Regulatory Submissions + Approvals

Report Now Available: Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

Posted on by Hannah Faulkner

The summary report of the web conference on “Stakeholder Engagement on ICH E6 Guidance for Good Clinical Practice,” organized by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical Trials Transformation Initiative (CTTI), is now available. The two-day Pan-American web conference was held June 4-5 with more than 1300 attendees worldwide.

The report provides an overview of the presentations from a diverse group of participants, including academic researchers, human subject protection and ethics experts, as well as patients. Members of the ICH Expert Working Group (EWG), which is tasked with updating the ICH E6 guideline, provided an overview of their approach to ensuring that the guideline is responsive to the needs of the community and that it facilitates advances in clinical trial design and conduct. The report also outlines key themes from the web conference’s line-up of stakeholders who shared their experiences with ICH E6(R2).  Further, the report also incorporates comments and input from web-conference attendees that were received via email or verbally during the web conference.

Check out the recording and the slide decks for each day of the web conference to learn more from the presenters.

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

Developing Novel Endpoints

Topics Included: Innovative Trials, Regulatory Submissions + Approvals

Program: Digital Health Trials

Related Projects: Planning Decentralized Trials, Selecting & Testing a Digital Health Technology, Managing Data, Supporting Sites, Interacting with Regulators

CTTI has described steps for selecting and developing novel endpoints from digital health technologies.

Using these recommendations and resources, you can develop novel endpoints that more accurately represent the patient experience and, therefore, may be more meaningful to patients, providers, and others.

Project Team Members

Resources

Regulatory Submissions + Approvals | Case Studies

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers

Orikami Efficiently Deploys Digital Biomarker App by Collaborating Across Providers, Patients, and Developers
Regulatory Submissions + Approvals | CTTI News

Report Now Available: Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice

The summary report of the web conference on “Stakeholder Engagement on ICH E6 Guidance for Good Clinical Practice,” organized by the U.S. Food and Drug Administration (FDA) in collaboration with the Clinical...
Regulatory Submissions + Approvals

Developing Novel Endpoints

CTTI has described steps for selecting and developing novel endpoints from digital health technologies.
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 | Resources

CTTI Novel Endpoints Interactive Selection Tool

CTTI Novel Endpoints Interactive Selection Tool
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,...
Regulatory Submissions + Approvals | CTTI News

Webinar to Share Strategies for Including Ethnically Diverse Populations in COVID-19 Trials

COVID-19 disproportionately affects racial and ethnic minority communities, and clinical trial professionals are struggling to recruit the diverse participant demographic needed to find an effective COVID-19 treatment that can work...
Regulatory Submissions + Approvals | CTTI News

Share Your Experiences: Recognizing The Need for Diversity in COVID-19 Clinical Trials

COVID-19 is disproportionately impacting racial and ethnic minority communities across the United States. We are asking everyone involved in clinical trials right now – IRB professionals, investigators, sponsors, participants, and...
Safety | CTTI News

New CTTI Publication Highlights Stakeholder Preferences for Informed Consent Language in HABP/VABP Studies

A peer-reviewed article recently published in JAMA Network Open details CTTI work to get stakeholder feedback on informed consent language for hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP) studies. The article describes the process of...
Regulatory Submissions + Approvals | CTTI News

CTTI Paper Reveals Investigator Perspectives on Advantages and Challenges of Digital Health Trials

Now more than ever, mobile technology is affecting every aspect of our lives, including the way we conduct clinical research. In a new preprint manuscript, CTTI examines the investigator experience in...

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.

Webinar to Share Strategies for Including Ethnically Diverse Populations in COVID-19 Trials

Posted on by Hannah Faulkner

COVID-19 disproportionately affects racial and ethnic minority communities, and clinical trial professionals are struggling to recruit the diverse participant demographic needed to find an effective COVID-19 treatment that can work for everyone.

To help, CTTI is hosting a webinar, Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Clinical Trials, on Thurs., June 18 at noon ET to discuss the barriers and solutions to enrolling a diverse patient population.

The webinar will summarize useful insights gathered from key stakeholders across the clinical trials ecosystem, including IRB professionals, investigators, sponsors, participants, and others. These best practices can be applied to help clinical trial teams recruit and enroll diverse populations of participants more effectively.

Anand Shah, FDA, OC, will provide opening remarks and confirmed speakers include:

  • Christina Brennan, Northwell Health
  • Richard Knight, American Association of Kidney Patients
  • Fabian Sandoval, Emmerson Clinical Research Institute
  • Cassandra Smith, Janssen

Mark your calendar today!

Share Your Experiences: Recognizing The Need for Diversity in COVID-19 Clinical Trials

Posted on by Hannah Faulkner

COVID-19 is disproportionately impacting racial and ethnic minority communities across the United States. We are asking everyone involved in clinical trials right now – IRB professionals, investigators, sponsors, participants, and others – to share their experiences and insights for creating effective strategies to engage racial and ethnic minority patient populations in COVID-19 clinical trials.

CTTI will collect experiences and input from key stakeholders across the clinical trials ecosystem through Mon., June 8 at 11:59 p.m. ET, aggregate your feedback, and summarize best practices and insights.  Findings from the survey and the webinar will later be developed into a best practices document focusing on effective strategies to engage racial and ethnic minority patient populations in COVID-19 clinical trials.

We will publically share this information via a webinar in the near future.

New CTTI Publication Highlights Stakeholder Preferences for Informed Consent Language in HABP/VABP Studies

Posted on by Hannah Faulkner

A peer-reviewed article recently published in JAMA Network Open details CTTI work to get stakeholder feedback on informed consent language for hospital-acquired and/or ventilator-associated bacterial pneumonia (HABP/VABP) studies. The article describes the process of gathering feedback from 52 stakeholders to identify the most important elements to include in the informed consent process.

Previous CTTI research suggested that an early enrollment strategy using advance consent in pneumonia antibiotic trials is acceptable to key stakeholders. As part of that research, CTTI also engaged these stakeholders to identify, describe, and reach consensus on essential concepts that should be included in an advance consent form for a HABP/VABP clinical trial. Concepts were:

  • Reassurances on patient health and treatment
  • Reasons for advance consent and enrolling early
  • Explanation of non-inferiority

The proposed consent language developed in this process, in combination with a strategy for enrolling patients at highest risk for pneumonia before infection onset, may help potential participants make informed decisions about their involvement in clinical research. It may also improve enrollment rates in trials from which data are urgently needed to evaluate new treatments and improve patient care.

Learn more about past CTTI work on HABP/VABP.

CTTI Paper Reveals Investigator Perspectives on Advantages and Challenges of Digital Health Trials

Posted on by Hannah Faulkner

Now more than ever, mobile technology is affecting every aspect of our lives, including the way we conduct clinical research. In a new preprint manuscript, CTTI examines the investigator experience in digital health trials.*

In-depth interviews conducted with 12 investigators representing an array of clinical specialties revealed the benefits and challenges of incorporating mobile technology into clinical trials through the use of smartphones, tablets, notebook computers, and wearable devices.

Some common benefits of digital health trials cited by the investigators include:

  • Streamlined study operations and data collection
  • Simplified and continuous study data capture throughout the trial
  • Improved study and data quality and an increase of “real-world” results

The manuscript also details specific challenges investigators faced when using digital health technologies in trials. These include an increase in the amount of time needed by investigators and study personnel to review data and maintain the technology, additional training, technology adoption barriers for participants and staff, and uncertainty with data validity. These potential obstacles must be proactively addressed in order to harness the full benefits of digital health trials.

Learn more about CTTI’s Digital Health Trials work.

*CTTI’s Digital Health Trials work was previously called “Mobile Clinical Trials”.