, data integrity, and security issues.
  • Designing and executing a protocol that uses mobile technologies for data capture.
  • Preparing for FDA submission and inspection.

Visit the project webpage to view the full set of Mobile Technologies recommendations and resources.