Date: 20-Oct-2026
Intelligence Overview
The U.S. Food and Drug Administration (USFDA), through its Center for Drug Evaluation and Research (CDER), has issued the technical specifications document Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle: Guidance for Industry. The document provides recommendations for submitting clinical trial data from driving studies conducted to evaluate the effects of investigational drugs and biological products on a participant’s ability to operate a motor vehicle.
Driving studies are conducted primarily to assess the effects of psychoactive drugs on driving performance, although certain non-psychoactive drugs may also require such assessments. These studies may use computer-based driving simulators or specially instrumented on-road vehicles to collect objective performance measurements.
The technical specifications aim to standardize the structure and content of clinical trial datasets submitted to the FDA in support of drug and biological product marketing applications.
Key Highlights
1. Standardized Clinical Data Submissions
The document outlines specifications for clinical trial data prepared using the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).
2. Driving Assessment Datasets
The guidance describes the use of the SDTM Functional Tests (FT) dataset for driving assessment measurements and the ADaM Functional Tests Analysis Dataset (ADFT) for analysis-ready data. Examples of measurements include standard deviation of lateral position (SDLP), lane deviations, response time, and collision counts.
3. Handling Missing and Partial Data
The document provides recommendations for reporting missing assessments and assessments that end prematurely. Capturing the reasons for incomplete assessments is important for understanding safety and tolerability concerns that may influence the FDA’s benefit-risk assessment.
4. Measurement Tools and Supporting Information
The specifications address measurement tool identifiers, relationships between tools and study participants, tool properties and settings, and relevant events. They also cover supporting datasets, including comments, trial summaries, and questionnaire data.
5. Tables, Figures, and Supporting Documentation
The document includes specifications for tables and figures and emphasizes the importance of appropriate metadata and supporting documentation, including Define-XML, the Clinical Study Data Reviewer’s Guide (cSDRG), and the Analysis Data Reviewer’s Guide (ADRG), as applicable.
Regulatory Impact
The technical specifications provide sponsors and clinical data teams with a structured approach to preparing driving study data for regulatory submissions. Consistent data structures and transparent documentation can facilitate FDA review of driving performance, safety, tolerability, and relevant clinical outcomes.
Sponsors developing drugs that may affect driving ability should consider these specifications during clinical study planning, data collection, analysis, and submission preparation. Early consultation with the FDA is encouraged to clarify study endpoints, measurement tools, and the applicability of the recommended data displays to individual development programs.
Applicability and Important Considerations
The document focuses on clinical trial data supporting marketing applications for drugs and biological products. It does not establish requirements for FDA review of medical devices under the scope described in the document, nor does it address the validation or usability of measurement tools.
This technical specifications document represents the FDA’s current thinking and contains nonbinding recommendations. Sponsors should assess its applicability to their specific clinical development programs and consult the agency when clarification is needed.
Source: https://www.fda.gov/media/195806/download https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-clinical-trial-data-evaluate-ability-operate-motor-vehicle