Last year Sunesis completed the VALOR trial, the first clinical study to make use of the groundbreaking promising zone design. The promising zone design implements an unblinded sample re-estimation after an interim look, but only if conditional power during the interim look falls within a designated promising zone. Although the VALOR trial did not confirm the efficacy of the new therapeutic, it provided the drug with the best possible chance to prove its efficacy.
The video below shows Jennifer Smith, the Executive Director of Biometrics at Sunesis, and Cytel President Cyrus Mehta, discuss the Statistical and Operational Challenges of the VALOR trial. Smith and Mehta spoke as a part of the Cytel and ASA sponsored event Statistical Innovations in Clinical Development.