Image Credit: © Jakub Krechowicz – stock.adobe.com
Inclusion of diverse populations continues to lag in clinical research. In this article, we will focus on three key considerations when deploying technology in a clinical research trial to help increase study diversity:
- Early collaboration with study sites
- Building diversity into the design process
- Maximizing flexibility
Early collaboration with study sites
Study sites are at the nexus of the development and deployment of diverse clinical trials due to their relationships with trial participants, the local community, and sponsors. By collaborating with sites early, technology providers can find and implement solutions that will reach a diverse population of intended participants.
Site staff perform a critical role by being cultural and linguistic mediators. They can also translate and mediate technology use, ensuring that it aligns with local customs, values, and language idioms.
In clinical trials, site staff, who are closest to the patients and likely the most trusted, play crucial roles. Nevertheless, significant trust barriers persist, particularly within minority communities. To address this, site staff must be prepared to engage community members effectively. This preparation should include cultural sensitivity training and efforts to build relationships within the communities prior to discussing specific clinical trials. Assuming that site staff inherently know how to engage patients from diverse backgrounds is a mistake that could impede successful enrollment.
Sponsors and technology providers should endeavor to develop collaborative relationships with site staff. By establishing trusting relationships, they enable site staff to voice concerns and bring forth challenges early in development. Conversely, when site staff are approached regarding study feasibility, they should take the time to ask sponsors questions to ensure they truly understand what technologies will be deployed with the protocol and how those technologies will fit with their site’s workflows, and their knowledge of how best to interact with the local population. Since the sponsor usually decides on the technology all sites should use, the sponsor should clearly explain the technology expectations upfront, so that the sites can assess their ability to incorporate the technology into their workflow for a successful trial experience for the site staff and trial participants.
Reducing technology apprehension
The introduction of new technology can be a welcome sight or a new stressor for study participants. Well-trained site staff can address challenges with technology use and ensure that data collection is consistent and reliable. As site staff often have a direct and established relationship with study participants, they are usually the first point of contact and are entrusted with explaining the trial’s processes, ensuring understanding, and obtaining informed consent. Therefore, site staff can help address participants’ technology apprehension, provide assurance, and guide the use of new tools at the same time.
Data privacy concerns
New technology and ways of capturing data can elicit data privacy concerns. Different communities have varying perceptions and concerns about data privacy. If these concerns are not addressed adequately, certain groups might not participate in research. One way to address these issues is to explain clearly in plain language, which is informative and transparent, how participant data is captured and used. Site staff will need to understand the privacy implications of the technology to be able to fully address any questions participants might have about data privacy.
Build diversity into the design process
If technology providers and sponsors wait until study recruitment begins to incorporate diversity into their clinical research technology, they are too late. Getting patient feedback on usability early in the design process is essential. They should also seek input during the design phase from diverse groups of sites on how they would deploy the technology locally, and how it would fit into their workflow to work well for their local population. Study sites can then be active partners at the forefront of deploying the technology and offering real-time feedback.
They should also consider participants’ and caregivers’ needs starting on day one of development. Caregivers are an important consideration as they play a critical role in helping many patients navigate their treatment journey. For a study involving children or adults who lack the mental capacity to complete study questionnaires or for a study where participants may have physical or sensory challenges, the caregiver is key to capturing accurate trial data. Technical considerations for a patient’s journey through a clinical trial may include:
- Building comfort and confidence with the technology
- Ensuring broadband access
- Adapting for sensory issues such as vision or hearing loss
- Compensating for physical limitations relating to fine motor skills
- Considering literacy in English or other languages
Testing and validation
During the COVID-19 pandemic, a subset of people was given supplemental oxygen too late.1 This tragic outcome resulted from the use of pulse oximeters that were developed without including a diverse range of skin tones. Technology developers should ensure that any wearable devices used in clinical trials are validated across diverse populations to avoid inherent biases in their measurements based on demographic differences, including race, ethnicity, skin tone, age, or other factors.
Study sites serve as on-the-ground hubs for deploying technology tools, whether they are disseminating wearable devices, guiding patients on the use of an app, or troubleshooting technical issues. These represent valuable opportunities to gather real-time feedback from a diverse participant population about their experiences with the technology. Sponsors should plan for a robust testing and validation phase for any new technology in collaboration with both sites and potential participants. It is key to have representative end users included as part of the technology product development and testing process.
Technical support
Developing a diverse clinical research environment may require flexible technical support options. To ease the burden on study sites and participants, sponsors should ensure that support is readily available or even built into the technology itself. This includes ongoing training, so staff are prepared as technology evolves.
Maximize flexibility
Study sites vary by size (large academic versus community settings), geographic region, language(s) spoken, and cultures. Flexible design allows sites to incorporate technology as it fits their diverse community.
Incorporating technology can potentially reach underserved and marginalized populations. The flexibility inherent in decentralized clinical trials can make participation more feasible for individuals otherwise limited by work commitments, family responsibilities, distance, accessibility, or cultural practices. However, care must be taken to ensure that the technology is accessible and does not inadvertently exclude those who may be less technology literate. Instructions should be simple and the technology intuitive and easy to use.
Reducing the need for in-person visits decreases logistical barriers to research participation. Technical solutions can be leveraged to add flexibility to study visits. For example, patients with chronic debilitating conditions who find travel challenging may benefit from wearable technology, which can monitor and record data in real-time from the comfort of their homes.
Adapt to meet the needs of complex study designs
Clinical research is becoming increasingly complex. How can technology be used to offset the increasing demands of complex study designs?
Start by laying out the participant pathway and schedule of events. Consider the complexity of the protocol and participant burden. Technology can then be deployed in a fit-for-purpose approach. Use technical solutions (including virtual visits, wearable technology, and artificial intelligence/machine learning) to decrease the burden on study staff of multiple data entries, and free up their time to focus on patient management and engagement. A fit-for-purpose approach for technology deployment allows participants to enroll who might not otherwise be able to join research studies and can accommodate patient preferences for on site or remote study visits.
Software interoperability
The phrase “less is more” applies here. Imagine being a study coordinator and having to remember 40 different logins and passwords at work! Today there is an increasing number of different point solutions. These systems may not be interoperable, resulting in reduced options, additional site training, and increased administrative burden.
Technology needs to be designed with interoperability in mind. This includes following global guidelines for harmonizing standards in algorithm development and adopting validation perspectives applicable to a diverse participant population. Technology developers should also consider solutions that work on existing platforms that sites and patients are already familiar with. The industry does not need more platforms and sponsors should allow those sites that have invested in technologies that are already embedded within their clinic workflow to leverage them and not force fit the study sponsor provided technologies for all sites.
Conclusion
With a prospective focus on diversity, technology can be molded and adapted to fit a plethora of needs. Incorporation of remote technology into clinical trials will allow research to be more accessible to diverse populations and can significantly expand their reach. If implemented thoughtfully, use of technology has the potential to make clinical research more representative and equitable.
About the authors
Ken McCann, DO, CIP, is board chair for UnityPoint Health in Des Moines, Iowa, and a community board member at WCG. Kelly FitzGerald is Executive IRB Chair and Vice President of IBC Affairs at WCG. Otis Johnson is the Co-founder & Principal Consultant at Trial Equity and the former Chief Diversity, Inclusion, and Sustainability Officer at Clario. Archana Sah is the Founder and CEO of AS Pharma Advisors and an industry thought leader and former pharma clinical development executive with a focus on oncology drug development and healthcare technology.
Reference
1. Fawzy A, Wu TD, Wang K, et al. Racial and Ethnic Discrepancy in Pulse Oximetry and Delayed Identification of Treatment Eligibility Among Patients With COVID-19. JAMA Intern Med. 2022;182(7):730–738. doi:10.1001/jamainternmed.2022.1906
