Author: Hannah Faulkner

ICH Public Web Conference will Provide an Update on the Progress to Revise the Important and Impactful Good Clinical Practice Guideline

Posted on by Hannah Faulkner

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

Posted on by Hannah Faulkner

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

Posted on by Hannah Faulkner

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 Launches New Case Study Resource to Help Drive Better, More Efficient Clinical Trials

Posted on by Hannah Faulkner

Building better clinical trials would be easier if organizations shared the practices that helped them successfully overcome obstacles. CTTI’s new resource, Building Better Clinical Trials: A Case Study Exchange, provides users with easy access to participating organizations to request more information and/or share information with others (via email, LinkedIn, or share icons) for open, honest information exchanges that can improve collaboration and increase the efficiency of clinical trials.

The site features case studies from more than 30 organizations that have applied CTTI’s recommendations and tools to improve clinical trials. These experiences provide helpful information on organizational challenges, opportunities, actions taken, the impact, lessons learned, and advice for others.

One case study that features Horizon Therapeutics’ experience using CTTI’s Patient Group Engagement (PGE) recommendations demonstrates how having access to the right resource can improve many aspects of clinical trial conduction. Jeffrey W. Sherman, Horizon’s Executive Vice President, Chief Medical Officer states, “Having the right tools at the right time can make or break a clinical trial. The Building Better Clinical Trials Case Study Exchange will not only make it easier for stakeholders to locate recommendations, resources, and solutions, but it will help them understand how these tools were successfully implemented by other organizations so they can sidestep potential roadblocks and streamline their clinical trials.”

By making these collective best practices and innovative solutions widely available, CTTI’s case study resource provides a forum that facilitates the exchange of ideas to create a clinical trial ecosystem that is more agile and adaptable. As Sonja Cloosterman, Principal Consultant Personalized Healthcare and Medical Affairs at Orikami put it, “The Case Study Exchange not only helps people find practical, actionable resources, but it serves as a way to generate an open flow of information that fosters greater collaboration and has the power to generate a global exchange of ideas within the larger clinical trials landscape.”

The hope is that sharing these lessons and experiences will lead to the creation of more efficient, streamlined trials.

Want to be featured on Building Better Clinical Trials: A Case Study Exchange?

Currently, the site features over 30 case studies, but more are being added regularly. If you are part of an organization that has used one of CTTI’s recommendations or tools and would like to be featured on the site, we may be able to include your story.

By sharing your experience, you can showcase your organization’s success while providing helpful information that will benefit other organizations and facilitate collaboration and knowledge sharing across the research community.

Please reach out to Karisa Merrill today to learn more.