CTTI News

Recording of Public Web Conference Now Available: Listen to ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress

Posted on by Hannah Faulkner

Recordings for the International Council for Harmonisation’s public web conference, held May 18 & 19, “ICH E6 Guideline for Good Clinical Practice (GCP) – Update on Progress,” are now available.

The web conference, which consisted of identical meetings at different times over two days to accommodate a global audience, opened with welcoming remarks followed by a video session wherein ICH E6 Expert Working Group (EWG) members shared the ICH guideline development process and the approach to updating ICH E6(R3). The second session of the web conference focused on the vision and goals for the work to update the E6 guideline and lessons learned from public input and stakeholder feedback. In the final session of the web conference, members of the EWG presented the published draft, work-in-progress principles. Then, experts and advocates provided their vision and aspirations on the clinical trial enterprise in general.

View the full slide deck for day of the web conference to learn more from each presenter.

For additional information on updating the ICH E6, please refer to the following materials:

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.

CTTI Selects Three New Patient/Caregiver Representatives for Steering Committee

Posted on by Hannah Faulkner

CTTI is delighted to welcome three new patient/caregiver representatives, Jamil Rivers, Phil Green, and Nuru Noor, to our Steering Committee.

The new patient/caregiver representatives will play a key role alongside the existing CTTI members in CTTI activities to advance CTTI’s vision to Transform Trials 2030. Their voices and contributions will add valuable insight and create transformative practices that advance the future of clinical trials.

Each new representative brings a remarkable background and set of experiences they will use to communicate the current needs of patients and caregivers. Please find additional information about them below.

Welcome Jamil, Phil, and Nuru – we are excited to have you on board!

Jamil Rivers

Jamil Rivers was diagnosed at age 39 with metastatic breast cancer. As someone who holds a Bachelor of Science degree from Rutgers University, two master’s degrees from the University of Southampton and Acadia University, as well as many specialized certifications, Ms. Rivers understands the power of knowledge. In preparation for her battle to survive, she conducted extensive, meticulous research. This led her to a combination of treatments including chemotherapy, improved nutrition, and integrative therapies which have helped her improve and lead an active life that includes hormone therapy.

In 2019, Ms. Rivers used her background in finance, education, and non-profit leadership to launch The Chrysalis Initiative which helps to address treatment disparities and inequities and improve breast cancer outcomes by providing education and navigational support for patients and providers. She also harnesses her knowledge and expertise to benefit several advocacy organizations where she serves on the board and holds other positions.

Ms. Rivers is currently the CFO at Educationworks, Inc. She and her husband, Rick, have three children and reside in Pennsylvania.

Phil Green

When Phil Green was diagnosed with ALS in August of 2018, he immediately dedicated himself to making a difference in the fight against this horrific disease. As a former University of Washington football player on the 1991 national championship team, he knows the value of perseverance. He committed the next 25 years to building a successful career leading companies and teams to develop innovative technology solutions that helped brands such as Sony, Hewlett Packard, and Home Depot.

Today, Mr. Green applies this same dedication, knowledge, and work ethic to help multiple ALS organizations increase awareness of the condition, promote legislation, and raise funds. This devotion extends to a wide array of organizations that span the advocacy, biotech, and research sectors. These include Augie’s Quest, Team Gleason, I AM ALS, the International Alliance of ALS/MND Associations and others where he serves in a variety of leadership and advisory roles.

Mr. Green retired as the VP of Digital Innovation at Beeline Group and lives in California with his wife, Jennifer, and their four children.

Nuru Noor

Nuru Noor’s decision to go into medicine was shaped at an early age by witnessing the impact that medical conditions like diabetes and cancer had on his close family members. These profound, personal experiences left him with a deep appreciation for the challenges faced by both patients and caregivers. It also fueled a commitment for working with people to help them improve their quality of life and minimize the impact of medical conditions on their day-to-day activities. Now, as a fellow at the Cambridge University Hospital NHS Trust in Cambridge, U.K., Mr. Noor combines his insight as a caregiver with his education and proficiency in medicine. He has also worked at a number of volunteer organizations, including a stroke rehabilitation group where he helped people set their targets and meet physical activity goals.

Mr. Noor believes clinical trials should be inclusive and a part of standard clinical care for all patients. His view is that research questions and interventions should address areas of unmet need and that trials should aim to answer questions most important to patients and caregivers. Mr. Noor’s goal is to make a significant contribution that supports his passion for more efficient clinical trial designs. This, in turn, will help to ensure patients receive better treatments at a much faster rate.

CTTI Announces New Playbook for Designing High-Quality, Diverse COVID-19 Trials

Posted on by Hannah Faulkner

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:

  1. Learn from the past and what’s being done now
  2. Make the time to design right, but move quickly
  3. Adequately power trials
  4. Randomize trials
  5. Maintain ethics
  6. Collaborate on study design
  7. Engage and enroll racial and ethnic minorities
  8. Use a core set of inclusion and exclusion criteria and endpoints
  9. 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.

CTTI Announces New Vision for Clinical Trials Ecosystem and Beyond: Transforming Trials 2030

Posted on by Hannah Faulkner

The time to create true and lasting change in clinical trials is now. Together, we can harness our experiences and momentum from COVID-19 to shape a future of smarter, faster research.

CTTI’s vision, Transforming Trials 2030, is that clinical trials in 2030 will be:

  1. Patient-centered and easily accessible
  2. Fully integrated into health processes
  3. Clinical trials are designed with a quality approach
  4. Maximally leveraging all available data
  5. Improving population health

Transforming Trials 2030

“Cross-system collaboration is critical to unlocking the change that has been talked about in the research community for so long,” said Pamela Tenaerts, executive director at CTTI. “This isn’t just CTTI’s vision. This is a vision to be shared by people across the entire clinical trials ecosystem and beyond, so that we can work together toward bold, system-wide transformations.”

Individuals can prioritize and partake in making Transforming Trials 2030 a reality by:

“We cannot lose the progress we’ve made during the pandemic,” added Tenaerts. “Let’s take these lessons learned, work together like never before, and build a new generation of clinical trials that more aptly benefit research, healthcare, and – most importantly – patients.”

Learn more about Transforming Trials 2030. To receive updates on the vision and CTTI’s work, sign up for CTTI’s e-newsletter or follow CTTI on Twitter and LinkedIn.

Recording Now Available: The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies Public Summit

Posted on by Hannah Faulkner

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

Posted on by Hannah Faulkner

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.