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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.

 

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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)

Participant Summary: Site Investigator Perceptions of Mobile Clinical Trials – Summary of Interview Findings

Posted on by Hannah Faulkner

Participant Summary: Site Investigator Perceptions of Mobile Clinical Trials – Summary of Interview Findings

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.