Trial Quality Data Standards Needed to Improve Oversight Methods, Experts Say
Clinical trial oversight can be improved at scale if the industry moves to develop and share data on trial errors and publish details on trial quality, experts say.
Penelope Manasco, CEO of MANA RBM, a risk-based monitoring solution provider, and Deepak Bhatt, a professor of medicine at Harvard Medical School, said sponsors, academic institutions and journals should develop and provide reference datasets with defined errors for trials, similar to reference standards for analytic tests. This approach would allow comparison of different oversight methods’ effectiveness, they contended in an article recently published in Contemporary Clinical Trials.
In addition, systematically testing different trial monitoring methods using these reference datasets would help researchers and sponsors better understand, select and refine trial monitoring methods, including source data verification, potentially saving resources and helping ensure participant safety, the article said.
The authors also recommended trial publications include details on the quality of the trial, including the number of major deviations — errors in informed consent, measurement of primary endpoints and participant enrollment — to improve research quality assessments.
Read the article here: https://bit.ly/37Pnxkd.