adverse event reporting

[Guest guest]

On 13 Feb 2005 16:21:50 -0000 > I'm

also wondering how adverse reactions are reported. Seems its entirely

> left up to [only] M.D. 's

>

>

Ed,

Insofaras federally funded and FDA funded research, researchers are

obligated to report adverse events (AEs) through the auspices of their

institutional review board (IRB). In institutions like Kaiser or any

university, the IRB is the local authority charged with implementing

federal regulations concerning the protection of human research

participants. They spend alot of time reviewing consent forms for

example, as well as research protocols, and they " process " AEs as well,

albeit in my personal opinion rather rubber-stampedly. An IRB can,

however, shut down research by committee quorum. Researchers take their

reporting responsibilities very seriously because they don't want to lose

their appointment or their funding.

 

Upstream from the IRB, though, is the DSMB - the data safety monitoring

board. The DSMB is a an expert committee, independent from the

investigators and (supposedly) the sponsor of the trial, which

periodically examines the safety data accumulated during the trial and

ensures that the benefit/risk ratio remains acceptable for participating

patients. The DSMB is also a safeguard for the scientific integrity of

the trial. It is the only committee which can have access to unblinded

data from the trial. The DSMB can shut down trials. The DSMBs view

themself as protecting participants and ensuring the integrity of the

study. The DSMB should operate under a clear expectations understood by

all members of the Board, the sponsor, and the investigators. Sponsors

must trust their DSMBs. The sponsor must give the DSMB the tools and the

data that it needs to operate effectively in protecting the safety of the

participants.

Data and safety monitoring requires organization with regard to schedules

for data collection, active surveillance for adverse events, with special

emphasis on serious or unexpected events, and the ability to bring all

information within a study and newly accruing information external to the

research project together as needed for assessment of patient safety.

 

However, the reason I took pen to paper is to make the point that there

is a HUGE difference between a DSMB organized under federally funded

research and a DSMB organized under an FDA-regulated industry trial. The

former has far more authority and independence. The latter reports to

the sponsor. This is what we saw with Vioxx. As I said, supposedly the

DSMB is independant but we saw the heinous breakdown of this ideal with Vioxx.