30 January 2018 - The “Parallel regulatory-HTA scientific advice” procedure allows manufacturers to receive simultaneous feedback from both EU regulators and HTA bodies on development plans for new medicines.

The primary objective of the present study is to investigate whether parallel scientific advice (PSA) is integrated in the clinical development programmes for which advice was sought.

Contents of PSA provided by regulators and HTA bodies for each procedure between 2010 and 2015 were analysed. The development of all clinical studies for which PSA had been sought was tracked using three different databases. The rate of uptake of the advice provided by regulators and HTA bodies was assessed on two key variables: comparator/s and primary endpoint.

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