Topics Included: Access to Clinical Trials, Ensuring Quality, Innovative Trials, Regulatory Submissions + Approvals
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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:
- Identifying Best Practices for Conducting Clinical Trials with FDA's COVID-19 Guidance
- Designing High-Quality, Streamlined COVID-19 Trials
- Solutions for Switching to Remote and Virtual Visits
- Engaging Racial and Ethnic Minority Patient Populations during the Pandemic
- Using Master Protocol Studies for Effective COVID-19 Treatments
- The State of U.S. COVID-19 Treatment Clinical Trials
- A daily searchable spreadsheet of the COVID-19-related studies posted on ClinicalTrials.gov is also available.
Resources
Regulatory Submissions + Approvals | Expert Meetings
The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies
CTTI hosted The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies Public Summit on Wed., Jan. 13. The summit, conducted as a webinar and moderated by Pamela Tenaerts, CTTI, included a welcome...
Regulatory Submissions + Approvals | Webinars
The State of U.S. COVID-19 Treatment Clinical Trials
CTTI Project: State of Clinical Trials Webinar Presenters: Robert Califf, Verily and Google Health Harlan Krumholz, Yale School of Medicine Leanne Madre, CTTI Deborah Zarin, Multi-Regional Clinical Trials Center of...
Regulatory Submissions + Approvals | Webinars
Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic
CTTI Project: Clinical Trials Issues Related to COVID-19 Webinar Presenters: David Borasky (WIRB-Copernicus Group) Sara Calvert (Clinical Trials Transformation Initiative) M. Khair ElZarrad (Food and Drug Administration/CDER) Cindy Geoghegan...
Ensuring Quality | Webinars
Designing High-Quality COVID-19 Treatment Trials
CTTI Project: Quality by Design Webinar Presenters: Pamela Tenaerts (Clinical Trials Transformation Initiative) Janet Woodcock (FDA, CDER) Ed Cox (Regeneron Pharmaceuticals, Inc.) Martin Landray (University of Oxford) John Marshall...
Regulatory Submissions + Approvals | Webinars
Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials
CTTI Project: Diversity Webinar Presenters: Pamela Tenaerts (Clinical Trials Transformation Initiative) Christina Brennan (Northwell Health) Richard Knight (American Association of Kidney Patients) Fabian Sandoval (Emerson Clinical Research Institute) Anand Shah...
Site Planning | Webinars
Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits
CTTI Project: Clinical Trials Issues Related to COVID-19 Webinar Presenters: Pamela Tenaerts (Clinical Trials Transformation Initiative) Jacqueline Corrigan-Curay (FDA, CDER) Laura Cooke (Amgen) Bray Patrick-Lake (Evidation Health, Inc.) Ramya Thota...
Site Planning | Case Studies
Accelerating eConsent Adoption During COVID-19
Accelerating eConsent Adoption During COVID-19
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 | CTTI News
CTTI Updates DCT Recommendations in Response to COVID-19
COVID-19 forced the clinical trials ecosystem to plan and conduct research in remote or virtual settings. In an effort to support this shift, CTTI is launching a project to update its Decentralized...
Regulatory Submissions + Approvals | CTTI News
Recording Now Available: The State of U.S. COVID-19 Treatment Clinical Trials Public Webinar
A recording for CTTI's public webinar, The State of U.S. COVID-19 Treatment Clinical Trials, held Apr. 15, is now available. In the webinar, moderated by CTTI Acting Executive Director Leanne Madre, CTTI presented...
Regulatory Submissions + Approvals | CTTI News
CTTI to Host Free Public Webinar on the State of U.S. COVID-19 Treatment Clinical Trials Featuring Robert Califf, Harlan Krumholz, and Deborah Zarin
CTTI will host a free public webinar on the state of U.S. COVID-19 treatment clinical trials on Thurs., Apr. 15 at noon EST. The U.S. has recently marked the one year anniversary...
Regulatory Submissions + Approvals | CTTI News
CTTI Announces New Playbook for Designing High-Quality, Diverse COVID-19 Trials
As the pandemic continues to endure worldwide, CTTI is leading the way in uncovering best practices for conducting COVID-19 trials. Following up on its first playbook focusing on conducting successful trials...
Regulatory Submissions + Approvals | CTTI News
Recording Now Available: The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies Public Summit
A recording for CTTI’s public summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, held Jan. 13, is now available. The summit, conducted as a webinar, opened with a welcome from Janet...
Regulatory Submissions + Approvals | CTTI News
CTTI to Host Jan. 13 Public Summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, Featuring Research & Healthcare Leaders
CTTI will host a public summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, on Wednesday, January 13. The summit, conducted as a webinar and moderated by CTTI Executive...
Regulatory Submissions + Approvals | CTTI News
Navigating the New Normal: CTTI Announces Playbook on Best Practices for Conducting Trials During COVID-19
As the world adapts to the COVID-19 pandemic, CTTI is leading the charge to help the clinical trials ecosystem evolve and move forward. Since March 2020, CTTI conducted a...
Regulatory Submissions + Approvals | CTTI News
Recording Now Available: Strategies for Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Trials
Given the recent statistics showing that COVID-19 disproportionately affects racial and ethnic minority communities, the recruitment and enrollment of diverse populations are crucial. In a webinar from Thurs., June 18,...
Regulatory Submissions + Approvals | CTTI News
Webinar to Share Strategies for Including Ethnically Diverse Populations in COVID-19 Trials
COVID-19 disproportionately affects racial and ethnic minority communities, and clinical trial professionals are struggling to recruit the diverse participant demographic needed to find an effective COVID-19 treatment that can work...
Regulatory Submissions + Approvals | CTTI News
Share Your Experiences: Recognizing The Need for Diversity in COVID-19 Clinical Trials
COVID-19 is disproportionately impacting racial and ethnic minority communities across the United States. We are asking everyone involved in clinical trials right now – IRB professionals, investigators, sponsors, participants, and...
Regulatory Submissions + Approvals | CTTI News
Webinar Recording Available: Listen to Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits
A recording for CTTI’s May 20 webinar, “Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits” is now available. Earlier this month, CTTI surveyed stakeholders to identify...
Regulatory Submissions + Approvals | CTTI News
Now Available: Searchable, Real-Time COVID-19 Clinical Studies Spreadsheet
The urgent need to rapidly identify safe and effective medical therapies has led to a spike in clinical studies on COVID-19. To help the global scientific community address this need,...
Regulatory Submissions + Approvals | CTTI News
CTTI Webinar on Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits
The COVID-19 pandemic has caused many ongoing trials to switch to remote and virtual visits midstream, despite it being unchartered territory for many. On Clinical Trials Day, Wed., May 20,...
Regulatory Submissions + Approvals | CTTI News
Share Your Experiences on Switching to Remote Visits for Clinical Trials during COVID-19
Now, more than ever, there is urgency to adopt telehealth for clinical research. But where do we begin? Exchanging ideas is the first step. As a valuable member of the...
Regulatory Submissions + Approvals | CTTI News
Recording Now Available: Designing High-Quality COVID-19 Treatment Trials
Designing clinical trials during a pandemic presents significant challenges. However, it is possible to build trials that yield high-quality results without slowing down the process. In a webinar from Thurs.,...
Regulatory Submissions + Approvals | CTTI News
Advancing Clinical Trials in the Age of the COVID-19 Pandemic
The COVID-19 pandemic has turned our world upside down. Every aspect of our ways of life are experiencing unprecedented disruptions. For the clinical trials community, we are seeing steep declines...
Regulatory Submissions + Approvals | CTTI News
CTTI to Host Webinar on Designing High-Quality COVID-19 Treatment Trials
As the research community races to identify safe and effective COVID-19 therapies, researchers are in need of accelerating trial design without sacrificing quality. The Clinical Trials Transformation Initiative (CTTI) will...
Regulatory Submissions + Approvals | CTTI News
Webinar Recording Available: Listen to Best Practices on Conducting Clinical Trials during COVID-19
During March 23-27, CTTI collected experiences from stakeholders across the clinical trials ecosystem – including insights on safety considerations, remote study visits, remote consent, consulting with IRBs, and more –...
Regulatory Submissions + Approvals | CTTI News
Webinar on Best Practices on Conducting Clinical Trials during COVID-19
This week, stakeholders from across the clinical trials ecosystem submitted experiences and insights related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19...
Regulatory Submissions + Approvals | CTTI News
Share Your Experiences Related to the New FDA Guidance on COVID-19
CTTI Will Collect, Share Findings & Best Practices at a March 31 Webinar Last week, the FDA issued new guidance on the conduct of clinical trials of medical products during the current...