Quality
ICH Public Web Conference will Provide an Update on the Progress to Revise the Important and Impactful Good Clinical Practice Guideline
The International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) Expert Working Group (EWG) is organizing a public web conference to provide an update on the progress to revise this important and impactful guideline. The EWG is holding two similar web conferences, convened by CTTI, on Tuesday, May 18 from 8-11 a.m. EDT (2-5 p.m. CEST, 9 p.m. – 12 a.m. JST) and Wednesday, May 19 from 6-9 p.m. JST (5-8 a.m. EDT, 11 a.m. – 2 p.m. CEST) to reach a broad global audience across time zones. Per the conference agenda, the same topics will be presented each day with speakers from different regions to represent the global effort. All information and presentations will be provided in English.
To register and receive a link to the meeting, please select the date that you plan to attend. Individuals can attend both days, but it is not necessary. Please choose the time that works best for you:
- Day 1 Registration: Tuesday, May 18 from 8-11 a.m. EDT (2-5 p.m. CEST, 9 p.m. – 12 a.m. JST)
- Day 2 Registration: Wednesday, May 19 from 6-9 p.m. JST (5-8 a.m. EDT, 11 a.m. – 2 p.m. CEST)
When registering, please provide contact information as requested. Note that registration information must be submitted in English.
In this web conference, members of the ICH E6 EWG will discuss the work-in-progress to develop principles and annexes for ICH E6 GCP (third revision or E6(R3)) that are intended to be responsive across clinical trial types and settings and to remain relevant as technology and methodologies advance. The draft, work-in-progress principles that were made public by the ICH on April 19, 2021, are designed to be flexible and applicable to a broad range of clinical trials. View the principles on the ICH website. The EWG is not taking public comments on the principles at this stage. However, once the ICH E6 guideline achieves step 3 of the ICH guideline development process, the EWG will invite and consider public input.
The EWG will also discuss its plans and approaches to update the guideline in general and its engagement efforts with a variety of stakeholders that greatly enriched the discussions of the EWG. Recorded presentations of the public web conferences will also be posted on CTTI’s website following the conclusion of the live sessions.
Register today!
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 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 treatment studies. The presentation included 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 – 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 – discussed how the findings from the analysis can be applied to improvements needed across the clinical trials enterprise.
View the full slide deck for the public webinar to learn more from each presenter.
For additional information on CTTI’s COVID-19 work, please visit this web page.
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.