CTTI is pleased to welcome its newest members. CTTI actively engages all stakeholders equally to collaboratively improve the quality and efficiency of the clinical trials enterprise. These organizations bring diverse viewpoints to help CTTI develop solutions with real-world impact.

• Alpha-1 Foundation: nonprofit promoting research for Alpha-1 Antitrypsin Deficiency
• Amici Clinical Research: clinical research center in New Jersey associated with a family practice treating 15,000 active patients.
• Boehringer Ingelheim: global, research-driven pharmaceutical company.
• Cystic Fibrosis Foundation: nonprofit and world leader in the search for a cure for cystic fibrosis.
• inVentiv Health: global provider of healthcare & pharma consulting to biopharmaceutical clients.
• Novartis: global healthcare company that provides solutions to address the evolving needs of patients worldwide.

CTTI now has more than 80 member organizations and several individual patient/caregiver representatives. Learn more about our diverse membership.

 

Former FDA Commissioner Dr. Robert Califf Offers a Glimpse of the Future of Clinical Research

The U.S. clinical research enterprise is undergoing enormous changes. Find out how new technologies, research methods and regulations are converging to reshape national approaches for generating evidence to guide healthcare decisions.

In a webinar now available as a recording on the CTTI website, Dr. Robert Califf offers his insights on the ongoing transformation of clinical research in the era of “omics,” big data, and activated patients. Drawing on his experience as a clinician, researcher, and most recently, head of the FDA, Dr. Califf surveys the current landscape of clinical trials, which despite incremental improvements are beset by rapidly rising costs and still fall short in providing the kinds of high-quality evidence needed by clinicians, patients, and policymakers.

However, he also notes that recent advances in technology, research methods, and patient engagement, further accelerated by provisions in the 21st Century Cures Act and the Food and Drug Administration Safety and Innovation Act (FDASIA), can provide the key elements needed to enable a more effective and efficient learning health system. These include:

• Continuous engagement with patients as active participants throughout the entire research process
• Innovation in approaches that can accommodate enormous quantities of biological information while also leveraging newly accessible “real-world data” to complement more conventional research methods
• Development of networks that enable secure data sharing and bidirectional learning
• Adoption of common standards for data storage, transfer and curation
• Renewed focus on streamlining of processes for clinical trials that promote efficiency and remove barriers

CLICK HERE to view the presentation slides and additional info.

Dr. Robert Califf, former Commissioner of the US Food and Drug Administration (FDA) and the Fortin Professor of Cardiology at the Duke University School of Medicine, will examine the current state of the clinical trials enterprise during a CTTI hosted webinar on Tuesday, March 14, at 12:00 p.m. Eastern Time.

ADD TO CALENDAR

During this webinar, Dr. Califf will address recent developments that have major implications for the clinical research enterprise in the United States, including the opportunities enabled by growing access to digital sources of data, the increasing importance of patient-reported outcomes, and the power of patient engagement in reshaping approaches to clinical research. As the recent head of FDA, Dr. Califf was directly involved in cross-agency efforts to modernize the national system for conducting clinical research by articulating a large, flexible, and widely shared approach to evidence generation (known as “EvGen”) that could leverage rapidly expanding sources of digital health data to produce high-quality, actionable information for patients and healthcare providers.

A particularly important aspect of these “EvGen” efforts hinges on effectively engaging patients and their advocates as partners in research, particularly as digital technologies and patient-reported outcomes data present new potential for the rapid and seamless acquisition of health data that is truly representative of broad and diverse populations. Ultimately, it is hoped that this new national research infrastructure will enable more rapid, representative, affordable, and generalizable clinical trials that can provide the high-quality evidence to enable a true learning health system. Many of these activities draw upon insights that were developed through pioneering investigations sponsored by CTTI, whose efforts will continue to shape national approaches to the creation and implementation medical knowledge.

Dr. Califf, who served as an original co-chair of CTTI and was instrumental in its creation, is a prominent cardiologist and clinical researcher whose career as a physician, teacher, researcher, and regulator spans more than three decades. Dr. Califf has provided leadership for numerous high-impact clinical trials and has been at the forefront of innovation in clinical research methods.

WEBINAR DETAILS:

This webinar is free and open to the public.
Meeting URL: https://dukemed.webex.com/dukemed/j.php?MTID=m62b866ad632870635fb7c4e690499fef
Meeting number (access code): 732 023 344
Meeting password: viewpoint

UPDATE: A RECORDING OF THIS WEBINAR IS NOW AVAILABLE ONLINE.

ACTIONS SPEAK LOUDER THAN WORDS—SEE HOW CTTI IS MAKING A DIFFERENCE IN OUR RECENTLY RELEASED 2016 ANNUAL REPORT.

In 2016, we updated our mission statement to reflect an emphasis on driving the adoption of our recommendations into practice, and this shift was felt across our project portfolio.  For example,

• We released tools to help organizations integrate recruitment planning throughout all stages of a clinical trial and to better engage all stakeholders, which can lead to increased clinical trial enrollment.
• We delivered actionable recommendations for how to organize and conduct data monitoring committees to enhance the quality of clinical trial oversight.
• To support organizations in adopting our early enrollment strategy for more feasible HABP/VABP trials, we enrolled >5,750 patients in a study to provide real-world evidence for this approach.

In addition to these achievements, CTTI’s work is being implemented at a variety of organizations across the clinical trial spectrum. In this annual report, learn how the Cystic Fibrosis Foundation, Eli Lilly, FasterCures, and UCB Pharmaceuticals are using CTTI’s work today.

We are proud of all that was accomplished last year with the active engagement of our members and others. Through collaborative efforts, we will continue to bring about more efficient and quality-driven clinical trials that deliver valuable evidence to improve the lives of patients.

“In this report, we detail CTTI’s 2016 successes confronting leading challenges, such as participant recruitment for clinical trials and a lagging pipeline for desperately needed new antibacterial therapies. In each priority area, we developed evidence-based, consensus-driven recommendations to fuel meaningful changes in medical product development, and we drove adoption of these approaches to make better clinical trials a reality.”

-Pamela Tenaerts, MD, MBA, Executive Director, CTTI

CTTI is pleased to welcome its newest members, Alnylam Pharmaceuticals and the American Society of Clinical Oncology (ASCO).

Alnylam Pharmaceuticals is a pharmaceutical company focusing on the development of new therapeutics that use the RNA interference process to silence disease-causing genes. Their representative joining CTTI’s Steering Committee is Pushkal Garg, Senior Vice President, Clinical Development.

ASCO is the leading professional organization for physicians and oncology professionals caring for people with cancer. Their representative joining CTTI’s Steering Committee is Patricia Hurley, Associate Director, Research and Analysis, Policy and Advocacy Department.

Alnylam and ASCO join over 80 other diverse member organizations that are collaborating with CTTI to develop solutions with real-world impact. CTTI actively engages all stakeholders equally to improve the quality and efficiency of the clinical trials enterprise. Learn more about our diverse membership.

 

*These numbers reflect organizations on CTTI’s Steering Committee. In addition, our membership includes 3 individual patient/caregiver representatives.

In furtherance of our quest to drive adoption of practices that will increase the quality and efficiency of clinical trials, CTTI has launched a new website that provides easy access to recommendations and tools that can lead to better clinical trials.

What’s new?

• CONTENT NOW ORGANIZED BY TOPIC: The new website packages CTTI’s robust portfolio of work into intuitive, easy-to-navigate topics, such as central IRBs and recruitment.. Within each topic, the new layout gives prominence to critical content, including latest news and most used resources.
• OPTIMIZED, RESPONSIVE LAYOUT: The updated design features a responsive layout, which will optimize the visitor’s experience across devices and browsers.
• NEW URLs: New URLs will exist for the project and program pages, but don’t worry! We are setting up re-directs to make this transition as seamless as possible for you. This means that the old URLs will still work, but cleaner, more direct URLs will exist for content related to projects and programs.

If you are having issues locating content, you can:

• Try the search bar, located in the top right corner of our site
• Email our communications specialist, Noel Benedetti (noel.benedetti@duke.edu)

We welcome your feedback on the new site. If you have any suggestions for improvement, please send your thoughts to Noel. Thank you for your patience and input as we continue to improve your access to resources that help drive change in the clinical trials enterprise.

On May 17 – 20, 2015, the Society for Clinical Trials will host its 36th Annual Meeting in Arlington, VA. An international community of professionals from a variety of disciplines will gather for three days of workshops, presentations, and discussions on the design, conduct, and analysis of clinical trials. CTTI will participate in several events throughout this conference and we look forward to discussing a number of practices that will increase the quality and efficiency of clinical trials.

 

Presentation: Making Trials Better: CTTI Recommendations for Developing Protocols and Identifying Safety Signals (Invited Session 8)
Date: May 18, 2015 from 12:45 – 2:15 PM
Presenters: Pamela Tenaerts (CTTI), Martin Landray (Oxford), Nancy Roach (Patient Representative), Janet Wittes (Chair of CTTI Biostatistics Workgroup)

 

Presentation: CTTI Recommendations for Developing Clinical Trials Pregnancy Testing Plans (Topic Contributed Session 3)
Date: May 18, 2015 from 2:45 – 3:45 PM
Presenters: Sara Calvert, Organizer (CTTI), Evan Myers (Duke University), Claire Jurkowski (Bristol Myers Squibb), Melissa Tassinari (FDA/CDER)

 

Presentation: Improving the Clinical Trial Process through Effective Engagement – Perspectives from the NIH, CTTI, PCORI, and Patient Advocacy Foundations (Invited Session 12)
Date: May 18, 2015 from 4:00 – 5:30 PM
Presenters: Megan O’Boyle (Phelan McDermid Syndrome Foundation), Bray Patrick-Lake (CTTI), Jamie Roberts (CTTI), Jaya Bea Smalley (PCORI), Veronica Todaro (Parkinson’s Disease Foundation)

 

Presentation: The Clinical Trials Transformation Initiative Data Monitoring Committee Project: Findings And Next Steps (Invited Session 27)
Date: May 20, 2015 from 9:15 – 10:45 AM
Presenters: Annemarie Forrest, Organizer (CTTI), Patrick Archdeacon (FDA), Ray Bain (Merck), Karim Calis (FDA)

 

Presentation: Trial Forge: A Systematic Approach to Making Trials More Efficient (Session 30)
Date: May 20, 2015 from 11:00 AM – 12:30 PM
Presenters: Peter Bower (University of Manchester), Marion Campbell (University of Aberdeen), Kerry Hood (University of Cardiff), Jamie Roberts (CTTI), Mary Foulkes, Discussant (George Washington University), Shaun Treweek, Organizer (University of Aberdeen)