Drugs

Specs Guide on Submitting Drug Effects on Driving Trial Data

FDA has issued new technical specifications for submitting clinical trial data evaluating the effects of drugs and biologics on patients' ability to operate motor vehicles, including standardized datasets for assessing driving impairment.

The guidance, Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle, describes how sponsors should organize and submit driving assessment data to support drug and biologic marketing applications.

The recommendations primarily address studies of psychoactive drugs, although FDA said driving assessments may also be appropriate for certain non-psychoactive medications.

Such studies use specially instrumented vehicles or computer simulators to measure driving performance, including lane deviations, reaction times, lane departures and collisions. FDA said simulators may be preferable when a drug's safety risks make on-road testing inappropriate.

Driving studies typically use crossover designs comparing investigational drugs at one or more doses against placebo and a positive control. The timing of assessments depends on the drug's intended use.

The document provides detailed specifications for organizing clinical trial data using Clinical Data Interchange Standards Consortium (CDISC) standards, including the Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).

The recommendations address driving performance measurements, patient questionnaires, missing or incomplete observations, and the presentation of tables and figures used in FDA's application reviews.

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FDA Warns Baxter Over GMP Issues at Injectable Drug Plant

Senators Urge FDA to Crack Down on ‘Research Use Only’ Drugs

FDA Guidance on Drug-Related Software, Labeling Requirements

Device QMSR Fears Easing: Panel