COVID 19
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 of the official declaration of the COVID-19 pandemic by the World Health Organization. The pandemic thrust clinical research into the limelight like never before and – while daunting and challenging – the scientific community answered its collective call-to-duty with impressive vigor and determination. But our work continues and this anniversary provides an important opportunity for reflection, discussion and evaluation.
Many have pointed to a large number of initiated clinical trials as evidence of successful research in response to the global health crisis. However, the true measure of success should be in actionable and reliable research results that are available to inform clinical, policy and research decisions related to the diagnosis, treatment, and prevention of COVID-19 and its variants.
In this webinar, moderated by CTTI Acting Executive Director Leanne Madre, CTTI will present findings from an analysis of data downloaded from the database for the Aggregate Analysis of ClinicalTrials.gov (AACT) on the state of U.S. COVID-19 studies. The presentation will include an overview of the U.S. COVID-19 clinical trials landscape, the availability of results, and changes in the portfolio as time has progressed. The presenters, including Robert Califf, Verily and Google Health; Harlan Krumholz, Yale School of Medicine; and Deborah Zarin, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University, will discuss how the findings from the COVID-19 analysis can be applied to improvements needed across the clinical trials enterprise.
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 during the pandemic, CTTI is now releasing a second playbook with eight essential principles for high-quality, diverse COVID-19 trials.
These elements, fully outlined in the new COVID-19 playbook, recommend that stakeholders:
- Learn from the past and what’s being done now
- Make the time to design right, but move quickly
- Adequately power trials
- Randomize trials
- Maintain ethics
- Collaborate on study design
- Engage and enroll racial and ethnic minorities
- Use a core set of inclusion and exclusion criteria and endpoints
- Collaborate and coordinate
Beginning in April 2020, CTTI conducted an analysis of COVID-19 treatment trials in ClinicalTrials.gov, met with key stakeholders to discuss best practices for designing these types of trials, and launched a public survey on how to engage racial and ethnic minority patient populations in COVID-19 trials. CTTI communicated the resulting best practices during two CTTI-hosted webinars on designing high-quality COVID-19 treatment trials and engaging racial and ethnic minorities in COVID-19 trials.
These resources can help researchers adapt to the changing landscape and generate meaningful evidence despite the unprecedented challenges presented by the pandemic. Learn more about what CTTI is doing to address clinical trials issues related to COVID-19.
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 Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; and included three panel discussions focused on solutions related to scaling master protocols.
The first panel, Practical Solutions to Setting Up Master Protocol Sites, moderated by Pamela Tenaerts, CTTI, with panelists Derek Angus, REMAP-COVID; Laura Esserman, I-SPY-COVID; and Manizhe Payton, ACTIV-2, examined key challenges and potential solutions to starting up new sites including contracting, competing trials, staffing, and IRB submission.
The second panel, Increasing Participant Enrollment in Master Protocols, moderated by Esther Krofah, Faster Cures, with panelists Kousick Biswas, Veterans Health Administration; Dan Cooper, UC Irvine; and Martin Landray, RECOVERY Trial, examined the key challenges limiting participant enrollment including competition with other trials, burden on staff, and discussed potential solutions to overcome hurdles such as co-enrollment.
The final panel, Lessons for the Future, moderated by Mark McClellan, Duke-Margolis Center for Health Policy, with panelists Sam Brown, Intermountain Health System; Adrian Hernandez, PCORnet; and Saye Khoo, AGILE, discussed policy changes needed to improve future pandemic preparedness.
The public summit also addressed the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov, and findings from a pre-summit survey of those involved in COVID-19 treatment master protocols, specifically those involved in setting up new sites or recruiting participants at existing sites.
View the full slide deck for the public summit to learn more from each presenter.
For additional information on CTTI’s master protocols work, please refer to this web page.
This public summit is part of a collaborative effort with the Duke-Margolis Center for Health Policy at Duke University and FasterCures, of the Milken Institute.
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 Director Pamela Tenaerts, will include a welcome from Janet Woodcock, Operation Warp Speed; a call-to-action from Robert M. Califf, Verily and Google Health; remarks from Mark McClellan, Duke-Margolis Center for Health Policy; and a panel discussion moderated by Esther Krofah, FasterCures. The panel discussion will focus on solutions related to scaling master protocols, including:
- Overcoming barriers to starting up sites
- Increasing participants at existing sites
- Using the COVID experience to inform our preparedness for future pandemics
“As we’ve learned in the global pandemic, the faster we have reliable answers, the better,” said Tenaerts. “As we look to successfully accelerate progress for COVID-19 treatments, the need for collaborative trials that supply reliable insights has never been greater and in many cases, master protocol studies can provide the solution.”
This public summit will also address the status of COVID-19 clinical trials, including results from a recent CTTI analysis of data from ClinicalTrials.gov and other research, and examine the use of common platforms to optimize the design of master protocols for multiple therapies attempting to treat the same diseases or specific health problems.
The free public summit will be held from 10:30am until noon EST.
This public summit is part of a collaborative effort with the Duke-Margolis Center for Health Policy at Duke University and FasterCures, a Center of the Milken Institute.
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 series of initiatives to help the research community successfully navigate the challenges associated with adjusting trials that were underway when the pandemic hit. These initiatives and resulting best practices are captured in a new playbook, Best Practices for Conducting Trials During the COVID-19 Pandemic.
CTTI gathered experiences and learnings from across the clinical trials ecosystem via public surveys and discussions, and communicated these findings during two CTTI-hosted webinars. These efforts extrapolated best practices for conducting clinical trials with new FDA guidance on COVID-19, as well as solutions to help investigators shift to remote and virtual visits during the COVID-19 pandemic.
Through this initial work when the pandemic first hit, CTTI identified eight essential best practices on how to conduct clinical trials during the pandemic. These key points, fully outlined in the new COVID-19 playbook, recommend that stakeholders:
- Keep participants informed
- Perform outgoing risk-benefit assessment
- Communicate with IRBs and regulatory authorities
- Adjust new study starts and enrollment based on risk
- Pivot to remote study visits
- Switch to remote monitoring
- Be flexible
- Document everything with COVID-19 tags
The new document provides detailed information on how stakeholders can best integrate these important recommendations into their ongoing clinical trials while providing several additional resources to fully support these efforts. This comprehensive resource will help researchers adapt to the changing clinical trial landscape and continue to conduct successful studies during the pandemic.