Formats

Open Comment Opportunity on CTTI’s Master Protocol Draft Resources

Posted on by Hannah Faulkner

Amid the COVID-19 pandemic, the value of master protocol studies has become clear: we need agile clinical trials that foster collaboration to address major public health threats and ongoing research challenges. CTTI invites members from across the clinical trials ecosystem to provide feedback on its draft resources to help drive the appropriate use of master protocols in diverse therapeutic areas.

Master protocols studies have the potential to more efficiently ask and answer scientific questions – ultimately, getting the right drugs to patients more quickly. However, many organizations lack experience in running master protocol studies, presenting major study design and operational challenges.

CTTI is addressing this gap by developing publicly available resources to support sponsors, patient advocacy groups, and others that want to design a master protocol trial. Public feedback will help shape the final materials that CTTI makes available to the public this summer.

The resources, developed by experts and other stakeholders across the clinical trials ecosystem, include:

  • Master protocols roadmap
  • FDA engagement tool
  • Business & operations plan template
  • Protocol development template
  • Vendor assessment tool

Feedback is welcome until April 24 at 11:59 a.m. ET.

Webinar Recording Available: Listen to Best Practices on Conducting Clinical Trials during COVID-19

Posted on by Hannah Faulkner

During March 23-27, CTTI collected experiences from stakeholders across the clinical trials ecosystem – including insights on safety considerations, remote study visits, remote consent, consulting with IRBs, and more – related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. A recording of the March 31 webinar discussing those findings and best practices is now available.

Pam Tenaerts, CTTI, and M. Khair ElZarrad, FDA, CDER, opened the webinar by welcoming attendees and recognizing the importance of multi-stakeholder input and collaboration to move us forward during this crisis.

Sara Calvert, CTTI, then gave an overview on findings from CTTI’s recent effort to collect experiences and insights from across the clinical trials ecosystem, including best practices gleaned from participants around:

  • Keeping participants informed
  • Performing ongoing risk assessment
  • Pausing (most) new study starts and enrollment
  • Pivoting to remote study visits
  • Switching to remote monitoring
  • Documenting with COVID-19 tag
  • Communicating with IRBs

Colleen Rouse, Cleveland Clinic; David Borasky, WCG; and Cindy Geoghegan, individual patient representative/caregiver; provided unique perspectives and concrete examples related to these best practices. Among the many insights, the presenters unanimously underscored that “ensuring the safety of trial participants is paramount” and communicating with patients is critical.

View a full slide deck from the webinar to read more from each presenter.

To stay up to date on all of CTTI’s work around COVID-19, including this effort and future ones, please sign up to receive our e-newsletter and follow us on LinkedIn and Twitter.

Webinar on Best Practices on Conducting Clinical Trials during COVID-19

Posted on by Hannah Faulkner

This week, stakeholders from across the clinical trials ecosystem submitted experiences and insights related to the FDA’s new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. The Clinical Trials Transformation Initiative (CTTI) collated the feedback – including insights safety considerations, remote study visits, remote consent, consulting with IRBs, and more – and will share the findings and best practices via a webinar on Tuesday, March 31 at 11:15 a.m. ET.

M. Khair ElZarrad, FDA, CDER, will provide opening comments and a  full discussion on the findings, along with detailed examples of best practices, will be presented by:

  • David Borasky, WCG
  • Sara Calvert, CTTI
  • Cindy Geoghegan, Individual Patient Representative/Caregiver
  • Colleen Rouse, Cleveland Clinic
  • Pamela Tenaerts, CTTI

By exchanging best practices and insights, we can continue our important work to develop needed medical products during this situation, and perhaps even glean some opportunities to do clinical trials better, now and in the future.

Webinar Now Available: Findings & Reflections from CTTI’s ICH E6 Renovation Work

Posted on by Hannah Faulkner

A recording is now available of a CTTI webinar on new stakeholder-informed research to identify areas within ICH E6 GCP that are in the greatest need of renovation. The webinar, held Thurs., March 19, included several perspectives about how this research could further the international conversation about ICH E6 GCP:

  • Celia Witten (FDA, CBER)
  • Amy Corneli (CTTI)
  • Dagmar Gortz (Janssen)
  • Pamela Gonzalez (University of Chicago)

Witten provided an overview of the ICH revision processes and expected timelines as well as the guiding principles behind the effort. She said that the knowledge gained by learning from stakeholder experience and viewpoints will further enrich ongoing expert working group discussions. “It’s quite valuable to us and lights the way to highlight certain areas that need more attention,” said Witten.

Corneli provided an overview of the research methodology and findings. She highlighted the three modes of the project: an online survey; qualitative, in-depth telephone interviews; and an open-comment platform. The research included the perspectives of more than 300 research professionals in 20 different global regions.

One of the key themes that stakeholders identified was that researchers need flexibility depending on the type of research being conducted and simplification of guidelines so that more investigators adhere to them. Transparency in the transition process and ensuring that a variety of stakeholders guide the process were also identified as priorities.

Gonzalez provided her thoughts on the research from the academic clinical site perspective. “The themes and the results of the survey are aligned with my own thoughts. There is a need for more flexibility. We need to have better alignment with the risk in protocols,” she said.

Gortz spoke through the lens of her industry role. She emphasized the need for case examples that could help illustrate how to use guidelines. “I was pleased to see the strong desire and strong ask for stakeholder engagement in the revision process for the guidelines,” she said.

Explore this research further by reading our executive summary, interview findings, survey findings, and open comment findings.

Share Your Experiences Related to the New FDA Guidance on COVID-19

Posted on by Hannah Faulkner

CTTI Will Collect, Share Findings & Best Practices at a March 31 Webinar

Last week, the FDA issued new guidance on the conduct of clinical trials of medical products during the current COVID-19 pandemic. While we never could have imagined conducting clinical trials in this situation, by working together and listening to each other’s experiences, we can identify best practices for continuing to conduct important clinical trials and ensuring the safety of participants.

This is where you come in. We need everyone involved in clinical trials right now – IRB professionals, investigators, coordinators, monitors, sponsors, participants, and others – to share your experiences and insights, in context of the new FDA guidance, on issues such as safety monitoring, remote data capture, etc. What have you tried? What works well? What have you thought of doing but have not tried yet?

The Clinical Trials Transformation Initiative (CTTI) will collect all experiences and input by Thursday, March 26 at noon ET, aggregate your feedback, and summarize best practices and insights. We will publically share this information via a webinar (password: ctti) on Tuesday, March 31 at 11:15 a.m. ET.

By exchanging best practices and insights, we can continue our important work to develop needed medical products during this situation, and perhaps even glean some opportunities to do clinical trials better once this public health crisis has passed.

Thank you – we look forward to hearing from you and hope you can join our webinar on March 31.

New CTTI Paper Outlines Risk Factors to Aid in HABP/VABP Pediatric Trial Enrollment

Posted on by Hannah Faulkner

A CTTI paper recently published in the Pediatric Infectious Disease Journal sheds light on risk factors that make children more likely to contract hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP).

These risk factors are important because they could aid in earlier and more accurate diagnosis of HABP/VABP, alleviating roadblocks to enrollment in HABP/VABP clinical trials. Improved enrollment could help speed the development of new antibiotics for HABP/VABP, which can often be deadly for children.

The paper details a study conducted by the Pediatric Trials Network in collaboration CTTI, which used pediatric patients’ electronic health records to identify which patients received qualifying respiratory support or antibiotics for either a lower respiratory infection or undifferentiated sepsis. The study then followed the selected patients until they were either diagnosed with HABP/VABP or discharged from the intensive care unit.

Of 862 newborns, infants, and children younger than 18 who were evaluated, 10 percent of patients receiving respiratory support and 12 percent overall developed HABP/VABP. While risk factors varied by age group, patients showed increased odds of developing HABP/VABP if they:

  • Were older
  • Were shorter
  • Spent a longer time in the intensive care unit
  • Were at risk of aspiration
  • Had received a blood product transfusion in the prior seven days
  • Had frequent suctioning

Increased attention to patients with these high-risk features could lead to improved identification of eligible participants in HABP/VABP antibiotic trials.

Learn more about CTTI’s work to improve the feasibility of HABP/VABP clinical trials.