Conducting Clinical Trials During Covid-19 Webinar Presentation 3.31.2020
Author: Hannah Faulkner
New CTTI Project Aims to Increase Inclusion of Minority Populations in Clinical Trials
The lack of diversity in U.S. clinical trials limits understanding of the risks and benefits of medical products. To address this issue, CTTI is conducting a new project to demonstrate the value of engaging racial minorities, ethnic minorities, and women in clinical trials.
The objectives of this new project include:
- Identify organizational-level practices, and related metrics, that increase the inclusion of diverse patient populations in the development lifecycle of medical products.
- Identify incentives & disincentives for decision-makers to invest sufficient resources in organizational-level practices that increase diversity in clinical trials.
- Identify factors that yield a clinical, scientific, and financial return on investment from engaging diverse populations in clinical trials
CTTI will conduct in-depth interviews with key stakeholders, create real-world case studies, and develop process and outcome evaluation metrics designed to build fit-for-purpose, scalable strategies to increase diversity in clinical trials.
By collecting data that demonstrates the importance of including underrepresented patient populations, CTTI aims to help increase the participation of diverse populations throughout the development lifecycle of medical products.
CTTI Paper Discusses Development of Patient Group Engagement Tool to Benefit Clinical Trials
Patient groups can offer sponsors a wealth of support that can boost clinical trial efficiency but there are few frameworks to help identify priorities. In a new preprint manuscript, CTTI discusses the development and application of an evidence-based prioritization tool to help sponsors and patient groups identify mutually beneficial engagement activities.
Using a list of 31 engagement activities previously developed through its Patient Groups and Clinical Trials (PGCT) work, CTTI conducted qualitative, semi-structured interviews with representatives from patient groups and sponsor organizations to refine the list to 24 unique engagement activities across the medical product development lifecycle.
The findings were used to develop the web-based tool, which helps sponsors and patient groups identify mutually relevant, high-priority engagement activities.
The manuscript explains how the tool walks users through a three-step decision-making process that results in a visual priority matrix grid. It helps sponsors and patient groups form meaningful partnerships and solidify expectations, goals, and specific roles that will benefit the design, conduct, and dissemination of research, in alignment with CTTI’s recommendations [link] for effective patient group engagement.
Read the full manuscript.
CTTI Paper Discusses Suitability of Patient Registries for Embedded Clinical Trials
Embedding clinical trials into patient registries can lead to high-quality, efficient prospective research. However, methods for assessing which registries are appropriate to serve as the platform for the conduct of a clinical trial can be problematic for researchers. A new CTTI paper in Therapeutic Innovation & Regulatory Science identifies and describes the essential characteristics, processes, and practices required to embed and conduct registry-based clinical trials to support regulatory decision-making.
Taking an evidence-based, collaborative approach, CTTI completed a comprehensive review of registry-embedded clinical trials and worked with the Research Triangle Institute (RTI) to conduct 25 expert interviews. These efforts were followed by a multistakeholder meeting with 42 members of academia, industry, government, and patient advocacy organizations.
The resulting data indicates that registries can create a sustainable and reusable infrastructure to support embedded clinical trials when certain characteristics are present including relevancy, robustness, reliability, and assurance of patient protections.
What’s more, registry-embedded clinical trials offer opportunities to:
- Identify high-quality sites
- Reduce duplicative data and site workload
- Recruit patients efficiently
- Reduce lost to follow-up incidents
- Enhance timelines
- Reduce costs
CTTI noted a prevailing need for guidance on how to assess the suitability of existing registries and plan new registries that can support embedded clinical trials. The paper includes CTTI recommendations, suggested practices, and decision trees that help meet this need. These resources are designed to help clinical trial stakeholders effectively leverage patient registries to create high-quality, embedded clinical trials that benefit relevant patient populations.
CTTI Feasibility Studies Database Adds New Resources
CTTI has added 172 new studies to its Feasibility Studies database, bringing the total number of resources up to more than 440 studies. This free, one-of-a-kind repository of feasibility studies using digital health technologies to capture data in clinical research can help the entire clinical trials community to better match appropriate technologies to their research goals.
For example, sponsors can use the resource to help support trial design, while investigators in the field can use it to make decisions regarding which technology would be most useful for their research. This centralized repository could also help alleviate future development of redundant studies and contribute to the design and implementation of high quality, efficient trials.
The database includes a systematic search of scientific literature indexed in PubMed and published between January 2014 and June 2019.
Do you know about a study we should add to the database? CTTI invites others in the digital health trials community to submit relevant studies on an ongoing basis.
Recording Now Available: Strategies for Engaging Racial and Ethnic Minority Patient Populations in COVID-19 Trials
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.