Adoption of Decentralization: Are Our Perceptions Holding Us Back?
Data Collecting and Reporting
Recording Now Available: CTTI Unveils New Tool for Embedding Clinical Trials into Clinical Practice
A recording of CTTI’s Feb. 29 webinar unveiling a new tool that aids in assessing the feasibility of embedding clinical trial elements into clinical practice is now available.
The one-hour webinar included a welcome from CTTI Director of Projects Sara Calvert; a project overview from CTTI Senior Project Manager Lindsay Kehoe; a panel discussion focused on stakeholder perspectives related to the practical use of the tool; and a request for input on how to optimize the tool’s use.
Embedding elements of clinical trials, such as patient identification, informed consent, and data acquisition, into routine care reduces duplication of trial and care activities and promotes the development of a learning health care system. This can naturally lead to better decision-making, treatment options, and outcomes for patients.
This tool is a part of CTTI’s Embedding Trials in Clinical Practice work, which aims to enable health care settings to participate in embedded trials and assists sponsors with their design and conduct.
View the slide deck to learn more.
CTTI to Launch New Embedding Trials Feasibility Assessment Tool
CTTI will host a free public webinar on Thursday, Feb. 29 at 12:00 p.m. EST to unveil a new tool for assessing the feasibility of embedding clinical trial elements into clinical practice.
The webinar will include a welcome from Sara Calvert; a project overview from Lindsay Kehoe; a panel discussion that will focus on stakeholder perspectives related to the practical use of the tool; and an opportunity for you to help CTTI optimize its use.
Embedding elements of clinical trials, such as patient identification, informed consent, and
data acquisition, into routine care reduces duplication of trial and care activities and promotes the
development of a learning health care system. This can naturally lead to better decision-making,
treatment options, and outcomes for patients.
However, integrating interventional clinical trials into clinical practice is complex, and operational direction is needed. Supporting recently released recommendations, CTTI created a new tool that aims to aid sponsors involved in early planning and design of a clinical trial by providing insight into site readiness and feasibility of integrating trials into clinical practice.
CTTI and FDA Share Strategies for Improving Timely, Accurate, and Complete Registration and Reporting of Summary Results Information for Applicable Clinical Trials on ClinicalTrials.gov
Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov allows access to current research and evidence for all partners in the clinical trials enterprise, including patients, providers, sponsors and investigators, regulators, payers, and health system leaders. Despite the regulatory requirements for applicable clinical trials and the importance of fostering transparency while increasing knowledge of potential new treatments in development, multiple publications have reported gaps in clinical trial registration and results information submission to the data bank.
To address this issue, the Clinical Trials Transformation Initiative (CTTI) collaborated with the Food and Drug Administration (FDA) on a project to understand the barriers to timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov. The project involved in-depth interviews and a survey to identify the range of barriers and their salience by type of stakeholder, root causes influencing barriers, and potential solutions and helpful practices to implement moving forward. After the relevant themes were assessed, CTTI surveyed 92 individuals who represented 84 unique organizations and condensed this information into a report containing strategies and recommendations for improving registration and reporting.
Some of the strategies include:
- Use a centralized/dedicated approach to meeting ClinicalTrials.gov requirements
- Take a proactive, rather than reactive, approach to complying with ClinicalTrials.gov regulatory requirements
- Escalate to upper levels of leadership for PIs/study teams that are non-responsive to the administrative unit’s communication about compliance
- Inform PIs/study teams
- about the possibility of civil money penalties for non-compliance with ClinicalTrials.gov regulatory requirements;
- that submitting results information on ClinicalTrials.gov is separate from publishing results; and
- that, per ICMJE, reporting results information on ClinicalTrials.gov does not preclude publishing results in journals
- Provide education, resources, guidance, and support about meeting ClinicalTrials.gov requirements to PIs/study teams and other research personnel
See the full report for a complete list of strategies.
When describing challenges with registering and reporting summary results information from applicable clinical trials, respondents cited several major challenges:
- A lack of understanding on the part of the Principal Investigator (PI) and their study team regarding
- the type of trial that must be registered,
- which trial results must be submitted,
- and when they should be registered.
- Administrative groups also reported challenges relating to non-responsive PIs and study teams, which hinders both timely registering and reporting of results.
- For reporting, PIs and study teams responding to the survey also expressed concerns about waiting until all data are analyzed before reporting results information on ClinicalTrials.gov to prevent discrepancies between ClinicalTrials.gov data and published results.
For more information, see CTTI’s Project page: Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements.
CTTI Publication Investigates Challenges and Solutions Surrounding Digitally Derived Endpoint Acceptance
A new CTTI publication, published in Digital Biomarkers, investigates the challenges sponsors encounter when using digitally derived endpoints and offers potential solutions. Digital health technologies – including mobile apps, smart devices, sensors, and wearables – can capture robust data from participants’ daily lives. These digital tools allow researchers to collect data for novel endpoints that can provide a broader view of health and treatment effects using measures that matter to patients. Despite these benefits to clinical trial quality and efficiency, digitally derived endpoints are still underutilized as primary evidence in regulatory submissions.
To evaluate the barriers and challenges associated with digitally derived endpoints to support labeling claims, CTTI interviewed 20 sponsor representatives from 10 different organizations representing 11 individual clinical trials. During these interviews, conducted between November 2020 and March 2021, sponsor representatives were asked about their experiences related to digitally derived endpoints, their interactions with regulators, and the challenges they encountered. Based on these interviews, CTTI identified five key challenges to incorporating digitally derived endpoints in clinical trials:
- a lack of regulatory guidance specific to digitally derived endpoints;
- a qualification process for new clinical outcomes that is impractical for most industry sponsors;
- a lack of comparable clinical endpoints to validate novel digitally derived endpoints;
- a lack of validated DHTs and algorithms for a concept of interest; and
- a lack of operational support from technology vendors.
CTTI shared these interview findings with the U.S. Food & Drug Administration (FDA) and the European Medicines Agency (EMA) and during a multi-stakeholder expert meeting. Through these discussions, CTTI drafted and refined a set of recommendations and tools for developing novel digitally derived endpoints as part of the Digital Health Trials Hub. These resources provide a robust toolkit for sponsors, investigators, and operational partners navigating the regulatory landscape around digitally derived endpoints.