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).