Without an effective strategy, regulation affecting diversity enrollment might impact the ability of sponsors and sites to carry out any research at all, according to conversations with industry research professionals.
Among other data management advice for trials, experts say that clinicians and researchers should consider patient convenience and inconvenience when deciding on the most appropriate data to be recorded.
Decentralized clinical trials pose unique challenges because the critical elements of the trial, from administering treatment to recording and verifying data, no longer take place under the watchful eye of the investigator.
Considering the importance of how not to lose track of how real people fit into where the clinical research enterprise is headed with its current deep dive into big data, artificial intelligence, and other tech-driven trends.
Results of clinical trials are only as good as the data upon which they rest. This is especially true in terms of diversity—if most people in a trial are from a certain race or socioeconomic group, then the results may not be broadly applicable. This form of potential bias is not a novel concept, but a group of researchers at the University of Illinois Chicago that includes an ACRP Student member as well as colleagues from other institutions has identified a potential hidden source of bias: electronic health records.