CTTI News

CTTI Shares Latest Findings on Mobile Technology, Patient Engagement, and More at DIA 2018

Posted on by Lorri Bingham

At this year’s DIA 2018 Global Annual Meeting, CTTI will share insights across a broad range of topics that are core to its mission of enhancing the quality and efficiency of clinical trials. During the event, which will take place in Boston from June 24-28, CTTI will take part in 10 different presentations and sessions in areas ranging from patient-focused medical development to the use of mobile technology for data capture to quality approaches to clinical trial design.

 

Please join us at the CTTI exhibitor booth (#1624) and attend our presentations:

 

Presentation: The Metamorphasis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials
Date & Time: Mon., June 25, 11:00 a.m. – 12:00 p.m.
Presenters:  Angela Botto-van Bemden (Arthritis Foundation)
Related CTTI Project: MCT Stakeholder Perceptions

 

Presentation: Patient-Focused Medicines Development: Where It Has Led Us Today, What Challenges Remain and What Do We Still Need to Do to Achieve Success?
Date & Time: Mon., June 25, 11:00 a.m. – 12:15 p.m.
Presenter: Pamela Tenaerts (CTTI)

Related CTTI Projects: Patient Groups & Clinical Trials

 

Presentation: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials
Date & Time: Mon., June 25, 11:00 a.m. – 12:15 p.m.

Chair: Robert DiCicco (TransCelerate Biopharma)
Presenters:  Philip Coran (Medidata Solutions), Cindy Geoghegan (Individual Patient/Caregiver), and Jan Hewett (FDA/CDER)
Related CTTI Project: MCT Mobile Technologies

 

Engage & Exchange Session: New Approaches, Novel Endpoints, and Next-Generation Trials
Date & Time: Mon., June 25, 1:45 – 2:45 p.m.

Chair: Jennifer Goldsack (CTTI)
Facilitators: Jessie Bakker (Philips Respironics), Daniel Karlin (Pfizer), and Komathi Stem (monARC Bionetworks)

Related CTTI Project: MCT Novel Endpoints

 

Presentation: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative
Date & Time: Mon., June 25, 3:00 – 4:15 p.m.

Chair: Annemarie Forrest (CTTI)
Presenters: Sabrina Comic-Savic (The Medicines Company) and Julie Dietrich (Amgen)
Related CTTI Project: Quality by Design

 

Content Hub: Developing Standards to Support the Use of Wearables and Sensors for Objective Data Collection During Clinical Trials
Date & Time: Tues., June 26, 1:30 – 2:00 p.m.
Presenter: Jennifer Goldsack (CTTI)
Related CTTI Project: MCT Mobile Technologies

 

Presentation: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers

Date & Time: Tues., June 26, 4:15 – 5:30 p.m.

Chair: Jane Myles (Genentech – a member of the Roche group)
Presenters: Gerrit Hamre (CTTI), Leonard Sacks (FDA/CDER), and Komathi Stem (monARC Bionetworks)
Related CTTI Project:  MCT Mobile Technologies, MCT Novel Endpoints

 

Presentation: Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials

Date & Time: Tues., June 26, 4:15 – 5:30 p.m.
Presenters: Sunil Agarwal (HCL America) and James Streeter (Oracle)
Related CTTI Project: MCT Data Collection

 

Presentation: Redefining the Site Investigator’s Experience

Date & Time: Tues., June 26, 4:15 – 5:30 p.m.
Presenters: Kaitlin Malone (Amgen)

Related CTTI Project: Investigator Community

 

Presentation: Data and Quality Approaches to Informing Global Investigative Site Selection

Date & Time: Wed., June 27, 8:00 – 9:15 a.m.

Chair: Stella Stergiopoulos (Tufts Center for the Study of Drug Development)
Presenter: James Kremidas (ACRP)
Related CTTI Project: Investigator Qualification

 

Poster: Effective Engagement Between Sponsors & Patient Groups: A Structured Process and Use Cases from CTTI

Date & Time: Wed., June 27, 9:30 – 10:30 a.m., 12:00 – 2:00 p.m., 3:00 – 4:00 p.m.

Presenter: Zach Hallinan (CTTI)

Related CTTI Project: Patient Groups & Clinical Trials

CTTI Welcomes NIH Leader to Executive Committee and Extends Terms of Three Current Members

Posted on by Lorri Bingham

Jodi BlackrCTTI is pleased to announce the addition of a leader in the National Institutes of Health’s (NIH) research initiatives to its Executive Committee, as well as the renewal of the appointments of three current members.

New EC member Jodi Black is the deputy director of the NIH Office of Extramural Research, where she oversees and supports initiative development, grants management policy and processes, and the small business and extramural technology development programs.

“CTTI’s work relies on input, participation, and collaboration across a range of public and private stakeholders in clinical research and development,” said CTTI Executive Director Pamela Tenaerts. “Jodi’s passion for challenging the status quo, as well as her experience building strategic alliances between academia, healthcare, and industry, will be invaluable to furthering CTTI’s efforts and advancing our mission to improve the efficiency and quality of clinical trials.”

CTTI is also delighted to extend the terms of current members Hans-Georg Eichler of the European Medicines Agency (until Dec. 31, 2020), Dalvir Gill of TransCelerate BioPharma Inc. (until Dec. 31, 2019), and Louis Jacques of ADVI (until Dec. 31, 2018).

“We are grateful for the continued commitment of Hans-Georg, Dalvir, and Louis, and excited for the valuable expertise Jodi brings to our committee,” said CTTI Executive Committee Chair Mark McClellan. “I’m confident that their leadership and insight will significantly contribute to the overall direction and strategy of CTTI and its impact on clinical research.”

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. 

CTTI Hosts Free Webinar to Highlight Key Initiatives of MDIC to Advance Medical Device Regulatory Science

Posted on by Lorri Bingham

CTTI will host a free, public webinar on Thurs., May 17, at 12:00 p.m. EDT to highlight key initiatives of the Medical Device Innovation Consortium (MDIC), a public-private partnership working to advance medical device regulatory science. Attendees will learn how MDIC’s and CTTI’s efforts—particularly around engaging patients as equal partners and driving single IRB adoption—complement each other to improve clinical trials.

 

Add to Calendar

 

Stephanie Christopher and Dan Schwartz of MDIC will present on topics including:

 

  • The Science of Patient Input initiative to develop a framework for patient input in clinical trials.
  • A preview of results from the project to integrate patient preferences into the design of clinical trials.
  • Early Feasibility initiative to highlight Early Feasibility Study (EFS) Metrics and Contract projects.

CTTI has long recognized that overcoming the complex challenges facing the clinical trials enterprise requires strong coordination across initiatives. By ensuring our enterprise-wide efforts are complementary and not duplicative, we can more efficiently and successfully improve the R&D process and increase the quality and efficiency of clinical trials.

 

Topic: MDIC and CTTI: Synergies in Clinical Trials Efforts

Date: Thurs., May 17, 2018, 12:00-1:00 p.m. EDT (GMT -04:00)

Presenters: Stephanie Christopher and Dan Schwartz (MDIC)

CTTI Celebrates Clinical Trials Day at SCT Annual Meeting

Posted on by Lorri Bingham

CTTI will commemorate Clinical Trials Day (which will be celebrated on May 21 this year) by leading a number of presentations at the Society for Clinical Trials (SCT) Annual Meeting May 20-23 in Portland, Ore. CTTI will discuss its findings on using mobile technologies for data capture, selecting and developing novel endpoints for use in clinical research, incorporating real-world evidence in randomized clinical trials, and more.

CTTI Executive Director Pamela Tenaerts will also share lessons learned since CTTI’s inception in 2007 and reflect on 10 years of transforming the clinical trials enterprise. See a full schedule of CTTI presentations below.

Poster: Selecting, Developing and Incorporating Technology-Derived Novel Endpoints into Clinical Trials

Date: Mon., May 21, 3:30-4:00pm

Related CTTI Project: MCT Novel Endpoints

Poster: One Decade of Impact. One Vision Ahead. Optimizing the Power of Public-Private Partnership: Lessons Learned from the Clinical Trials Transformation Initiative

Date: Tues., May 22, 3:30-4:00 p.m.

Poster: Use of Qualitative Data Analysis Software to Facilitate a Systematic Literature Review

Date: Tues., May 22, 10:15-10:45 a.m.

Related CTTI Project: MCT Novel Endpoints

Presentation 1: The Challenges and Opportunities of Mobile Technology: A Qualitative Examination of Investigators’ Experiences and Recommendations

Presentation 2: Mobile Technology and Clinical Trials: Patient Perspectives and Opportunities to Reduce the Burden of Participation

Date: Wed., May 23, 9:30-10:30 am

Presenter: Virginia Nido (Genentech – a member of the Roche Group)

Related CTTI Project: MCT Stakeholder Perceptions

Presentation: Designing Study Protocols When Mobile Devices Are Used for Data Capture: Recommendations from the Clinical Trials Transformation Initiative

Date: Wed., May 23, 9:30-10:30 am

Presenter: Tom Switzer (Genentech – a member of the Roche Group)

Related CTTI Project: MCT Mobile Technologies

Presentation: Understanding the Clinical Trial Enterprise’s Newest Trend: Incorporating Real-World Evidence into Randomized Clinical Trials

Date: Wed., May 23, 9:30-10:30 am

Presenter: Scott Evans (SCT)

Related CTTI Project: Real-World Data

CTTI Releases 2017 Annual Report: One Decade of Impact. One Vision Ahead.

Posted on by Lorri Bingham

CTTI’s 2017 Annual Report, released today, celebrates a decade of CTTI impact and highlights our activities and accomplishments over the past year. The report includes reflections from past and present CTTI leaders, case studies on the use of CTTI recommendations and resources, and a glimpse into what lies ahead for CTTI and the clinical trials enterprise.

Since its founding in 2007, CTTI has completed more than 25 projects with the aim of increasing the quality and efficiency of clinical trials. The resulting recommendations were downloaded more than 26,000 times over the past year.

CTTI issued five new sets of recommendations in 2017, many of which draw on recent advances in technology and data sciences to bring about improvements for clinical trials. Read the report to learn more about our latest recommendations and resources, which offer:

As described in the report, these recommendations and resources are being implemented by organizations across the clinical trial spectrum, including IQVIA, monARC Bionetworks, and the Pulmonary Fibrosis Foundation.

As we reflect on the past year—and the past decade—we are grateful for the engagement and commitment of our members, who ensure that we continue to address the latest trends, top barriers, and leading opportunities in clinical research.

Two Patient Advocates Join CTTI Executive Committee

Posted on by Lorri Bingham

CTTI is pleased to announce the addition of two experienced patient advocates to its Executive Committee:

Donna Cryer is the CEO of the Global Liver Institute, which promotes innovation and fosters collaboration to improve the health of patients with liver disease.

Pat Furlong is the founder and CEO of Parent Project Muscular Dystrophy, which works to end Duchenne muscular dystrophy by accelerating research and advocating for optimal patient care.

“CTTI recognizes the importance of meaningful patient engagement in both our organizational structure and project work, and in the broader clinical trials enterprise,” said CTTI Executive Director Pamela Tenaerts. “We are excited for Donna and Pat to serve on our Executive Committee and ensure that the patient voice is represented in decisions regarding CTTI’s direction and strategy.”

As members of the Executive Committee, Cryer and Furlong will offer valuable perspectives in driving toward CTTI’s vision of a high-quality clinical trials system that is patient-centered and efficient. They bring decades of experience in patient and caregiver advocacy in the nonprofit sector. Both have served as advisers and consultants to government agencies, professional societies, and advocacy organizations.

“CTTI’s mission to increase the quality and efficiency of clinical trials is achievable when we have the broadest range of stakeholders at the table,” said CTTI Executive Committee Chair Mark McClellan. “Donna and Pat will strengthen our ability to promote patient and caregiver engagement across the clinical trials enterprise.”

The two new CTTI Executive Committee members join a distinguished group of thought leaders with the knowledge and experience to make meaningful improvements in clinical research.

Donna CryerPat Furlong

    Donna Cryer                      Pat Furlong

CTTI to Offer Insights on Investigator Qualification, Mobile Technologies, and Other Opportunities in Clinical Research at ACRP 2018

Posted on by Lorri Bingham

The ACRP 2018 education and networking event will feature three presentations from CTTI highlighting evidence-based strategies for enhancing clinical trial quality and efficiency. The event will take place in National Harbor, Md., from April 27-30.

On Sat., April 28, CTTI Executive Director Pamela Tenaerts will join leaders across the clinical trials enterprise to discuss collaborative initiatives to improve clinical research, including investigator qualification, quality by design, the use of mobile technologies, and more.

The following day, CTTI will share findings from its Investigator Qualification Project, which explores how best to ensure the efficient and effective qualification of site investigators and their delegates for the quality conduct of clinical trials. In a recent ACRP article, presenter Janette Panhuis of PHRI underscores the importance of CTTI’s work to move the clinical trials enterprise toward more meaningful investigator training.

On Mon., April 30, CTTI will discuss outcomes of in-depth interviews with investigators who have conducted both traditional clinical trials and studies using mobile technologies, providing insights on the advantages and disadvantages to be aware of when running a trial with mobile technology, budgetary and training needs, and other important factors for investigative site personnel to consider. Read more about CTTI’s MCT Stakeholder Perceptions Project.

We hope you will be able to join us at ACRP 2018. Please visit the CTTI Events page for more information about these and other upcoming CTTI presentations.

Presentation: Meet the Changemakers: Driving Clinical Research Quality Through Collaborative Leadership

Date & Time: Sat., April 28, 8:00 – 9:00 a.m.

Presenters: Pamela Tenaerts (CTTI), Patricia Leuchten (The Avoca Group), Douglas Peddicord (Association of Clinical Research Organizations), and Andy Lee (Merck)

Presentation: Defining Quality in Clinical Trial Conduct and Preparing Investigators for Success: Findings from CTTI’s Investigator Qualification Project

Date & Time: Sun., April 29, 11:30 a.m. – 12:30 p.m.

Presenters: Sabrina Comic-Savic (The Medicines Company), Bridget Foltz (FDA), Janette Panhuis (PHRI), and Diana Foster (ACRP)

Presentation: Investigator Perspectives and Insights on the Use of Mobile Tech in Clinical Trials: Findings from CTTI’s Mobile Clinical Trials Project
Date & Time: Mon., April 30, 9:30 – 10:30 a.m.

Presenters: Steve Morin (FDA) and Virginia Nido (Genentech, a member of the Roche Group)

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.

CTTI Explores How to Prepare Qualified Investigators and their Delegates: Latest Expert Meeting Summary Now Available

Posted on by Lorri Bingham

Although good clinical practice (GCP) training has long been considered the industry standard for ensuring investigators are qualified for the high-quality conduct of clinical trials, little evidence has been collected to determine whether it actually provides the knowledge and skills to equip investigators and their delegates to conduct clinical trials.

To address this issue, CTTI convened an expert meeting in December 2017 to discuss action that can be taken to inform the efficient and effective qualification of site investigators and their delegates. The meeting (see one-page summary) included representatives from pharmaceutical companies, government, research sites, contract research organizations, patient representatives, and other groups.

Meeting participants collaborated to refine a draft framework defining characteristics synonymous with the quality conduct of clinical trials. They discussed the need to shift the focus from individual investigators to the entire study team and identified value in mentorship, just-in-time training, and peer-to-peer networks to support site personnel in their specific roles. In addition, participants probed how it may be possible to develop and deliver more patient-centric training, foster a culture of learning, and drive the evolution of investigator qualification to include more adult learning approaches and a focus on how to apply knowledge—not just recall it. Attendees also identified the need for a harmonized system to better help sponsors identify suitable sites without mandating specific training.

As a next step in its Investigator Qualification work, CTTI will develop recommendations and resources to improve the quality of trial conduct through optimized approaches to qualifying investigators and their delegates.