He said the tenets of evidence-based medicine mandated that medicines should be tested and shown to be safe and effective before licensing for use.

Prof. Adjei said this at an inaugural lecture in Accra on the topic, "Enigmas in Clinical Trials in Ghanaian Children." The lecture organised by the University of Ghana.
He said evidence showed that many medicines used in children were prescribed outside the terms of their product license, even though the licensed medicines had undergone evaluation processes.

The phenomenon, he stressed, referred to as "off-label drug use," of which among children it was often based on extrapolation in the absence of firm evidence.
He said medicines that had been tested in and found to be safe and effective in adults but not tested prior to use in children would not be supported by the same level of high-quality evidence.

That, he said, had the potential to perpetuate an anecdotal belief system and risk a false sense of assurance that did not encourage further rigorous testing.
He said while it was legal and an acceptable practice, especially in situations when alternative treatments dd not exist, it bypassed the safeguards of modern drug regulation and had been linked to an increased risk of adverse effects.

Prof. Adjei said the relative absence of information on medicines for children was an unintended outcome of legislation enacted in response to disasters that occurred in the last century.
Legislations like the Pure Food and Drug Act, 1906; Food, Drug, and Cosmetic Act, 1938; and others are said to have promoted the exclusion of children from trials of new medicines.

The Professor called for clinical research and training on important methodologies that would be situated in culturally relevant circumstances with the appropriate messaging.

He called for the establishment of a child health research institute and put in place approaches that optimised the health outcomes of children.

Prof. Adjei said incentives and barriers to paediatric drug research should be under strict supervision and safequards.