Efficacy gap between phase II and subsequent phase III studies in oncology.
Rick A VremanSvetlana V BelitserAna T M MotaAnke M HövelsWim G GoettschKit C B RoesHubert G M LeufkensAukje K Mantel-TeeuwissePublished in: British journal of clinical pharmacology (2020)
The lack of marked average differences between phases may encourage decision-makers to regard the quality of design and total body of evidence instead of differentiating between phases of clinical development. The large variability emphasizes that replication of study findings remains essential to confirm efficacy of oncology drugs and discern variables associated with demonstrated effects.