Surrogate Markers Meeting, October 16-18, McLean, Virginia

Surrogate Markers & Clinical Outcomes of HIV: Strategies for
Selection and Use, a conference on the use of "surrogate
markers" such as viral load and CD4 counts in clinical trials
and perhaps in patient management, will be held October 16-
18, at the Ritz Carlton Tysons Corner hotel, in McLean,
Virginia. This meeting is organized by Cambridge Healthtech
Institute, which organized a similar meeting in October 1994.
Prices range from $395 to $895, plus hotel ($135 single or
double per night, if reserved before September 25).

"An analysis of currently available information surrounding
the selection, validation, and efficacy of HIV surrogate
markers and clinical outcomes will be the focus of Day One's
presentations. In this newly formatted open three-day forum,
the panel, consisting of the Executive Scientific Advisory
Committee members, will review the data and analyses
presented by prominent AIDS researchers and participate in
several open workshops focusing on novel investigations in
clinical research."

For more information, contact Cambridge Healthtech Institute,
617/630-1300.

Comment

This writer attended last years' meeting, and plans to go
again this year. We were disappointed in the outcome last
year, however, when a pre-appointed committee met privately
and wrote the recommendations of the meeting --
recommendations which later were widely ignored. This year it
appears that there will again be a pre-appointed committee,
only it will meet openly.

We were concerned that the recommendations were and may again
be too conservative, as committee products by their nature
are likely to be. We believe that the best way to save lives
is to move rapidly to use viral load and other tests of HIV
disease status as well as we can, for clinical management of
individual patients as well as for clinical trials to test
new drugs. But academic committees want to see data first.
People do not agree on what data should be required, however;
and some want data that will take a very long time to obtain.
The result is gridlock, with no company applying to the FDA
for approval of its viral load test, because no one has
decided what standards the tests must meet.

We believe that the key needs now are: (1) better information
on how best to use viral load clinically -- information which
we believe will develop much faster from clinical experience
in addition to trials, than from clinical trials alone; (2)
consensus on what standards must be met before viral load is
officially recommended for routine clinical use -- since
official approval would help greatly in lowering the price of
the test (by allowing routine use of test kits at reference
labs), and also in getting the cost of the test reimbursed
for patients; and (3) attention to developing immune-function
measures which are feasible for widespread clinical use --
especially immune function tests based on flow cytometry,
such as the new FastImmune* (CD69) system from Beckton
Dickinson. If this year's meeting can help with these issues,
it will make an important contribution.

In the future, more of this kind of work will be shifted to
computer conferences, where everyone can participate, at
little cost and on their own schedules. Face to face meetings
will always be necessary, but they will be better focused
when they do not have to cram everything into three pressure-
packed, expensive days.