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Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

The first revision to the Guideline on strategies to identify and mitigate risks for first-in-human (FIH) and early clinical trials with investigational medicinal products from the European Medicine Agency (EMA) was released this past July. It comes after the death of a healthy study participant in a FIH study in 2016 and is the first revision of the Guideline since its release in 2007.

The focus of the Guideline is to establish the uncertainty and mitigate the risks in FIH clinical trials. The document discusses risk mitigation in quality aspects of clinical trial material, non-clinical and clinical testing strategies, study design and conduct of FIH clinical trials. However, despite the extra care taken in risk mitigation, the Guideline doesn’t eliminate the possibility of integrated and adapted designs if the risk profile suggests these strategies would be safe.

At Altasciences, we are accustomed to documenting thorough risk assessments for FIH trials and adding risk mitigation strategies to the studies we run. The new EMA Guideline will help us maintain our focus on risk assessment and ensure we can still complete FIH studies in the safest but most time-efficient way.

 

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Impaired driving performance and cognitive functions

Since 2013, there has been a noticeable increase in the information provided by the Food and Drug Administration (FDA) on the effects of prescription and over-the-counter medication on driving. Consequently, the FDA demands that certain drugs be tested for impaired effects.

At Altasciences, we conduct these specialized studies with the use of a state-of-art driving simulator to assess a wide range of psychomotor and neurocognitive effects.

Our latest article published in the Journal of Human Psychopharmacology on the Next-day residual effects of Flibanserin on simulated driving performance in premenopausal women, co-authored by our Clinical Principal Investigator, Dr. Éric Sicard, provides great insight on the importance and conduct of driving studies.

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