At FHI Clinical, our mission is to achieve maximum social impact through the support and development of life-saving vaccines and medicines — for everyone. Key to this is equitable and representative access to clinical research, something we have discussed in previous blog posts and articles.
Including participants representative of the population who will benefit most from a vaccine or drug helps ensure safety and efficacy for everyone as well as opportunities to benefit from the care provided during clinical research. Moreover, regulatory agencies such as the U.S. Food & Drug Administration (FDA) are placing greater emphasis on ensuring diverse clinical study enrollment with the aim of reaching a representative population.
Although the life sciences industry has made some progress in this area, barriers to equitable research access still exist. These barriers include limited research capacity in hard-to-reach locations, a lack of cultural awareness and low levels of engaging the community. In addition, features in eClinical tools such as clinical trial management systems (CTMS) and how study teams use those features can impact visibility into whether the appropriate level of representativeness is being achieved throughout the study.
Visibility into study progress and participant enrollment helps achieve representation
Meeting enrollment goals throughout the study is critical to meeting timelines and budget. For this reason, effective ways to monitor planned versus actual enrollment are important for study teams. When poorly performing sites or regions are identified, site training, contingency plans and renewed recruitment efforts can be implemented to mitigate these risks and get the study back on track.
For the purposes of reaching inclusion and equity in research, who is being enrolled is as important as how many people are being enrolled. This is where studies, and even healthcare organizations, often fall short. Of more than 20,000 U.S.-based trials in clinicaltrials.gov (in the years 2000-2020), only 43% reported any race/ethnicity data, and socioeconomic status (SES) was reported in <15% of studies. Healthcare organizations similarly fail to record race/ethnicity and sexual orientation (SO)/gender identity (GI) data for their patients.
Sociodemographic characteristics that can affect health outcomes
- Race/ethnicity
- Age
- Biological sex, sexual orientation and gender identity
- Educational and employment status
- Socioeconomic status
- Geographic location/access to healthcare
- Geographic location/environmental conditions (e.g., neighborhood segregation)
- Genetic variation/geographic ancestry
Whether sociodemographic data are collected but not reported or just not collected is not clear. Healthcare organizations often simply do not record the information for their patients for a variety of reasons, including hesitance from both the provider and patient to discuss potentially sensitive subjects. The same could be true in many clinical research studies.
In clinical research, with the increasing importance of including diverse populations, recording, monitoring and reporting sociodemographic information are critical to advancing science as well as equitable access to research.
CTMS features that improve visibility across studies and programs
A CTMS, as the primary study project management tool, helps effectively plan, manage and track individual studies as well as entire development portfolios. Metrics being tracked include participant recruitment and enrollment. Although many CTMSs support recording and storing broad sociodemographic information for study participants, they are often not used to their full potential for this purpose. Study teams also need access to robust dashboards to quickly identify if participant representativeness is being met.
- Cloud-based storage and access for localized study team members in global clinical trials to collaborate and ensure all locations are contributing to the overall study goals
- Data aggregation and comparison across multiple studies and regions
- Access to historical data — to inform future decisions
- Standard and custom dashboards that enable quick viewing of participant characteristics and comparison to plan
- Easy integration with other systems, such as electronic data capture (EDC)
- Fields and forms that can be designed to meet specific protocol needs
- Adaptability to changing study recruitment needs
- Hands-on system training for CRAs to ensure the system’s features are being used to their fullest
- Strong customer service relationships to enable rapid adjustments to reporting, as needed
A CTMS with these capabilities enables data sharing for dispersed team members. Study teams can review sociodemographic characteristics of currently enrolled participants to inform whether different recruitment tactics need to be adopted — for example, they could choose to do more community outreach or open a site in a different geographic area.
According to Michelle Stanek, Associate Director, Clinical Operations, FHI Clinical, “The ability to be cloud-based provides greater ability for our teams worldwide to work together. Our team can work with sites to get data reported quickly and then provide rapid feedback to our clients. Because changes are made in near real time, we’re able to stay on top of recruitment and enrollment globally.”
Reporting of sociodemographic characteristics enabled by EDC systems
Seamless integrations between CTMS and EDC systems help with the reporting of collected sociodemographic information. As the primary system for collecting (either directly or through integrations with other systems, wearables and devices), storing and analyzing the data collected from participants in clinical research, EDCs are an important source of participants’ sociodemographic characteristics. Not only can the EDC provide that data to the CTMS but the EDC can also facilitate robust analyses of data by sociodemographic subgroups.
To avoid manual re-entry of data in multiple systems (i.e., CTMS and EDC), systems should seamlessly integrate for easy transfer of data. This is especially important to enable real-time monitoring of the characteristics of enrolled participants.
Regarding data analyses, reporting sociodemographic information in publications and performing analysis in aggregate and by sociodemographic subgroups helps with the understanding of the impact of these differences – for future clinical trials as well as for clinical practice.
How Oracle Clinical One provides greater visibility into enrollment trends
We believe in strong partnerships with service and software providers who complement our experience with their specific expertise. Our collaboration with Oracle has enabled us to provide quality data and clinical management tools to our stakeholders and sponsors.
Regarding visibility, Michele Fanton, Data Project Manager, described, “[Oracle] Clinical One offers dashboards that give our employees and sponsors full visibility into combined data from various studies.” She added, “I also use the database to look for outlying issues, so we can see past issues with a site and can make higher quality recommendations should that site be included in a future study.”
The FHI Clinical team has found the ability of Oracle Clinical One to efficiently pull data into monitoring visit reports (MVRs) helpful to keep us and our sponsors informed on site-specific participant recruitment issues or deviations from the protocol. They can then determine if participants must be replaced or if enrollment at certain sites should be slowed or halted or, conversely, if additional participants can or should be enrolled at a site.
The software also includes a training platform in which all employees can participate, regardless of geographic location. “The employees using the system have diverse backgrounds when they come into the training environment. For example, our CRAs in the U.S., South Africa and Vietnam all have direct interaction with each other and can share opportunities for improvement,” said Stanek.
Additionally, Oracle Clinical One is adaptable to study protocol needs. Fanton spoke of her experience working with the Oracle team on a particular study: “We’ve appreciated Oracle’s collaborative approach. Our service and subject matter expert partners at Oracle have provided mentoring and demonstrated how to build a database for a unique protocol. We’ve found Clinical One to be highly configurable, more so than other systems.”
Stanek added, “Oracle Clinical One Data Collection and CTMS, when used to their fullest potential together, will improve overall study efficiency, which will allow for less expensive and potentially faster analysis of trial data, thus getting the product to those who need it most — faster.”
Partnerships for collaboration and to facilitate change management
Using eClinical software and sociodemographic data in the manner described here may require some level of organizational change management and creation of standard operating procedures (SOPs). Partnering with an experienced contract research organization (CRO) with experience enrolling representative populations can streamline this process. Contact our team to discuss how our established SOPs, global team and collaboration with Oracle could benefit the representativeness of your next study.
