COVID 19

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.

Webinar Recording Available: Listen to Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits

Posted on by Hannah Faulkner

A recording for CTTI’s May 20 webinar, “Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits” is now available.

Earlier this month, CTTI surveyed stakeholders to identify challenges and solutions related to switching to remote or virtual visits for clinical trials, mid-stream, amid COVID-19. It also co-hosted a survey with Evidation Health, Inc. to get insights and perspectives from patients. A recent webinar highlighted findings from both studies and shared solutions for conducting clinical research via remote and virtual visits.

Pam Tenaerts, CTTI, and Jacqueline Corrigan-Curay, FDA, CDER, opened the webinar by welcoming attendees and providing insights on the current state of conducting clinical research during COVID-19. Lindsay Kehoe, CTTI, then gave an overview on findings from CTTI’s survey, including challenges and words of wisdom from across the clinical trials community on transitioning to virtual or remote visits.

Laura Cooke, Amgen; Bray Patrick-Lake, Evidation Health, Inc.; and Ramya Thota, Intermountain Healthcare, ASCO; also shared unique perspectives from sites, patients, and sponsors, respectively. Overall, there was a strong consensus that COVID-19 has changed clinical trials in many ways, for everyone involved, and that we should apply these new virtual and remote approaches to future trials, when appropriate, post-pandemic.

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, please visit our COVID-19 page, sign up to receive our e-newsletter, and follow us on LinkedIn and Twitter.

Now Available: Searchable, Real-Time COVID-19 Clinical Studies Spreadsheet

Posted on by Hannah Faulkner

The urgent need to rapidly identify safe and effective medical therapies has led to a spike in clinical studies on COVID-19. To help the global scientific community address this need, CTTI has created a searchable spreadsheet of COVID-19-related studies posted on ClinicalTrials.gov.  The AACT COVID-19 Trials Spreadsheet is updated daily and was created from a search strategy developed by ClinicalTrials.gov and data from the Aggregate Analysis of ClinicalTrials.gov (AACT) database.

With COVID-19-related studies in one, up-to-date spreadsheet, users can easily search for and sort current information. Each study is listed as a single row in the spreadsheet and the 68 columns include information on goals, interventions, randomization schemes, masking, eligibility criteria, consent, the use of Data Monitoring Committees, etc. As of this posting, there are 1,476 COVID-related studies listed in ClinicalTrials.gov.

CTTI recently used the spreadsheet to characterize COVID-19-related clinical trials in the April 2020 Designing High-Quality COVID-19 Treatment Trials webinar. Details on the search terms used to generate the list of trials posted on ClinicalTrials.gov are also available.

CTTI Webinar on Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits

Posted on by Hannah Faulkner

The COVID-19 pandemic has caused many ongoing trials to switch to remote and virtual visits midstream, despite it being unchartered territory for many. On Clinical Trials Day, Wed., May 20, join the Clinical Trials Transformation Initiative (CTTI) for a webinar at 10 a.m. ET, to hear how stakeholders across the clinical trials ecosystem are adapting, overcoming challenges, and discovering new best standards for conducting clinical research via remote and virtual visits.

CTTI recently surveyed stakeholders to identify challenges and solutions for using telehealth for clinical trials, and co-hosted a survey with Evidation Health, Inc. to get insights and perspectives from patients. This webinar will highlight findings from both surveys, and share solutions for switching to remote and virtual visits during an ongoing trial. Jacqueline Corrigan-Curay, FDA, CDER, will provide opening remarks and presenters include:

  • Laura Cooke, Amgen
  • Bray Patrick-Lake, Evidation Health, Inc.
  • Ramya Thota, Intermountain Healthcare, ASCO
  • Pamela Tenaerts, CTTI

By exchanging experiences and ideas, we can work together to fully harness the new opportunities and benefits of using remote and virtual visits for clinical trials.

We hope you can join us for next Wednesday’s webinar.

Share Your Experiences on Switching to Remote Visits for Clinical Trials during COVID-19

Posted on by Hannah Faulkner

Now, more than ever, there is urgency to adopt telehealth for clinical research. But where do we begin?

Exchanging ideas is the first step. As a valuable member of the clinical trials community, we need your help – please tell us how your clinical trials are evolving to use telehealth (this can be using phone, Skype, or FaceTime for remote visits and/or using other telemedicine approaches) in light of the COVID-19 pandemic. What have you tried? What works well? What is challenging?

CTTI will collect experiences and input from stakeholders across the clinical trials ecosystem through Thurs., May 7 at 11:59 p.m. ET, aggregate your feedback, and summarize best practices and insights. We will publically share this information via a webinar in the near future.

By exchanging ideas on how to use telehealth in clinical trials during this pandemic, we can learn from each other and – ultimately – run better, more efficient clinical trials moving forward. Thank you and we look forward to hearing from you.

Recording Now Available: Designing High-Quality COVID-19 Treatment Trials

Posted on by Hannah Faulkner

Designing clinical trials during a pandemic presents significant challenges. However, it is possible to build trials that yield high-quality results without slowing down the process.

In a webinar from Thurs., April 23, titled “Designing High-Quality COVID-19 Treatment Trials,” a diverse group of stakeholders presented perspectives that can inform COVID-19 researchers on best practices for designing and quickly launching trials that improve quality and minimize burdens on front-line hospital staff and study participants. The slide deck and recording from this webinar are now available here.

This is the second in a series of CTTI webinars designed to provide help and direction to those seeking to improve trials related to COVID-19. The first webinar, “Identifying Best Practices for Conducting Clinical Trials with the New FDA Guidance During the COVID-19 Pandemic,” is available here.