What is a Neglected Population?
For our purposes, a ‘neglected population’ is ‘a population in whom there is insufficient evidence to inform the safe and effective use of medication’. Clinical trials often stipulate stringent eligibility criteria which are not reflective of the real-life clinical population who require treatment. Many clinical and demographic factors impact on disease burden and drug disposition, and whilst it is increasingly recognized that it is ethically imperative to study drugs in the populations in whom they are to be used, this is rarely the case in practice.14 An increasing body of work argues for and exemplifies the study of drugs in pregnant and lactating women and their infants, children and adolescents,15,16 but even in these there remains an unacceptable delay between the time of drug licensing and the availability of data to inform safe and effective use in such populations.17 Where intersecting characteristics exist that render an individual ‘complex’ - such as young, malnourished children with malaria or elderly individuals with prevalent co-morbid conditions - clinicians are forced to make a ‘best guess’ as to the appropriate drug treatment for that individual, perhaps leading to segments of the population that are thrice neglected (the next vanguard, once the twice neglected receive their fair due in research).