We know that clinical research changes are slow since it’s based on practices that require large, established data taxonomies. But at CRIO, we encourage pharma companies to adopt more gender-inclusive language. For example, some protocols may require only people assigned to one or the other sex at birth and if so, they should clearly state that.
Others do not have this restriction, and simply state the inclusion criterion as “males or females 18 and over.” In this case, the protocols should have taxonomies and/or guidelines that specify how investigators should classify individuals who identify with a gender different from the sex assigned at birth. Lack of inclusive language creates unnecessary ambiguity and leads to datasets that are misaligned with datasets collected in the healthcare world, as most EHR systems are now adopting gender inclusivity.
Historically, CRIO had a “Gender” field in our patient database that had only two choices – Male or Female. We renamed the field to “Sex” and expanded the choices to include “Intersex” and “Unknown.” Patients classified as male or female retain that classification in the new Sex field.
We then added a separate “Gender Identity” field, which can be populated going forward by our clients. Using this combination, users can now identify transgender or non-binary individuals. For example, a transgender woman could be categorized as Male for Sex and Female for Gender Identity. Similarly, a non-binary, biological male individual could be represented as Male for Sex and Non-Binary for Gender Identity.
The pharma industry is slowly moving in this direction. We reviewed 40 recent study protocols and of these, 10% had gender-inclusive definitions, while the rest simply offered a binary choice of gender without any explanation or definition.
Our enhancement ensures that our clients can respect their patients’ identities while aligning data collection with these evolving standards. As always, CRIO clients can further tailor sex, gender, or any other demographic field at the study level through our flexible eSource configuration. We believe that transparency is important for building trust and credibility. While clinical trials may still have a lot of work to do in boosting diversity and inclusion, CRIO is committed to advancing research around the globe and changing how the world experiences clinical trials.
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