Parallel track policy

Parallel Track is another mechanism that permits dispensing investigational drugs, particularly to AIDS patients that do not qualify to participate in controlled clinical trials of promising drug candidates. The parallel track policy was developed by the US Public Health Service in response to the AIDS epidemic. Federal Register of 21 May 1990)... 

Very ill patients may receive a drug that shows promise in late clinical trials. This requires the IND to be classified as a treatment IND. Treatment IND status is valuable for critically ill patients who may not be able to wait until the drug receives full NDA approval. Related to a treatment IND is the parallel track policy. Specifically developed to help AIDS patients, INDs with parallel track classification may be administered to patients who are not healthy enough to qualify for inclusion in a phase trial. Data from parallel track patients are not included in the clinical trial data. 

Another mechanism used to permit wider availability of experimental agents is the "parallel track" policy (Federal Register of May 21, 1990) developed by the U.S. Public Health Service in response to AIDS. Under this policy, patients with AIDS whose condition prevents them from participating in controlled clinical trials can receive investigational drugs shown in preliminary studies to be promising. 

Parallel track drug policy, 18 689 Paramagnetic defects, in vitreous silica, 22 410... 

Parallel Track Mechanism A U.S. Public Health Service policy that makes promising investigational drugs for AIDS and other HIV-related diseases more widely available under parallel track protocols while the controlled clinical trials essential to establish the safety and effectiveness of new drugs are carried out. The system established by this policy is designed to make drugs more widely available to patients with these illnesses who have no therapeutic alternatives and who cannot participate in the controlled clinical trials. 

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