Quality

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:

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!