The AHCC06 trial had its scheduled first Interim Analysis on 22 May 2013 and we are pleased to share that the Data Safety and Monitoring Board (DSMB) found the trial to be on track with no safety issues. A DSMB is an independent group of experts who monitor safety of patients and treatment efficacy data while a clinical trial is ongoing.
The board comprised of Dr Thomas Leung (Chairman), Prof David Machin and Prof Bruno Sangro. The DSMB met in Singapore, with Prof Bruno participating via videoconferencing. The DSMB found the overall conduct of the trial to be good and recommended that the trial to continue in its present form.
It is an important milestone for the trial. The positive Interim Analysis report is a validation of the capability of the team and an affirmation of the study team’s management of multi-centre trials.
Media Release, July 2, 2013
Interim analysis found SGH-led SIRveNIB regional phase III clinical trial to treat patients with locally advanced liver cancer right on track. Click here to see the media release on the SGH website (www.sgh.com.sg).
|Ms Sandra Hsing (CRA), Ms Janice Ng (CRA), Dr Mihir Gandhi (Trial Statistician), Prof Pierce Chow (Protocol Chair), Prof Machin (DSMB Member), Prof Sangro (DSMB Member), Dr Leung (DSMB Chair), Ms Sophie Moss (Project Manager) and Mr Xia Yu (CRA) at the meeting.