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