Clear Rules Needed For Disclosing Clinical Trial Estimands
Although estimands are a great tool for clarifying the treatment effects that are being investigated in a clinical trial, existing registries are not well suited for their public disclosure. Industry-wide guidance can help sponsors using different approaches.
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A globally harmonized template for clinical trial protocols would help sponsors develop protocols that are “well organized” and “free from ambiguity,” according to the International Council for Harmonisation.
Drug companies are complying with their obligation to submit clinical trial results to the US-based ClinicalTrials.gov database, but major errors in their submissions prevent the results from being uploaded in a timely manner.
An addendum to the International Council for Harmonisation's guideline on statistical principles for clinical trials proposes a new framework on how the concept of estimands can be used to help clearly describe the effects of a medicine.