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.
While many sites have not yet transitioned away from the traditional paper-based source model for data, electronic source may represent an efficient systematic alternative to this traditional method.