15 citations · 63 across the 20 of their papers we have counts for
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Beyond the Two-Trials Rule
Leonhard Held
The two-trials rule for drug approval requires "at least two adequate and well-controlled studies, each convincing on its own, to establish effectiveness". This is usually implemen…
Replication of "null results" -- Absence of evidence or evidence of absence?
Samuel Pawel, Rachel Heyard, Charlotte Micheloud +1
In several large-scale replication projects, statistically non-significant results in both the original and the replication study have been interpreted as a "replication success".…
Simulating and reporting frequentist operating characteristics of clinical trials that borrow external information
Annette Kopp-Schneider, Manuel Wiesenfarth, Leonhard Held +1
Borrowing of information from historical or external data to inform inference in a current trial is an expanding field in the era of precision medicine, where trials are often perf…