AIDS TREATMENT NEWS #220, April 7, 1995
The last issue of AIDS TREATMENT NEWS included information on
enrolling in ICC 001, the first study of the Inter-Company
Collaboration for AIDS Drug Development, a consortium of 15
major pharmaceutical companies. However, there is a potential
problem in the enrollment process that we did not know about
when that issue went to press.
Before patients will be screened for this trial, they must
bring in blood work showing that they will probably pass the
screening. According to the ICC protocol, this blood work must
be within 30 days, and must include specified lymphocyte
subsets, hematology testing, and serum chemistry. Since most
people get their blood work done every three to six months,
this can create scheduling problems. Check with the site about
exactly what the requirements are.
$150 per patient has been budgeted for miscellaneous expenses
in the trial; sometimes it can be used if the patient's
insurance will not cover the required tests.
We have never heard of this pre-screening requirement before.
It raises two concerns:
(1) The 30-day limit will delay enrollment by up to several
months, further slowing a study which has already had major
(2) This is a new example of medical cost shifting. The usual
result is to shift the burden of treatment and of research
onto the party least able to pay -- the individual already
facing the stress of major illness -- because the
institutions which could easily pay can avoid the cost.
In this case, the additional cost of the usual flexibility --
taking whatever blood work is available, and accepting the risk
of more unsuccessful screenings -- would probably average well
under $100 per patient, or well under $22,500 for all the
patients in the trial -- a small amount of money compared to
the costs of doing clinical research.