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Conditional (European Medicines Agency) or accelerated (U.S. Food and DrugAdministration) approval of drugs allow earlier access to promising newtreatments that address unmet medical needs. Certain post-marketingrequirements must typically be met in order to obtain full approval, such asconducting a new post-market clinical trial. We study the applicability of therecently developed harmonic mean Chi-squared test to this conditional oraccelerated approval framework. The proposed approach can be used both tosupport the design of the post-market trial and the analysis of the combinedevidence provided by both trials. Other methods considered are the two-trialsrule, Fisher's criterion and Stouffer's method. In contrast to some of thetraditional methods, the harmonic mean Chi-squared test always requires apost-market clinical trial. If the p-value from the pre-market clinical trialis << 0.025, a smaller sample size for the post-market clinical trial is neededthan with the two-trials rule. For illustration, we apply the harmonic meanChi-squared test to a drug which received conditional (and later full) marketlicensing by the EMA. A simulation study is conducted to study the operatingcharacteristics of the harmonic mean Chi-squared test and two-trials rule inmore detail. We finally investigate the applicability of these two methods tocompute the power at interim of an ongoing post-market trial. These results areexpected to aid in the design and assessment of the required post-marketstudies in terms of the level of evidence required for full approval.

Combining Evidence from Clinical Trials in Conditional or Accelerated Approval