CTTI Project: State of Clinical Trials
CTTI Project: State of Clinical Trials
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.
During this webinar, 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, examined the current state of the clinical trials enterprise. Specifically, he addressed 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.
Clinical trials are critical components of the evidence generating system in research. Launched in 2021, CTTI’s Transforming Trials 2030 vision outlines five pillars for how clinical trials should be performed by 2030. This vision establishes that clinical trials need to be patient centered and easily accessible, fully integrated into health processes, designed with a quality approach, maximally leveraging all available data, and improving population health. Currently, the TT2030 vision lacks metrics to demonstrate progress towards the vision’s five central goals. The Measuring Trials Transformation (MTT) Project will develop a common framework to evaluate and assess the progress made towards achieving the five main goals of the TT2030 vision, a framework that can be used to share accountability across the clinical trials enterprise.
After launching the TT2030 vision, CTTI conducted concept elicitation interviews to develop key concepts metrics should address within each pillar. In 2022 and early 2023, CTTI conducted surveys of experts to assess the value of individual metrics for assessing progress towards the vision.
To deploy a set of relevant metrics, CTTI will utilize a variety of iterative strategies, including interviews with key stakeholders on their experiences with each pillar and ideas for related metrics, expert surveys on draft measures for each pillar, and an online public forum on the measurement framework. The selected metrics will be further refined by integrating public comment, expert input, and project team feedback and discussions. CTTI will perform a case study using the framework of metrics to measure progress towards the TT2030 vision by collecting and reporting an initial set of metrics using recent clinical trials.
CTTI understands that some goals of the TT2030 vision will be achieved sooner than others, and so the framework created by the MTT Project will establish key milestones to assess progress made by the program over time. CTTI will use this vision to guide their priorities, and they will encourage others to do the same, facilitating accountability across the entire clinical trials industry.
The Metrics Framework is currently open for public comment until mid-October 2023. Please view the dashboard and provide your suggestions and feedback here.
CTTI’s Transforming Trials 2030 vision outlines five key pillars for how clinical trials should be performed by 2030. This vision establishes that clinical trials, as critical parts of the evidence generating system, need to be patient centered & easily accessible, fully integrated into health processes, designed with a quality approach, maximally leveraging all available data, and improving population health. In order to gauge progress, the Measuring Trials Transformation project seeks to select measures that matter for assessing progress towards 2030. The project aims establish key milestones aligned to evidence generation to monitor, evaluate, and assess progress overtime.
Topics Included: Clinical Trials Landscape
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One of the initial steps to improving clinical trials is to document the current state of clinical trials in order to track changes over time. Researchers can use CTTI’s Aggregate Analysis of ClinicalTrial.gov (AACT) database to easily access and analyze data from the ClinicalTrials.gov registry to evaluate studies and characterize the current state of clinical trials.
As an example of the power of the database, CTTI created the AACT COVID-19 Trials Spreadsheet, a searchable spreadsheet of COVID-19-related studies posted on ClinicalTrials.gov.
CTTI has issued a number of key publications – including, "Characteristics of Clinical Trials Registered in ClinicalTrials.gov," "The Database for AACT and Subsequent Regrouping by Clinical Specialty," and "Compliance with Results Reporting at ClinicalTrials.gov" (plus dataset file here) – to document the state of clinical trials over time. Most recently, it delivered an update via The State of U.S. COVID-19 Treatment Clinical Trials webinar.
CTTI has launched an upgraded version of its Aggregate Analysis of ClinicalTrials.gov (AACT) database, which provides an analyzable dataset of all study information (including results) contained in ClinicalTrials.gov. These data can be used to characterize the clinical trials landscape and evaluate trends over time. CTTI gathered user feedback to design enhancements to the tool that would improve the timeliness of data, increase functionality, and make it accessible to a broader group of users.
For years, AACT has been used to uncover insights about the state of clinical trials. The datasets have been downloaded over 17,000 times and resulted in more than 20 publications. With these improvements, AACT will continue to be a valuable resource for assessing the clinical trial enterprise. For example, with the new NIH policy and the Final Rule for FDAAA 801 in effect for clinical trial results reporting, there is an opportunity for more organizations to use this timely and easily accessible data to monitor their compliance.
Previously updated twice per year, the database now resides in the cloud and is refreshed nightly with data from ClinicalTrials.gov. Historical AACT datasets also remain available for comparison. Researchers can query the database directly or download it as a static dataset. The new version of AACT is based on open-source technologies and requires no proprietary software.
Learn more about CTTI’s State of Clinical Trials Project.
The latest version of the AACT Database is now available on the CTTI website, along with the supporting documents.
CTTI’s State of Clinical Trials Project updates the Aggregate Analysis of ClincalTrials.gov (AACT) database twice annually. AACT is a restructured and reformatted relational database developed using publicly available and downloadable data from ClinicalTrials.gov. Since its initial release, the AACT database has been used to answer many questions regarding the landscape of clinical trials.
This latest dataset reflects data downloaded from ClinicalTrials.gov on March 27, 2016. To assist users with the interpretation of the data, a comprehensive data dictionary and points to consider document are also available on the CTTI website. Previous versions of AACT are posted as well.
