Data monitoring and ethics committee (DMEC)

The DMEC is independent of the trial management group and oversees safety, efficacy and ethical issues, including any arising from new information from other sources. It normally confers about yearly, and can request any extra meetings or data analyses it considers appropriate. All investigators (other than the statistician and statistical consultant) remain blind to all the mortality data, but the DMEC reviews unblinded mortality data at each of its meetings. Its terms of reference are:

• Advise the trial management group on any ethical issues, and respond to any ethical concerns raised about (or by) AgeX. Such concerns should generally be communicated first to the trial coordinator, but can be sent directly to the DMEC chair.
• Advise the management group if, in DMEC’s opinion, there is proof beyond reasonable doubt* that an additional screening invitation at age 47-49 or at age 71-73 is definitely appropriate or definitely inappropriate for some or all identifiable categories of women.
• Communicate directly with the Director of Research Services of the University of Oxford (as study sponsor) if the DMEC considers any ethical issues not to have been resolved.

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* Appropriate criteria are not pre-specified, but as potentially relevant breast cancer and other deaths continue to accumulate for many years after entry to AgeX, a highly statistically significant difference in breast cancer mortality might well be required by the DMEC to justify release of mortality results earlier than scheduled.