Author: Hannah Faulkner

Recording of Public Webinar Now Available: New ICH M11 Harmonised Guideline, Protocol Template, and Technical Specification

Posted on by Hannah Faulkner

A recording for the International Council for Harmonisation’s public webinar, held January 26th, “New ICH M11 Harmonised Guideline, Protocol Template, and Technical Specification,” is now available.  

The webinar opened with welcoming remarks from Jacqueline Corrigan-Curay  of the U.S. Food & Drug Administration (U.S. FDA). Following the opening remarks, members of the M11 Expert Working Group—including Janice Maniwang of the U.S. FDA, Noémie Manent of the European Medicines Agency (EMA), and Mitzi Allred of Merck—provided detailed overviews of the M11 Guideline, Protocol Template, and Technical Specification. Following the presentations, the speakers also addressed questions that had been submitted during webinar registration. The webinar concluded with closing remarks from Ronald Fitzmartin of the U.S. FDA.    

View the full slide deck to learn more about the M11 Guideline, Protocol Template, and Technical Specification. The U.S FDA public consultation period opened on Thurs., Dec. 22, 2022 and will close on Tues., Feb. 21, 2023. Comments may be submitted on Regulations.gov. 

For additional information on the ICH M11 Guideline, please see the ICH Guidelines site, M11 Draft Guideline, M11 Template, and M11 Technical Specification. 

ICH Public Webinar Will Provide an Update on the Latest Developments Concerning the M11 Harmonised Guideline and Protocol Template

Posted on by Hannah Faulkner

The International Council for Harmonisation (ICH) M11 Expert Working Group (EWG) is organizing a public webinar to describe the latest developments on the ICH M11 Guideline. The EWG is holding this webinar on Thursday, Jan. 26, 2023 from 10:00 a.m. – 12:00 p.m. EST. Registration is open for this event, and registrants are invited to submit questions about this webinar in English using this form by Friday, Jan., 20, 2023. All information and presentations will be provided in English.

Click here to register for the webinar.

The webinar will include the following speakers from the ICH M11 committee:

  • Janice Maniwang, U.S. Food and Drug Administration (FDA)
  • Noémie Manent, European Medicines Agency (EMA)
  • Mitzi Allred, Merck

During the webinar, these speakers will describe the latest developments on the M11 Guideline, Protocol Template, and Technical Specification; explain the benefits and opportunities created by the M11 Protocol Template; explain how the Protocol Template was developed; and explain the purpose of the technical specifications in supporting the exchange and storage of clinical trial data. There will also be a Q&A session at the end of the webinar during which the speakers will address a selection of questions submitted during registration.

For additional information on the ICH M11 Guideline, please see the ICH Guidelines site, M11 Draft Guideline, M11 Template, and M11 Technical Specification.

Patient Engagement Collaborative Announces Eight New Members

Posted on by Hannah Faulkner

Today, the U.S. Food and Drug Administration (FDA) and the Clinical Trials Transformation Initiative (CTTI) announced eight newly selected representatives for the Patient Engagement Collaborative (PEC). The group of 16 patients, caregivers, and patient group representatives will meet with the FDA several times a year to discuss topics such as communication, transparency, and the best ways for patients to engage the FDA about medical product regulation. Those selected to the PEC are expected to serve for two years. 

The eight new representatives are:  

  • Kim Hindery 
  • Yasmin Ibrahim 
  • Seth Morgan 
  • Cara O’Neill 
  • Ceciel Rooker
  • Christina Sisti
  • Trina Stelly
  • Lauren Youngborg

The representatives were selected from 75 applications received in response to a Federal Register notice published in September 2022. These new members of the PEC include patients who have personal disease experience, caregivers who have personal experience supporting someone with a health condition, and representatives from patient groups who have direct or indirect disease experience. The selection committee, which included patient advocates, FDA staff from multiple centers, CTTI staff and several outgoing PEC members, worked to identify individuals with diverse perspectives and experiences who could meaningfully contribute and express the patient voice. 

“CTTI is delighted to welcome the new members of the PEC and we sincerely appreciate the contribution of those outgoing members and extend our deepest thanks for their dedication and service,” said Sally Okun, CTTI’s executive director. “Including patients as equal partners in clinical research is a foundational value of CTTI. Discussions with the PEC contribute to advancing our vision of Transforming Trials 2030, in particular our first pillar: ‘to make clinical trials patient-centric and easily accessible’.” 

The PEC, a collaboration established by FDA and CTTI in 2018, is a group of patient organizations and individual representatives who discuss ways to enhance patient engagement. FDA and CTTI collaborate to involve representatives with a variety of perspectives including patients, caregivers and representatives from diverse patient organizations and communities. The PEC is run by the FDA’s Patient Affairs, which is dedicated to providing an inviting, welcoming and meaningful experience for patient communities to engage with the FDA. 

“Understanding patients’ experiences is critical to support medical product regulation and help ensure safe, effective and innovative medical products are available for patients. The PEC is an important opportunity for individuals to share their experience with the FDA. The FDA listens closely to feedback from individuals in the PEC and uses the insight from the PEC to enhance engagement opportunities and provide a platform for patients’ voices to be heard,” said Andrea Furia-Helms, M.P.H., Director of Patient Affairs, Office of Clinical Policy and Programs, FDA.   

Going forward, the PEC will continue the dialogue around how patient perspectives can inform and enhance the clinical trials enterprise. Previous topics have included: creating new ways to collaborate with patient communities; making patient engagement more systematic; improving transparency through education and outreach; and enhancing communication between the FDA and patient communities. 

The FDA and CTTI wish to thank the outgoing members for their service to the PEC over the past several years: 

  • Ronald Bartek 
  • Anne Hall 
  • Elizabeth Joniak-Grant 
  • Isabelle Lousada 
  • Rick Phillips
  • Philip Posner
  • Lynne Quittell
  • Adrienne Shapiro

The PEC has worked tirelessly to incorporate the patient voice in the FDA’s medical product regulatory programs. For example, the PEC has: 

  • Provided enhanced information to patient communities (e.g., for patients webpage). 
  • Created materials to help patients understand FDA’s mission and patient engagement activities. 
  • Worked to better understand COVID-19’s impact on clinical trials for other diseases and conditions through informal discussions. 
  • Worked to understand patient concerns regarding COVID-19 vaccines. 
  • Met with the European Medicines Agency’s Patients’ and Consumers’ Working Party in 2021 to exchange ideas around enhancing patient engagement, particularly incorporating youth perspectives and in 2022 to discuss COVID-19 communication.  

Since 2008, CTTI has included patient advocates on its Executive Committee, Steering Committee, and project teams and, today, nearly all of its more than 30 sets of evidence-based recommendations and associated frameworks and tools mention inclusion of patients as a critical part of the clinical trials process. 

CTTI Publication Investigates Use of Preventive Statins among Older Patients with Cardiovascular Disease

Posted on by Hannah Faulkner

A new CTTI publication, published in the Journal of the American Geriatrics Society, investigates the use of preventive, high-intensity statins among patients 75 and older diagnosed with atherosclerotic cardiovascular disease (ASCVD). The study, which used pharmacy and medical claims data from a commercial health plan, found substantial underuse of statins among insured ASCVD patients. Less than half of older adults with ASCVD, who are at the highest risk of vascular events like heart attack or stroke, are taking statins. Only a minority of older patients are taking high-intensity statins, and very few are taking non-statin ASCVD treatments. Notably, women and patients who had a diagnosis of cerebrovascular disease (CeVD) or peripheral arterial disease (PAD) were less likely to be prescribed a statin. This paper was based on exploratory work done by CTTI with Duke and HealthCore to assess patient use of ASCVD therapies, with a focus on high-intensity statins, to identify areas where future clinical trials and/or quality improvement initiatives can be targeted to address treatment gaps between clinical practice and guideline recommendations. 

CTTI Thanks Our Amazing Community for its Contributions to Our Work This Year

Posted on by Hannah Faulkner

In 2022, our organization embraced innovation at the intersection of science, culture, disciplines and people. We believe it’s the crossroads of where change and creativity occur and it has led us to reaffirm our commitment to doing clinical research differently. Through diverse collaboration and unique approaches, we are making great progress in our efforts to create solutions that change how clinical trials are designed and run and, ultimately, improve the health of people. 

Before this year draws to a close, we want to take a moment to express our sincere gratitude for the knowledge, ideas and talent you’ve contributed to our work. We are grateful for the ways you push us to work smarter. And we are privileged to work with the many diverse experts and stakeholders through whom we explore challenges and create solutions that we couldn’t arrive at alone.  

Some of the accomplishments you’ve helped make possible this year include: 

We are proud to have you as part of this amazing community. Although the road to transforming clinical trials by 2030 is long and complicated, it is through our collaboration that we will reveal sustainable, lasting change that improves health care for all. 

We look forward to working with you in 2023 and wish you the best this holiday season and in the New Year! 

Recording Now Available: CTTI Webinar Unveiling New Recommendations on Embedding Clinical Trials into Clinical Practice

Posted on by Hannah Faulkner

A recording of CTTI’s December 15 webinar unveiling the new recommendations on embedding clinical trials into clinical practice is now available. 

The one-hour webinar includes a welcome from Sally Okun, CTTI Executive Director; a keynote
presentation from Robert M. Califf, U.S. Food & Drug Administration; a project overview from Matthew Roe, AstraZeneca; and a panel discussion moderated by Lindsay Kehoe, CTTI Senior Project Manager. The panel discussion, which focused on stakeholder perspectives related to the
integration of the new recommendations, included: Sam Bozzette, National Institutes of Health;
Lara Jehi, Cleveland Clinic; Holly Robertson, Medidata; and Alandra Weaver, Crohn’s & Colitis
Foundation. 

The goal of creating these recommendations for embedding elements of clinical trials into care is to reduce trial inefficiencies and enable faster, more representative, evidence generation that improves patient care. The recommendations were developed for trials of drugs, devices, and biologics in close collaboration with stakeholders across the clinical trials enterprise. The first phase involved gathering input through qualitative, in-depth interviews with designers and implementers of interventional clinical trials that are embedded into clinical practice. The recommendations were drafted and refined with input from a multi-stakeholder project team and through Expert Meetings. 

View the slide deck to read more.