Phase III SELECT MDS-1 Trial Clause Samples
The 'Phase III SELECT MDS-1 Trial' clause defines the specific clinical trial referenced in the agreement, typically identifying it as a late-stage, large-scale study evaluating the safety and efficacy of a particular investigational product in patients with myelodysplastic syndromes (MDS). This clause usually outlines the trial's official name, protocol number, and may specify the trial's objectives, endpoints, or regulatory context. By clearly identifying the trial, the clause ensures that all parties understand which study is being discussed, thereby preventing ambiguity and aligning expectations regarding obligations, data sharing, or results reporting related to this specific clinical trial.
Phase III SELECT MDS-1 Trial. The Phase III SELECT MDS-1 Trial (a) fails to achieve statistical significance on the primary endpoint of complete response (detecting a difference in the complete response rates between the tamibarotene plus azacitidine treatment group and the placebo plus azacitidine treatment group, with an assumed 2:1 randomization between these treatment groups, and a one-sided alpha of 0.025) or (b) is terminated for safety reasons; or”
2.13 Section 8.15 (