"Parallel Track: Where Should It Intersect Science?"

Important note: Information in this article was accurate in 1990. The state of the art may have changed since the publication date.

"Parallel Track: Where Should It Intersect Science?"

Science (12/14/90) Vol. 250, No. 4987, P. 1505
Skerrett, P.J.

Abstract: At the "Expedited Access to Unproven Pharmaceuticals: Risk, Regulation, and Personal Autonomy" conference last month, activists and researchers sharply debated the "parallel track" and how much or how little data should be collected under a system designed to make promising therapies available to terminally ill people. The parallel track itself has not yet been formally instituted--the closest thing to it is the expanded access program for ddI, through which almost 14,000 people have gotten the drug. Activists say the amount of paperwork required by data collection in the ddI trials has overwhelmed doctors, and that little data should be gathered in a program aimed at treatment and not research. Researchers say such large-scale patient usage demands at least some simple data on safety and efficacy. The solution may be a proposed third track of huge trials open to everyone, designed to answer straightforward safety and efficacy questions, as in the Community-Based Clinical Trials Network's upcoming trials of pyrimethamine for toxoplasmosis.

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