Ensuring Quality

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.

CTTI Paper Highlights Clinical Criteria that Can Help Identify Patients at High Risk of HABP/VABP

Posted on by Hannah Faulkner

Although treatment of possible nosocomial pneumonia is common with patients in the intensive care unit (ICU) receiving respiratory support, more than half of those treated do not fit the standard clinical definitions of hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP). A new CTTI paper available online in CHEST® Journal, accompanied by an insightful editorial, “Heeding the Prophetic Call,” outlines how the use of simple clinical criteria may help to identify high-risk patients earlier and aid future research to improve prevention and treatment.

 

The paper highlights the Prospective Identification of Pneumonia in Hospitalized Patients in the ICU (PROPHETIC) study, a large, contemporary, prospective cohort clinical trial designed by CTTI that made several key observations.

 

“HABP/VABP is associated with high mortality and morbidity and may be caused by multidrug-resistant pathogens,” said John Farley, director of the Office of Infectious Diseases at the FDA.   “Conducting clinical trials in HABP/VABP is challenging, and data to understand the patient population is critical to improve trial feasibility.”

The study sought to define the incidence of HABP/VABP in an ICU population and identify characteristics associated with the development of HABP/VABP to inform the design and conduct of future clinical trials.

The study determined that 32 percent of 4,613 prospectively identified high-risk patients received antibiotics for possible HABP/VABP. It was also determined that only 12 percent of the aforementioned high-risk patients fit the FDA Guidance standard clinical definition of HABP/VABP.

“These findings indicate that the burden of HABP and VABP is significant and there is also some concern about antibiotic overprescription in this high-risk population,” said Vance Fowler, professor of medicine at Duke University. “Receiving antibiotics is itself a risk factor for developing pneumonia, carries risks of adverse events, and may preclude eligibility for HABP/VABP clinical trial enrollment.”

Additionally, the manuscript highlights the common characteristics and treatment exposures researchers identified that were associated with increased odds of developing HABP/VABP in high-risk patients.

“Application of the study results to prospectively identify patients at highest risk for HABP/VABP may help to facilitate the conduct of innovative and efficient clinical trials,” said Pamela Tenaerts, executive director of CTTI. “This will help to promote development of optimal preventive, diagnostic, and treatment strategies to improve management of this disease.”

Learn more about CTTI’s work on HABP/VABP Studies.

Recording Now Available: CTTI Releases New Resources for Adoption of a Quality by Design Approach

Posted on by Hannah Faulkner

A recording is now available of the public webinar held on Thurs., Nov. 12 to launch CTTI’s new resources for implementing a Quality by Design (QbD) approach to clinical trials. The webinar was led by Greg Pennock, EMD Serono; David Rodin, Amici Clinical Research; Karlin Schroeder, Parkinson’s Foundation; Ansalan Stewart, FDA; and Steve Young, CluePoints.

“We have worked with leaders and all stakeholders across the clinical trials ecosystem to develop new resources that can help research organizations appropriately plan and design clinical trial protocols by implementing, and thus demonstrating the value of Quality by Design,” said CTTI Executive Director Pamela Tenaerts, MD, MBA. “These new tools aim to help researchers implement QbD into their trial – an efficient approach that will help them focus on what matters most in their trial and proactively address important risks to patient safety and the credibility of trial results.”

The specific resources that CTTI released include:

  • QbD Maturity Model: This self-assessment tool can be used by organizations to assess their current implementation of QbD, and to identify a desired future state.
  • Metrics Framework: This QbD Metrics Framework provides nine example metrics that can help key stakeholders in clinical research organizations to self-evaluate QbD implementation and guide continuous improvement efforts.
  • Implementation Guide: This resource helps study teams plan and evaluate their implementation of QbD for an individual clinical trial, and is intended to serve as a guide to key elements of QbD that will often be important to incorporate in trial planning and execution.
  • Documentation Tool: This tool helps study teams capture and communicate decisions about what is critical to quality and how the most important risks will be addressed.

CTTI’s QbD toolkit serves as a one-stop-shop for any individual or organization looking to implement QbD, and may help meet the anticipated new guideline for ICH E8(r1), which is expected to be finalized in 2021 and emphasizes a QbD approach to trial design.

Both the webinar and the new resources can be found on the CTTI website.

CTTI to Release New Resources for Adoption of a Quality by Design Approach During Nov. 12 Webinar

Posted on by Hannah Faulkner

CTTI will host a public webinar, Accelerating Evidence Generation: New CTTI Resources for Implementing a QbD Approach to Clinical Trials, on Thurs., Nov. 12.

“We have worked with leaders and all stakeholders across the clinical trials ecosystem to develop new resources that can help research organizations appropriately plan and design clinical trial protocols by implementing, and thus demonstrating the value of Quality by Design,” said CTTI Executive Director Pamela Tenaerts, MD, MBA. “These new tools aim to help researchers implement QbD into their trial – an efficient approach that will help them focus on what matters most in their trial and proactively address important risks to patient safety and the credibility of trial results.”

The specific resources that CTTI will release include:

  • QbD Maturity Model: This self-assessment tool can be used by organizations to assess their current implementation of QbD, and to identify a desired future state.
  • Metrics Framework: This QbD Metrics Framework provides nine example metrics that can help key stakeholders in clinical research organizations to self-evaluate QbD implementation and guide continuous improvement efforts.
  • Implementation Guide: This resource helps study teams plan and evaluate their implementation of QbD for an individual clinical trial, and is intended to serve as a guide to key elements of QbD that will often be important to incorporate in trial planning and execution.
  • Documentation Tool: This tool helps study teams capture and communicate decisions about what is critical to quality and how the most important risks will be addressed.

These new resources expand CTTI’s existing QbD toolkit, which serves as a one-stop-shop for any individual or organization looking to implement QbD, and may help meet the anticipated new guideline for ICH E8(r1), which is expected to be finalized in 2021 and emphasizes a QbD approach to trial design.

The free public webinar will begin at noon EST on Thurs., Nov. 12 and will feature the following presenters:

  • Greg Pennock, EMD Serono
  • David Rodin, Amici Clinical Research
  • Karlin Schroeder, Parkinson’s Foundation
  • Ansalan Stewart, FDA
  • Steve Young, CluePoints

Planning Decentralized Trials

Topics Included: Ensuring Quality, Innovative Trials, Patient Engagement, Site Planning

Program: Digital Health Trials

Related Projects: Developing Novel Endpoints, Selecting & Testing a Digital Health Technology, Managing Data, Supporting Sites, Interacting with Regulators

Your approach to running a decentralized clinical trial doesn’t have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be completely virtual, partially decentralized with hybrid approaches, or very similar to traditional “brick and mortar” trials.

Regardless of where your trial is on the decentralized spectrum, CTTI's recommendations can help you plan and conduct a successful trial.

Resources

Regulatory Submissions + Approvals | CTTI News

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

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...
Regulatory Submissions + Approvals | CTTI News

CTTI to Host Jan. 13 Public Summit, The Fastest Path to Effective COVID-19 Treatments: Using Master Protocol Studies, Featuring Research & Healthcare Leaders

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...
Regulatory Submissions + Approvals | CTTI News

CTTI Paper Highlights Clinical Criteria that Can Help Identify Patients at High Risk of HABP/VABP

Although treatment of possible nosocomial pneumonia is common with patients in the intensive care unit (ICU) receiving respiratory support, more than half of those treated do not fit the standard...
Ensuring Quality | CTTI News

Recording Now Available: CTTI Releases New Resources for Adoption of a Quality by Design Approach

A recording is now available of the public webinar held on Thurs., Nov. 12 to launch CTTI’s new resources for implementing a Quality by Design (QbD) approach to clinical trials. The webinar...
Ensuring Quality | CTTI News

CTTI to Release New Resources for Adoption of a Quality by Design Approach During Nov. 12 Webinar

CTTI will host a public webinar, Accelerating Evidence Generation: New CTTI Resources for Implementing a QbD Approach to Clinical Trials, on Thurs., Nov. 12. “We have worked with leaders and all stakeholders...
Ensuring Quality | Resources

Public Web Conference Report: Stakeholder Engagement on ICH E6 Guideline for GCP

Public Web Conference Report: Stakeholder Engagement on ICH E6 Guideline for GCP
Site Planning

Planning Decentralized Trials

Your approach to running a decentralized clinical trial doesn’t have to be all or nothing. Decentralized clinical trials sit on a wide spectrum – they can be completely virtual, partially...
Regulatory Submissions + Approvals | CTTI News

Navigating the New Normal: CTTI Announces Playbook on Best Practices for Conducting Trials During COVID-19

As the world adapts to the COVID-19 pandemic, CTTI is leading the charge to help the clinical trials ecosystem evolve and move forward. Since March 2020, CTTI conducted a...
Regulatory Submissions + Approvals | CTTI News

Recording Now Available: Strategies for Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Trials

Given the recent statistics showing that COVID-19 disproportionately affects racial and ethnic minority communities, the recruitment and enrollment of diverse populations are crucial. In a webinar from Thurs., June 18,...
Ensuring Quality | CTTI News

Web Conference Recordings Available: Listen to Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

A recording for FDA and CTTI’s two-day Pan-American web conference held June 4-5, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” is now available. Khair ElZarrad, FDA, and Pamela...

Formats

Stage of Trial

Navigating the New Normal: CTTI Announces Playbook on Best Practices for Conducting Trials During COVID-19

Posted on by Hannah Faulkner

 

As the world adapts to the COVID-19 pandemic, CTTI is leading the charge to help the clinical trials ecosystem evolve and move forward. Since March 2020, CTTI conducted a series of initiatives to help the research community successfully navigate the challenges associated with adjusting trials that were underway when the pandemic hit. These initiatives and resulting best practices are captured in a new playbook, Best Practices for Conducting Trials During the COVID-19 Pandemic.

CTTI gathered experiences and learnings from across the clinical trials ecosystem via public surveys and discussions, and communicated these findings during two CTTI-hosted webinars. These efforts extrapolated best practices for conducting clinical trials with new FDA guidance on COVID-19, as well as solutions to help investigators shift to remote and virtual visits during the COVID-19 pandemic.

Through this initial work when the pandemic first hit, CTTI identified eight essential best practices on how to conduct clinical trials during the pandemic. These key points, fully outlined in the new COVID-19 playbook, recommend that stakeholders:

  1. Keep participants informed
  2. Perform outgoing risk-benefit assessment
  3. Communicate with IRBs and regulatory authorities
  4. Adjust new study starts and enrollment based on risk
  5. Pivot to remote study visits
  6. Switch to remote monitoring
  7. Be flexible
  8. Document everything with COVID-19 tags

The new document provides detailed information on how stakeholders can best integrate these important recommendations into their ongoing clinical trials while providing several additional resources to fully support these efforts. This comprehensive resource will help researchers adapt to the changing clinical trial landscape and continue to conduct successful studies during the pandemic.

Recording Now Available: Strategies for Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Trials

Posted on by Hannah Faulkner

Given the recent statistics showing that COVID-19 disproportionately affects racial and ethnic minority communities, the recruitment and enrollment of diverse populations are crucial. In a webinar from Thurs., June 18, “Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials,” CTTI discussed the barriers to enrolling a diverse patient population and key strategies to overcome them. The presentation and full slide deck are now available here.

The webinar covers useful insights and best practices gathered from key stakeholders across the clinical trials ecosystem, including investigators, sponsors, participants, and many others.

Presenters included:

  • Christina Brennan, Northwell Health
  • Richard Knight, American Association of Kidney Patients
  • Fabian Sandoval, Emerson Clinical Research Institute
  • Anand Shah, FDA, OC
  • Cassandra Smith, Janssen

Several CTTI efforts are underway—including conducting surveys, holding webinars, and developing resources to help the clinical trials ecosystem adapt and move forward during this pandemic.

Web Conference Recordings Available: Listen to Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

Posted on by Hannah Faulkner

A recording for FDA and CTTI’s two-day Pan-American web conference held June 4-5, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” is now available.

Khair ElZarrad, FDA, and Pamela Tenaerts, CTTI, opened the web conference by welcoming attendees. Then, FDA and CTTI shared background on ICH E6 and the plan to engage with stakeholders to inform the discussions of the ICH Expert Working Group (EWG), which is tasked with updating the guideline and making it more responsive to advances in clinical trial design and conduct. Multiple stakeholders then shared their experiences with ICH E6(R2). Overall, the web conference was a testament to the importance of having engagement at the heart of the development of E6.

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

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