Stakeholders across the clinical trial ecosystem have committed to addressing healthcare disparities and working together to increase diversity, equity and inclusion (DEI) efforts for clinical trials. In 2020, the US Food and Drug Administration (FDA) issued finalized guidance to enhance the diversity of clinical trial populations. Other industry organizations are also putting forth programs and guidelines, such as the Pharmaceutical Research and Manufacturers of America (PhRMA) industry-wide principles on clinical trial diversity.

Even with heightened awareness of the importance of DEI in clinical trials, many are falling short. One study showed that, from July 2011 to June 2020, only 230 US-based vaccine clinical trials with a total of 219,555 participants met the criteria for inclusion.

Health equity requires that clinical trial participants include a wide range of patients from diverse communities. Because people can experience disease differently, clinical trials need to reflect diverse populations, including race, ethnicity, sex, geographical location and, often, age. Socioeconomic status (SES) can also be a significant predictor of health outcomes. However, an analysis of all randomized clinical trials published in 2015 and 2019 in the Journal of the American Medical Association, The Lancet and the New England Journal of Medicine found that less than 15% of studies reported on the SES of trial participants.

DEI efforts in clinical trials work to:

Reduce biases.
Ensure that all communities benefit from scientific discoveries in advance.
Contribute to more innovative science.

Unfortunately, supporting DEI goals with existing phone, in-person or web recruitment, enrollment and retention strategies introduces new challenges to an already complex process.

Challenges of DEI in clinical trials

Traditional recruitment and enrollment strategies and tools don’t necessarily support equity and inclusion. When recruiting and enrolling participants, phone, in-person or web-based surveys create inherent challenges.

Among certain communities, mistrust in clinical research and medical institutions has been engendered by historical incidents, such as a failure to obtain formal agreements or to communicate the risks of a study.
Many communities and populations lack access to the resources necessary to participate in clinical trials, such as the internet, or they are not comfortable using the latest technology.
Overcoming the barriers to recruitment, enrollment and retention requires that participants can easily get answers—on demand—to questions around schedules, locations and financial implications.

Fortunately, virtual agents can help solve these challenges by giving participants easy anytime access to information and reminders right from their phones.

From July 2011 to June 2020, only 230 US-based vaccine clinical trials with a total of 219,555 participants met the criteria for inclusion. Flores LE, Frontera WR, Andrasik MP, et al., Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials, JAMA Network, Feb. 2021

Health equity requires that clinical trial participants include a wide range of patients from diverse communities.

The Gridspace Grace virtual agent enables contract research organizations (CROs) and recruitment and retention vendors to more efficiently and cost effectively recruit and retain diverse patient populations in clinical trials. By giving participants the option to use a familiar means of communication—the telephone—throughout the trial process, Grace creates an easy, comfortable experience that is personal and widely available to all populations. There is no need for internet access, computers or devices.

Also, with task-specific, next-generation conversational voice, patients have 24/7 access to a bot that can handle patient interactions consistently and compliantly in a natural and friendly manner. This can help underserved patients stay supported and on track.

Proactively engage patients throughout the study process to ease concerns.
Perform pre- and post-appointment surveys.
Provide appointment reminders.
Ensure that patients have the support they need to complete required tasks, such as completing diary entries.
Provide access to quick, easy and reliable answers to questions.

Grace provides a patient-centric experience that is indistinguishable from a capable human and creates seamless handoffs when escalation is needed. And, because Grace is purpose built for the needs of CROs and recruitment and retention vendors, Grace conforms to the same QA standards and methods as human staff while helping to ensure better procedure adherence for service consistency.

Explore how Grace can help CROs and recruitment vendors improve DEI for clinical trials.

By giving participants the option to use a familiar means of communication—the telephone—throughout the trial process, Grace creates an easy, comfortable experience that is personal and widely available to all populations.