Is The BMIS Dataset Flawed For This Use?
Source: Clinical Leader
The BMIS dataset, which tracks FDA Form 1572 submissions, is incomplete and voluntary, making it difficult to assess the true number of "one and done" PIs. Paul Ivsin of Continuum Clinical also discusses how past surveys found that many listed as one-time participants actually completed multiple trials, raising doubts about using the Form 1572 metric to measure retention of PIs.
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