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Bob Huff

Members of a DSMB are as prone to fear or elation as any other group of people facing the unknown who are tasked with making decisions that affect people's lives.

Perhaps one of them read this note on your initial blog entry on the STEP trial halt: "...there is some basic immunology data which might suggest that there is a period immediately after immunization when activation of CD4 T cells could enhance susceptibility to HIV infection, before their differentiation into memory CD4 T cells is completed..."

Members of the Phambili DSMB may have become convinced that the ethical and responsible thing was to inform participants about the possibility of enhancement--theoretical as it may be; a p-value ~ 0.1 is nothing to sniff at even if it has not reached significance... particularly if you have the weight of the world on your shoulders and you start to believe that things may be going horribly wrong.

As Paul Meier, one of the many generous biostatistician mentors to AIDS activists in the early '90s used to say: "You've got to have nerves of steel to serve on a DSMB."

Richard Jefferys

Agreed, it was unfair and inappropriate to call into question the judgment of the Phambili DSMB in the prior post. I can only wish someone had been able to provide an explanation of why there were differences between the Phambili and STEP DSMB's responses.

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