Obstacles to Drug Development for HIV-Related Opportunistic Infections

15

tients.74 Several ACTUs had enrolled fewer than 20 persons in OI
trials at all levels of priority.75
In April 1989, NIAID staff wrote to the ACTG Opportunistic Infection Committee Chair, referring to the lack of OI research in the
ACTG, "I agree with you that mere discussion of these problems is
no longer adequate and some concrete decisions and steps must be
taken to clarify and resolve the situation." The letter furnished evidence that for well over a year NIAID staff and ACTG leadership
had been discussing the need for broader participation in OI studies by the ACTG and that incentives for participation in the more
complex and costly protocols be developed.76
The Opportunistic Infection Committee of the ACTG recommended that a goal be established for the percentage of patients in OI
trials, and a commitment made to meeting that goal. The OI Committee recommended that 30 to 40 percent of the total number of
patients in the ACTG be enrolled in OI studies.77 Based on the estimated number of enrollees, the ACTG can then determine how
many ACTU's must participate in each OI study. The OI Committee believes all ACTU's should participate in OI studies because OI
patients are seen and cared for at all centers. At the time of the
hearing, only 23 of the 32 adult ACTUs had participated in acute
01 studies. Ideally, each ACTU should be able to conduct investigations of many different types of therapies for persons along the
entire spectrum of HIV disease, from asymptomatic to seriously ill
hospitalized patients with end-stage disease and multiple OIs.78
Since infection with Pneumocystis is ubiquitous at present, all
ACTU's should be able to participate in studies of PCP treatments.79
The complexities in managing OI protocols should be recognized
and funding adequate to cover the additional expense incurred be
made available to the ACTU's. There should be incentives offered
to ACTU's that undertake difficult studies in the form of credit in
proportion to complexity and cost.8~
Better participation in clinical trials can only be achieved
through new NIAID policies and procedures that provide incentives
to ACTU's for their full cooperation with OI studies. These include
recognition of the complexity of OI studies; extra funding or credit
in proportion to complexity and cost; and recognition of success in
implementing and completing OI protocols.s 1
Assistance from NIAID is recommended to help ACTUs with
practical problems with OI studies such as recruitment of patients.
Materials from the NIAID program staff, direct advice and assistance from program staff or from other ACTUs that have overcome
similar obstacles.82
74 Op. cit., see footnote 70.
75 See footnote 70.
76 Hearing, p. 248, letter to Dr. John Mills, Chief, Division of Infectious Diseases, San Francisco General Hospital from Dr. Maureen W. Myers, Chief, Treatment Research Branch, AIDS Program, NIAID, April 17, 1989.
77 Op. cit., see footnote 68.
78 Ibid.
79 Hearing, Dr. Sattler, p. 193.
so Op. cit., see footnote 68.
8 1 Ibid., p. 193.
82 Hearing, Dr. Sattler, p. 194.