Formats
CTTI to Launch New Recommendations for Embedding Clinical Trials into Clinical Practice
CTTI will host a free public webinar on Thurs., Dec. 15 to unveil new recommendations for embedding clinical trials into clinical practice.
The webinar will include a welcome from Sally Okun, CTTI Executive Director; a keynote
presentation from a special guest with the FDA; a project overview from Matthew Roe,
AstraZeneca; and a panel discussion moderated by Lindsay Kehoe, CTTI Senior Project
Manager. The panel discussion, which will focus on stakeholder perspectives related to the
integration of the new recommendations, includes: Sam Bozzette, National Institutes of Health;
Lara Jehi, Cleveland Clinic; Holly Robertson, Medidata; and Alandra Weaver, Crohn’s & Colitis
Foundation.
Embedding elements of clinical trials, such as randomization, administration of study drug, and
data acquisition, into routine care reduces duplication of trial and care activities and promotes the
development of a learning health care system. This will naturally lead to better decision-making,
treatment options, and outcomes for patients.
However, integrating interventional clinical trials into health care settings is challenging and
complex, and operational direction is needed. As part of the Trials in Clinical Practice project,
CTTI has conducted in-depth interviews with study designers and implementers, gathered case
examples, and is now ready to share the recommendations it’s created to facilitate the integration
of randomized, interventional trial elements into clinical care; including, but not limited to, trials of
drugs, devices, and biologics intended for regulatory review.
The free 60-minute webinar will begin at 12:00pm EST and registration is not required.
CTTI Conducting Survey on Registering and Reporting Clinical Trial Information on ClinicalTrials.gov
The ClinicalTrials.gov Reporting Challenges Project is conducting a survey following in-depth interviews that were conducted in late 2021. We invite individuals who provide oversight, register, and/or report trial results information on ClinicalTrials.gov to complete the survey. You may also forward this survey to others who you know register and/or report clinical trial information on ClinicalTrials.gov.
Additional information for potential survey participants is provided below.
What are you being invited to do?
CTTI is conducting a survey to learn more about organizations’ experiences with registering and reporting clinical trial information on ClinicalTrials.gov.
We invite individuals at organizations such as academic institutions, medical product companies, government agencies, and non-government organizations who provide oversight, register, and/or report trial results information on ClinicalTrials.gov to complete the survey.
The survey focuses on policies and approaches your organization implements to comply with ClinicalTrials.gov regulatory requirements, as well as the advantages and disadvantages of your approaches, challenges faced, and suggested strategies for addressing challenges.
How will CTTI use the information?
CTTI will outline useful practices for improving the reporting of timely, accurate, and complete registration and results information on ClinicalTrials.gov.
Your name and organization will not be included when CTTI reports the survey findings. CTTI will send the FDA an aggregated summary of survey findings to inform their approach to supporting more complete reporting of clinical trial information.
Interested in participating?
If you provide oversight, register, and/or report clinical trial information on ClinicalTrials.gov, please click on this link to take the survey.
You may also forward this survey to others who you know register and/or report clinical trial information on ClinicalTrials.gov.
Have questions?
For questions about this survey, please email CTTI Project Manager Kelly Franzetti.
CTTI Holds Meeting to Discuss Conducting Trials as Part of Clinical Practice
The Clinical Trials Transformation Initiative (CTTI) held a multi-stakeholder Expert Meeting on September 21 to discuss embedding aspects or elements of trials into clinical practice. The goal is to have care inform research and research inform care, therefore, CTTI created a set of recommendations to facilitate the integration of randomized, interventional trial elements into clinical care. Although trials and key initiatives are already paving the way, including the ACTIV-6 Study, the RECOVERY Trial, the Coalition for Advancing Clinical Trials at the Point of Care (ACT@POC), and the National Patient-centered Outcomes Research Network (PCORnet), challenges remain in driving change and measuring the impact of this change. At the Trials in Clinical Practice Expert Meeting, held in Washington, D.C., participants identified pain points of embedding trial elements, shared how CTTI recommendations can overcome those pain points, and brainstormed ways to measure implementation of the recommendations.
Dr. Janet Woodcock, Principal Deputy Commissioner of the U.S. Food and Drug Administration, reiterated the imperatives for conducting trials as part of clinical practice, indicating that we have inadequate evidence for care, lack of representativeness of most Americans and health care settings, and an underperforming emergency response mechanism for national health crises.
Meeting attendees identified some important themes:
- The ability to embed aspects of a trial (eligibility and patient identification, informed consent, randomization, intervention, trial data acquisition, and evidence integration) will depend on a variety of factors:
- Aligning trial design with clinical workflow to minimize provider and patient burden
- Ensuring site readiness with appropriately trained staff and technology resources
- Defining clear channels of accountability
- Raising awareness of the value of research and its subsequent impact on care.
- Technology and reusable networks can help overcome some of the barriers, as can changes in culture and policy and good partnerships with patient groups, health system leaders, and IT leaders.
- CTTI recommendations provide design and operational clarity to embed trial elements, but their adoption will require engagement with health care providers, technology support, and ways to measure progress.
Meeting attendees also discussed how to measure whether adoption of CTTI Trials in Clinical Practice recommendations is improving the quality and efficiency of trials.
Initial themes fell into two camps:
- Measures of progress in clinical trial quality
- Measures of progress towards a learning health care system.
To assess progress of clinical trial quality, measures might include:
- improved enrollment/retention rate
- whether trials have enrolled reflective and representative populations that align with those being cared for
- participant and health care provider satisfaction/experience with research.
To assess progress at the learning health system level, measures might include:
- whether embedded trials are producing impactful, reliable results that are integrated into clinical decision making
- the proportion of practices in the health care ecosystem that are involved in research
- changes in reimbursement policies
- involvement of medical journals that report on elements embedded into care.
CTTI Welcomes Four New Members to its Executive Committee
Today, CTTI welcomed four new members to its Executive Committee, which is responsible for making decisions about the overall direction and strategy for the organization. The new Executive Committee members, whose three-year term runs from 2022-2025, include:
- Barbara Bierer, The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard
- Michael Cuffe, HCA Healthcare
- Esther Krofah, FasterCures, of the Milken Institute
- Virginia Nido, Roche Genentech
“CTTI is honored to welcome this impressive group of leaders from across the clinical trials enterprise to our Executive Committee,” said Sally Okun, CTTI Executive Director. “From medicine to health care to public policy to pharma, these four new EC members will play an important role in helping CTTI achieve our goals to transform clinical trials by 2030.”
“The distinguished and diverse new Executive Committee members will bring a unique combination of expertise, talent and dedication to advance CTTI’s mission,” said CTTI Executive Committee Chair Mark McClellan. “We are looking forward to the valuable perspectives and shared commitment they each bring to our efforts to improve and transform clinical trials.”
The 14-member Executive Committee, chaired by McClellan, and co-chaired by Khair ElZarrad (FDA) and John Alexander (Duke University), includes distinguished U.S. and international thought leaders in government, academia, industry, and patient advocacy who are experienced at envisioning and facilitating improvements in health care and medical research systems. This group ensures that CTTI informs and facilitates meaningful improvements to the design and conduct of clinical trials.
The Executive Committee members whose terms continue are: Donna R. Cryer, Global Liver Institute; Pat Furlong, Parent Project Muscular Dystrophy; Patricia Hurley, American Society of Clinical Oncology; Theodore Lystig, BridgeBio; Robert Temple, FDA; Spiros Vamvakas, European Medicines Agency; and Bram Zuckerman, FDA.
CTTI also wishes to express sincere gratitude to its outgoing Executive Committee members for their 12 years of collective service from 2019-2022: Steven Galson, Amgen; Michael Kolodziej, ADVI Health; Rod MacKenzie, Pfizer; and Pierre Meulien, Innovative Health Initiative.
