Case Study: DCRI Streamlines Protocol Using Quality by Design Thinking
Author: Hannah Faulkner
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 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
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
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”.
Webinar Recording Available: Listen to Adapting Clinical Trials during COVID-19: Solutions for Switching to Remote and Virtual Visits
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.