Regulatory Submissions + Approvals Archives - Page 5 of 14

CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials

Posted on September 8, 2021March 5, 2025 by Hannah Faulkner

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap, CTTI held an “Obtaining Novel Endpoint Reliability & Acceptance” Expert Meeting on July 27-28 to inform its new recommendations and resources for driving novel endpoint acceptance.

Attendees discussed challenges and potential solutions to advancing the practical use of novel, digitally derived endpoints in clinical trials. They also uncovered and agreed on some important common themes:

The Time is Now. Digitally derived endpoints have the ability to capture information that is more reflective of how patients feel and function in their day-to-day lives – but many factors hinder their acceptance. Collaborative partnerships and solutions that increase the understanding and use of DHT-derived endpoints are needed to make this happen.
Fit-for-Purpose is a Must. DHT-derived endpoints need to be based on the specific context of use and validly measure a concept of interest in a way that is accurate, interpretable, and not misleading.
“Meaningful” in More than One Way. To develop a DHT-derived endpoint, have the community – including patients and clinicians – discuss what constitutes “meaningful” change. A meaningful measure should show treatment benefit as well as clinical benefit.
Engage Early and Often. Engage patients, investigative site personnel, and the FDA early and often when planning; involve biostatisticians and data scientists, as appropriate, in decisions regarding protocol design, data collection, analysis, and interpretation
Validate, Validate, Validate. It’s important to remember that validating a device is a separate, yet parallel, process from validating the clinical measure. It is also especially important to demonstrate analytical validation of DHT algorithms within the specific patient populations.

This meeting and its findings, part of CTTI’s Novel Endpoint Acceptance project, will help expand CTTI’s 2017 Novel Endpoint work, which produced a set of recommendations, flowchart, detailed steps, and many other resources for developing novel endpoints.

For a preview of CTTI’s expanded set of novel endpoints recommendations and resources, register to attend its Oct. 5 “Next Steps for Obtaining Novel Endpoint Reliability & Acceptance” webinar.

Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements

Topics Included: Data Collecting and Reporting, Regulatory Submissions + Approvals

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Timely, accurate, and complete registration and reporting of summary results for applicable clinical trials on ClinicalTrials.gov are crucial for providing patients, providers, researchers, and the public with access to information about clinical trials and their outcomes. Despite regulatory requirements and the importance of transparency in increasing knowledge of potential new treatments, multiple publications have reported gaps in clinical trial registration and results submission to the data bank.

To address this issue, CTTI collaborated with the U.S. Food and Drug Administration (FDA) on a project to understand barriers to timely, accurate, and complete registration and reporting of summary results for applicable clinical trials on ClinicalTrials.gov. The project involved in-depth stakeholder interviews and a survey to identify key challenges and explore potential solutions.

CTTI assessed the relevant themes and condensed the findings into a report containing strategies and recommendations for improving registration and reporting of summary results for applicable clinical trials. These strategies include proactive approaches to comply with regulatory requirements, keeping principal investigators and study teams informed, and providing education and guidance on meeting requirements. You can read the full report for a complete list of strategies.

Additionally, CTTI is developing a list of resources to assist with registering applicable clinical trials and reporting results on ClinicalTrials.gov.

What is the issue?

What CTTI project has been initiated to address this issue?

What are the objectives of this project?

As part of this work, CTTI conducted in-depth interviews and surveys to collect data.

In-depth interview objectives:

Describe organizational processes and policies on ClinicalTrials.gov registration and reporting of results information
Identify challenges that affect registration of applicable clinical trials and reporting of results information on ClinicalTrials.gov and proposed solutions

Survey objective:

Describe the prevalence of ClinicalTrials.gov processes, challenges, and solutions

Strategy and Best Practices Report:

Describe best practices that support the timely, accurate, and complete registration of applicable clinical trials and submission of clinical trial results information on ClinicalTrials.gov – ACTs
Ensure ClinicalTrials.gov includes timely and complete information about applicable clinical trials for those seeking information about clinical trials.

What research was done to collect data for the report?

CTTI interviewed 25 individuals representing 26 unique organizations to identify the range of barriers experienced by a variety of stakeholders, the root causes of these barriers, and potential solutions. CTTI used these initial findings to develop a survey to identify and quantify the most salient barriers to timely, accurate, and complete registration and reporting on ClinicalTrials.gov of applicable clinical trials. After surveying 92 individuals who represented 84 unique organizations, CTTI condensed the findings into a report containing strategies for improving registration and reporting of applicable clinical trials.

What were some of the challenges reported when registering and reporting results information for applicable clinical trials on ClinicalTrials.gov?

When describing challenges with registering and reporting 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 trials that must be registered,
- when they should be registered, and
- which trial results information must be submitted and when.

Administrative groups also reported challenges relating to non-responsive PIs and study teams, which hinder both timely registration and reporting of results of applicable clinical trials.

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.

What are the strategies created 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 in journals
- 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.

What is the anticipated impact of CTTI’s work on this topic?

Project Team Members

Role	Name	Affiliation
Assistant Social Scientist	Teresa Swezey	Clinical Trials Transformation Initiative
Communications Manager	Laura Shannon*	Clinical Trials Transformation Initiative
Lead Social Scientist	Amy Corneli	Clinical Trials Transformation Initiative
Project Manager	Sara Calvert	Clinical Trials Transformation Initiative
Project Manager	Kelly Franzetti	Clinical Trials Transformation Initiative
Team Member	Jodi Black*	Food and Drug Administration
Team Member	Milagros Blazquez	Bristol Myers Squibb
Team Member	Sherry Bous	Food and Drug Administration
Team Member	Donell Carey
Team Member	Donna Cryer	Global Liver Institute
Team Member	Constance Cullity	Advarra
Team Member	Julia Eckstein*	Food and Drug Administration
Team Member	M. Khair ElZarrad	Food and Drug Administration
Team Member	Bridget Foltz*	Food and Drug Administration
Team Member	Elisa Golfinopoulos	National Institutes of Health
Team Member	Derek Griffing*	National Institutes of Health
Team Member	Jan Hewett	Food and Drug Administration
Team Member	Sandra Hodnick	Cleveland Clinic Coordinating Center for Clinical Research (C5Research)
Team Member	Miah Jung	Food and Drug Administration
Team Member	Laura Levit	ASCO
Team Member	David Markert	Food and Drug Administration
Team Member	Kristen Miller	Food and Drug Administration
Team Member	Mike Patrizii	Bristol Myers Squibb
Team Member	Margaret Rankovic	CITI Program
Team Member	Jocelyn Riley	Cleveland Clinic
Team Member	Navaneetha Santhanam*	Bristol Myers Squibb
Team Member	Susan Stein	Cleveland Clinic
Team Member	Kimberly Taylor	Food and Drug Administration
Team Member	Patrick Zhou	Food and Drug Administration

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.

Resources

Regulatory Submissions + Approvals | CTTI News

CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap,...

Regulatory Submissions + Approvals

Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements

Timely, accurate, and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov is an important part of providing patients, providers, researchers, and the public with...

Regulatory Submissions + Approvals

Original Digital Health Trials Projects

Throughout 2015-2019, CTTI worked in four key areas to identify and address the challenges of planning for and conducting FDA-regulated clinical trials that use digital health technologies

Regulatory Submissions + Approvals | Resources

Best Practices for Designing High-Quality, Diverse COVID-19 Trials

Collating insights from across the clinical trials ecosystem, the Clinical Trials Transformation Initiative (CTTI) identified eight best practices for designing and conducting COVID-19 treatment clinical trials.

Regulatory Submissions + Approvals | Resources

Best Practices for Conducting Trials during the COVID-19 Pandemic

This document details the findings from CTTI’s surveys on ongoing trials during COVID-19 and expands on points highlighted during those corresponding webinars.

Regulatory Submissions + Approvals | Recommendations

Digital Health Trials: Recommendations for Interacting with Regulators

Regulatory Submissions + Approvals

Clinical Trials Issues Related to COVID-19

The COVID-19 pandemic turned our world upside down. And, within the clinical trials community, nearly every aspect of research experienced unprecedented disruptions.

Regulatory Submissions + Approvals | CTTI News

New CTTI Project to Explore the Challenges Preventing Timely and Complete ClinicalTrials.gov Reporting

Regulatory Submissions + Approvals | Resources

Flowchart: Steps For Novel Endpoint Development

Regulatory Submissions + Approvals | Resources

Detailed Steps for Novel Endpoint Development with Suggested Approaches & Considerations

Refine Your Selection

Formats

Stage of Trial

Original Digital Health Trials Projects

Topics Included: Data Collecting and Reporting, Innovative Trials, Regulatory Submissions + Approvals

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Throughout 2015-2019, CTTI worked in four key areas to identify and address the challenges of planning for and conducting FDA-regulated clinical trials that use digital health technologies:

Novel Endpoints
Digital Health Technologies
Decentralized Clinical Trials
Engaging Patients and Sites

Through this Digital Health Trials program, numerous organizations and individuals collaborated to create a suite of solutions that helped drive the evolution of the clinical trials to keep pace with technological innovations. Since then, as the landscape progressed and in light of COVID-19, CTTI repackaged its Digital Health Trials work into a refreshed, more practical, and easy-to-use format.

Original or complete materials not included in the repackaged section are hosted here for reference.

Novel Endpoints

Digital Health Technologies

Decentralized Clinical Trials

Engaging Patients and Sites

Project Team Members

Role	Name	Affiliation	Project
Project Manager	Jennifer Goldsack	Clinical Trials Transformation Initiative	Novel Endpoints
EC Champion	John Alexander	Duke University	Novel Endpoints
Social Science Lead	Brian Perry	Clinical Trials Transformation Initiative	Novel Endpoints
Team Leader	Lauren Bataille	MJFF	Novel Endpoints
Team Leader	Robert DiCicco	GSK	Novel Endpoints
Team Leader	Cheryl Grandinetti	FDA/CDER	Novel Endpoints
Team Leader	William Herrington	University of Oxford	Novel Endpoints
Team Leader	Martin Landray	University of Oxford	Novel Endpoints
Team Leader	Kaveeta Vasisht	FDA/OC	Novel Endpoints
Team Member	Elektra Papadopoulos	FDA/CDER	Novel Endpoints
Team Member	Ashish Narayan	Feinstein	Novel Endpoints
Team Member	Nirav Sheth	MC10	Novel Endpoints
Team Member	Ken Skodacek	FDA/CDRH	Novel Endpoints
Team Member	Komathi Stem	MonARCH Bionetworks	Novel Endpoints
Team Member	Theresa Strong	FPWR	Novel Endpoints
Team Member	Marc Walton	Johnson & Johnson/Janssen	Novel Endpoints
Project Manager	Annemarie Forrest	Clinical Trials Transformation Initiative	Digital Health Technologies
Social Science Lead	Amy Corneli	Clinical Trials Transformation Initiative	Digital Health Technologies
EC Champion	John Hubbard	Bioclinica Inc	Digital Health Technologies
Team Member	Marisa Bolognese	The Life Raft Group	Digital Health Technologies
Team Member	Philip Coran	Medidata Solutions	Digital Health Technologies
Team Member	Christopher Dell	Pfizer, Inc.	Digital Health Technologies
Team Member	Ray Dorsey	University of Rochester	Digital Health Technologies
Team Member	Cheryl Grandinetti	FDA/CDER	Digital Health Technologies
Team Member	Kaveeta Vasisht	FDA/OC	Digital Health Technologies
Team Member	Adam Amdur	ASAA	Digital Health Technologies
Team Member	Jessie Bakker	Phillips Respironics	Digital Health Technologies
Team Member	Aiden Doherty	University of Oxford	Digital Health Technologies
Team Member	Jonathan Helfgott	Johns Hopkins University	Digital Health Technologies
Team Member	Matthew Kirchoff	NIH	Digital Health Technologies
Team Member	Phillip Kronstein	FDA/CDER	Digital Health Technologies
Team Member	Christopher Miller	AstraZeneca Pharmaceuticals LP	Digital Health Technologies
Team Member	Ashish Narayan	Mt Sinai Health System	Digital Health Technologies
Team Member	Dharmesh Patel	FDA/CDRH	Digital Health Technologies
Team Member	Barry Peterson	Phillips Respironics	Digital Health Technologies
Team Member	Ernesto Ramirez	Fitabase	Digital Health Technologies
Team Member	Drew Schiller	Validic	Digital Health Technologies
Team Member	Tom Switzer	Genentech-a member of the Roche Group	Digital Health Technologies
Recommendations Advisory Committee	Riaz Bandali	Syneos Health	Digital Health Technologies
Recommendations Advisory Committee	Sheila Brown	FDA/OC	Digital Health Technologies
Recommendations Advisory Committee	Yan Chow	Amgen Inc	Digital Health Technologies
Recommendations Advisory Committee	Harold Collard	University of California, San Francisco	Digital Health Technologies
Recommendations Advisory Committee	Alan Frederickson	IQVIA	Digital Health Technologies
Recommendations Advisory Committee	Daniel Grant	Novartis	Digital Health Technologies
Recommendations Advisory Committee	Matthew Heasley	GSK	Digital Health Technologies
Recommendations Advisory Committee	Cynthia Kleppinger	FDA/CDER	Digital Health Technologies
Recommendations Advisory Committee	Seleen Ong	Pfizer, Inc.	Digital Health Technologies
Recommendations Advisory Committee	Linda Ricci	FDA/CDRH	Digital Health Technologies
Recommendations Advisory Committee	Daniel Rose	PFF	Digital Health Technologies
Recommendations Advisory Committee	Michele Russell-Einhorn	Advarra	Digital Health Technologies
Recommendations Advisory Committee	David Schneider	Syneos Health	Digital Health Technologies
Recommendations Advisory Committee	William Wood	UNC NC TraCS	Digital Health Technologies
Recommendations Advisory Committee	Jeremy Wyatt	ActiGraph	Digital Health Technologies
Project Manager	Lindsay Kehoe	Clinical Trials Transformation Initiative	Decentralized Clinical Trials
Social Science Lead	Amy Corneli	Clinical Trials Transformation Initiative	Decentralized Clinical Trials
Team Leader	Linda Coleman	Yale University	Decentralized Clinical Trials
Team Leader	Gary Grabow	Genentech-a member of the Roche Group	Decentralized Clinical Trials
Team Leader	Jan Hewett	FDA/CDER	Decentralized Clinical Trials
Team Leader	Barak Richman	Duke University	Decentralized Clinical Trials
Team Member	David Babaian	Quorum Review IRB	Decentralized Clinical Trials
Team Member	Mark Borigini	FDA/CDER	Decentralized Clinical Trials
Team Member	Matthew Bryant	Amgen Inc	Decentralized Clinical Trials
Team Member	Paul Conway	American Association of Kidney Patients	Decentralized Clinical Trials
Team Member	Kristin Dolinski	PhRMA	Decentralized Clinical Trials
Team Member	Jeffry Florian	FDA/CDER	Decentralized Clinical Trials
Team Member	Amy Hummel	Yale University	Decentralized Clinical Trials
Team Member	Gracie Lieberman	Genentech-a member of the Roche Group	Decentralized Clinical Trials
Team Member	Kristen Miller	FDA/CDER	Decentralized Clinical Trials
Team Member	Laura Podolsky	Science37	Decentralized Clinical Trials
Team Member	Vaishali Popat	FDA/CDER	Decentralized Clinical Trials
Team Member	Penny Randall	IQVIA	Decentralized Clinical Trials
Team Member	Ken Skodacek	FDA/CDRH	Decentralized Clinical Trials
Team Member	Marissa Stroo	Duke University	Decentralized Clinical Trials
Project Manager	Zachary Hallinan	Clinical Trials Transformation Initiative	Engaging Patients and Sites
Social Science Lead	Amy Corneli	Clinical Trials Transformation Initiative	Engaging Patients and Sites
EC Champion	Virginia Nido	Genentech-a member of the Roche Group	Engaging Patients and Sites
Team Leader	Cynthia Geoghegan	Individual Patient/Caregiver	Engaging Patients and Sites
Team Leader	Steve Morin	FDA/OC	Engaging Patients and Sites
Team Leader	Virginia Nido	Individual Patient/Caregiver	Engaging Patients and Sites
Team Leader	William Wood	UNC NC TraCS	Engaging Patients and Sites
Team Member	Maria Ali	The George Institute	Engaging Patients and Sites
Team Member	David Borasky	WCG	Engaging Patients and Sites
Team Member	Angie Botto-van Bemden	Individual Consultant	Engaging Patients and Sites
Team Member	Sue Dubman	Individual Patient/Caregiver	Engaging Patients and Sites
Team Member	Les Jordan	Target Health, LLC	Engaging Patients and Sites
Team Member	Hassan Kadhim	Boehringer Ingelheim	Engaging Patients and Sites
Team Member	Amanda Niskar	Individual Patient/Caregiver	Engaging Patients and Sites
Team Member	Paul O'Donohoe	Medidata Solutions	Engaging Patients and Sites
Team Member	Petros Okubagzi	MedStar Health	Engaging Patients and Sites
Team Member	Ido Paz-Priel	Genentech-a member of the Roche Group	Engaging Patients and Sites
Team Member	Ken Skodacek	FDA/CDRH	Engaging Patients and Sites
Team Member	Junyang Wang	FDA/CDER	Engaging Patients and Sites
Recommendations Advisory Committee	Matthew Bryant	Amgen Inc	Engaging Patients and Sites
Recommendations Advisory Committee	Anthony Costello	Medidata Solutions	Engaging Patients and Sites
Recommendations Advisory Committee	Karen Erickson	Alpha-1 Foundation	Engaging Patients and Sites
Recommendations Advisory Committee	Elisha French	Genentech-a member of the Roche Group	Engaging Patients and Sites
Recommendations Advisory Committee	John Hixson	VA	Engaging Patients and Sites
Recommendations Advisory Committee	Daniel Karlin	Pfizer, Inc.	Engaging Patients and Sites
Recommendations Advisory Committee	Megan Oakes	Duke University	Engaging Patients and Sites
Recommendations Advisory Committee	Bola Oyegunwa	IQVIA	Engaging Patients and Sites
Recommendations Advisory Committee	Penny Randall	IQVIA	Engaging Patients and Sites
Recommendations Advisory Committee	Michele Russell-Einhorn	Advarra	Engaging Patients and Sites
Recommendations Advisory Committee	Nirmish Shah	Duke University	Engaging Patients and Sites
Recommendations Advisory Committee	Angela Walker	Lilly	Engaging Patients and Sites
Recommendations Advisory Committee	Rob Wilson	ActiGraph	Engaging Patients and Sites
Project Manager	Lindsay Kehoe	Clinical Trials Transformation Initiative	Feasibility Studies
Team Member	Jessie Bakker	Philips Respironics	Feasibility Studies
Team Member	Michael Clarke	Queen's	Feasibility Studies
Team Member	Andy Coravos	Elektra Labs	Feasibility Studies
Team Member	Cynthia Geoghegan	Individual Patient/Caregiver	Feasibility Studies
Team Member	Alan Godfrey	Northumbria University	Feasibility Studies
Team Member	Jennifer Goldsack	DiMe	Feasibility Studies
Team Member	Matthew Heasley	GSK	Feasibility Studies
Team Member	Christine Manta	Duke University	Feasibility Studies
Team Member	Caroline Marra	Harvard University	Feasibility Studies
Team Member	Ernesto Ramirez	Evidation Health	Feasibility Studies
Team Member	Nirav Sheth	MicroMedicine	Feasibility Studies
Team Member	William Wood	UNC NC TraCS	Feasibility Studies

Organization affiliations are listed as active affiliations during the project.

*Indicates former project manager, team leader, or team member.

Resources

Regulatory Submissions + Approvals | CTTI News

CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap,...

Regulatory Submissions + Approvals

Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements

Regulatory Submissions + Approvals

Original Digital Health Trials Projects

Throughout 2015-2019, CTTI worked in four key areas to identify and address the challenges of planning for and conducting FDA-regulated clinical trials that use digital health technologies

Regulatory Submissions + Approvals | Resources

Best Practices for Designing High-Quality, Diverse COVID-19 Trials

Regulatory Submissions + Approvals | Resources

Best Practices for Conducting Trials during the COVID-19 Pandemic

This document details the findings from CTTI’s surveys on ongoing trials during COVID-19 and expands on points highlighted during those corresponding webinars.

Regulatory Submissions + Approvals | Recommendations

Digital Health Trials: Recommendations for Interacting with Regulators

Regulatory Submissions + Approvals

Clinical Trials Issues Related to COVID-19

The COVID-19 pandemic turned our world upside down. And, within the clinical trials community, nearly every aspect of research experienced unprecedented disruptions.

Regulatory Submissions + Approvals | CTTI News

New CTTI Project to Explore the Challenges Preventing Timely and Complete ClinicalTrials.gov Reporting

Regulatory Submissions + Approvals | Resources

Flowchart: Steps For Novel Endpoint Development

Regulatory Submissions + Approvals | Resources

Detailed Steps for Novel Endpoint Development with Suggested Approaches & Considerations

Refine Your Selection

Formats

Stage of Trial

Best Practices for Designing High-Quality, Diverse COVID-19 Trials

Posted on July 9, 2021February 21, 2025 by Hannah Faulkner

Best Practices for Designing High-Quality, Diverse COVID-19 Trials

Best Practices for Conducting Trials during the COVID-19 Pandemic

Posted on July 9, 2021February 21, 2025 by Hannah Faulkner

Best Practices for Conducting Trials during the COVID-19 Pandemic

Digital Health Trials: Recommendations for Interacting with Regulators

Posted on July 8, 2021February 5, 2025 by Hannah Faulkner

Digital Health Trials: Recommendations for Interacting with Regulators

Clinical Trials Issues Related to COVID-19

Topics Included: Access to Clinical Trials, Ensuring Quality, Innovative Trials, Regulatory Submissions + Approvals

SHARE TO:

Overview

The COVID-19 pandemic caused unprecedented disruptions to nearly every aspect of clinical research.

To help, CTTI led several efforts -- including conducting surveys, holding webinars, and developing resources -- with the goal of helping the clinical trials ecosystem adapt and move forward during the pandemic, including:

Two playbooks of best practices: "Best Practices for Conducting Trials During the COVID-19 Pandemic" and "Best Practices for Designing High-Quality, Diverse COVID-19 Trials".
Recordings of six CTTI COVID-19 webinars are available:
A daily searchable spreadsheet of the COVID-19-related studies posted on ClinicalTrials.gov is also available.

Resources

Regulatory Submissions + Approvals | CTTI News

CTTI Holds Meeting to Advance Novel, Digitally Derived Endpoints in Clinical Trials

Despite the increased use of digital health technologies (DHTs) in trials over the past several years, few examples of a digitally-derived primary endpoint exist today. Working to fill this gap,...

Regulatory Submissions + Approvals

Challenges Meeting U.S. ClinicalTrials.gov Reporting Requirements

Regulatory Submissions + Approvals

Original Digital Health Trials Projects

Throughout 2015-2019, CTTI worked in four key areas to identify and address the challenges of planning for and conducting FDA-regulated clinical trials that use digital health technologies

Regulatory Submissions + Approvals | Resources

Best Practices for Designing High-Quality, Diverse COVID-19 Trials

Regulatory Submissions + Approvals | Resources

Best Practices for Conducting Trials during the COVID-19 Pandemic

This document details the findings from CTTI’s surveys on ongoing trials during COVID-19 and expands on points highlighted during those corresponding webinars.

Regulatory Submissions + Approvals | Recommendations

Digital Health Trials: Recommendations for Interacting with Regulators

Regulatory Submissions + Approvals

Clinical Trials Issues Related to COVID-19

The COVID-19 pandemic turned our world upside down. And, within the clinical trials community, nearly every aspect of research experienced unprecedented disruptions.

Regulatory Submissions + Approvals | CTTI News

New CTTI Project to Explore the Challenges Preventing Timely and Complete ClinicalTrials.gov Reporting

Regulatory Submissions + Approvals | Resources

Flowchart: Steps For Novel Endpoint Development

Regulatory Submissions + Approvals | Resources

Detailed Steps for Novel Endpoint Development with Suggested Approaches & Considerations

Refine Your Selection

Formats

Stage of Trial

New CTTI Project to Explore the Challenges Preventing Timely and Complete ClinicalTrials.gov Reporting

Posted on June 14, 2021March 5, 2025 by Hannah Faulkner

Timely and complete registration and results reporting of clinical trial information is an important part of keeping patients, providers, researchers, and the public informed about clinical trials. The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that the responsible party for an applicable clinical trial register and submit results information for the trial to the ClinicalTrials.gov databank to promote transparency and accountability, in an effort to limit duplicity and encourage others to build on results. Despite the importance of this goal, public reporting has suggested that not all clinical trials are registered in a timely manner or have incomplete results.

To address this problem, CTTI is launching a new project to identify the challenges that lead to late registration and incomplete or missing results information for applicable clinical trials. The project will use in-depth stakeholder interviews and surveys to identify and explore the key challenges to timely submission of clinical trial information and identify potential solutions. The project will explore factors other than those related to the ClinicalTrials.gov platform and is intended to be complementary to the National Library of Medicine’s ClinicalTrials.gov Modernization initiative.

CTTI will use this data to develop informed best practices for responsible parties and other stakeholders. The findings from this project may also provide potential ways to support responsible parties in meeting the registration and results reporting requirements.