Important Details about the FDA Guidance

The guidance detailing the FDA’s current thinking and expectations around how and when to assess a new drug’s ability to affect driving was released in November 2017.

Entitled Evaluating Drug Effects on the Ability to Operate a Motor Vehicle, the guidance proposes a tiered approach to evaluating possible drug effects on driving which, if adopted, will be a dramatic shift in design for early phase studies.

Dr. Gary Kay, President of Cognitive Research Corporation (CRC), whose work has contributed in a considerable way to this guidance, is both cited within the guidance for his work with the National Highway Traffic Safety Administration, and was also part of the expert panel brought together by the Center for Drug Evaluation and Research (CDER) during the guidance’s development, providing industry expertise around driving simulation and cognition.

"What the FDA has made clear in this guidance is that researchers can no longer rely solely on the self-reported or staff observed adverse effects which are routinely collected in all trials, and that an individual’s ability to self-assess their driving and cognitive functioning is often inadequate", indicates Dr. Kay.

Evaluating Drug Effects on the Ability to Operate a Motor Vehicle - Guidance for Industry

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Ingrid Holmes, Vice President, Clinical Operations, explains what this means for sponsors:
"The FDA has defined a clear path forward for all new drugs, not just those intended for central nervous system (CNS) indications. It is clear that all new drugs should be evaluated for adverse effects on the CNS during first-in-human studies, which is a dramatic change from how most trials are standardly designed today. The ability of Algorithme Pharma to conduct these specialized tests, combined with the highly recognized battery of psychomotor and neurocognitive tests offered by CRC, will allow us to seamlessly incorporate these elements into our trials."

"We expect that, if required, most driving studies will be conducted at the phase IIb stage of drug development, generally after a therapeutic dose has been chosen and adequately studied. The trials CRC designs for both driving assessments and cognitive function are already entirely compliant with this guidance. Running a large driving study with the joint efforts of CRC and Algorithme Pharma will save sponsors about half the time and budget than doing a European over-the-road driving study." adds Dr. Kay.

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