CTTI News

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”.

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.

FDA to Organize Two-Day Web Conference with CTTI to Gather Feedback from Stakeholders to Update ICH E6

Posted on by Hannah Faulkner

The International Council for Harmonisation (ICH) is revising ICH E6 Good Clinical Practice (GCP) and requests stakeholder feedback to inform the process. The U.S. Food and Drug Administration, in collaboration with CTTI, will help connect the issues by organizing a free two-day public web conference for discussion of ICH E6 on Thursday, June 4, and Friday, June 5, from 10:00 a.m. – 1:00 p.m. EDT.

This public web conference, “Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice,” will help the ICH Expert Working Group (EWG), which is tasked with updating this guideline, learn from stakeholder experiences with the current GCP guideline (ICH E6(R2)). The conference will also allow the EWG to reflect on the guideline’s applicability to the changing clinical trials landscape. Topics for discussion will include:

  • Experiences with applying the current guideline to clinical trials
  • Applying GCP to innovative trial designs
  • Digital technology tools and GCP
  • Other topics relating to GCP

This stakeholder engagement web conference will help inform the discussions of the EWG as the group works on developing a responsive updated guideline. Members of the EWG will provide an overview of the ongoing work to update the guideline and will subsequently hear presentations from multiple stakeholders on their experiences with ICH E6(R2).

The registration process gives registrants an opportunity to submit questions. We will address themes from questions submitted before Tuesday, May 26, during a session on Friday, June 5. Please note the following regarding question submissions:

  • Submissions must be in English.
  • Anyone can submit questions or comments.

Time slots for stakeholders to provide oral comments during the second day of the web conference are now filled. Please consider submitting questions when registering or sending written comments to cttievents@dm.duke.edu (External Link Disclaimer).

For additional information on the ICH E6 revision efforts, please see the ICH E6(R3) Concept Paper and other materials at www.ich.org. Meeting details are available on FDA’s website.

Register today!

CTTI Report Finds Contracting and Budgeting are Significant Pain Points for Study Start-Up

Posted on by Hannah Faulkner

It’s no secret that the entire clinical trials ecosystem is affected by painfully slow study start-up timelines. CTTI recently sought to investigate the factors that influence this crucial problem. After conducting a literature scan, in-depth conversations with sites and sponsor groups, and a working group meeting, CTTI released a report showing that budgets and contracts are significant contributors to delays.

During exploratory conversations, CTTI repeatedly heard from stakeholders that several process, infrastructure, and motivational factors influence timely budget and contract negotiations:

  • The language in clinical trial contracts or clinical trial agreements (CTAs) varies considerably among sponsors and may be subject to interpretation. Indemnification, intellectual property, publication rights, subject injury, and confidentiality continue to be contentious topics, often delaying timelines in order to reach an agreement.
  • Further complicating the issue is the variability of infrastructure and resources among organizations. Limited or inexperienced staff, personnel turnover and/or the lack of investment in streamlining technology can influence the efficiency of the process.
  • Motivational factors may also influence budget and contract negotiation timelines. For example, having a key opinion leader in a trial or participating in a blockbuster trial are potential motivators.
  • Sites often reported feeling underpaid for their time and resources, while sponsors noted unintended administrative costs, site overhead fees and/or additional expenses outside the intended protocol budget.

Based on the findings, the working group determined that streamlining clinical trial budgets would be more feasible and have a greater potential impact than streamlining contracts. Three potential areas for improvement include infrastructure and resource needs, communication and transparency, and budget review and negotiation methods.

CTTI hopes the findings from this initial research will spur further conversation on improving budget and contract processes in study start-up and motivate others to continue the search for sustainable solutions. Read the full report.

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.