A mechanism by which promising therapeutic agents are made available—early in their development without interfering with research—to patients ineligible to formally participate in clinical trials because of geographic or entry criteria.
In parallel tracking, the clinical trial proceeds on one track, while non-trial patients proceed on a separate/parallel track, from which various types of data can be obtained without interfering with the formal trial(s). Whilst treatment IND regulations focus on the early availability of experimental drugs to patients with life-threatening diseases, the parallel tracking plan–developed by the combined efforts of the FDA, NIAID, NAPO–National AIDS Program Office, and drug companies–is aimed at speeding clinical testing and marketing approval of potentially useful new drugs from the Clinical Trials Office of the NIAID, Rockville, Maryland. Parallel track protocols are developed along with the Phase II/III protocols to allow desperately ill patients with no other therapeutic options, access to the study drug through the sponsor, with less stringent data collection requirements.
References Science 1990; 250:1505n&v