The European Medicines Agency (EMA) and the European Society for Medical Oncology (ESMO) will host a workshop on single-arm trials (SATs) at the EMA headquarters in London, UK, on June 30th.
Single-arm trials are used when standard randomised trials are not possible, for example in rare cancers, where patient populations are very small. SATs have led to regulatory approval of oncology products showing dramatic activity in well-defined patient populations with high unmet medical needs. SATs, together with statistical approaches, could become the standard basis of evidence of efficacy for new applications. However, consensus is needed on what constitutes