The Food and Drug Administration (FDA) advises sponsors of new drugs to classify human subjects on the basis of four specific demographic categories—age, race, sex, and weight. The FDA provides no advice for other possible categories, such as handedness. Sponsors' collection of data on race (a model requisite category) is seldom overridingly important, however, and sponsors' inattention to handedness (a model neglected category) can be very wasteful. For some drugs and some trials, an array of demographic characteristics other than those identified in the FDA Guideline should be analyzed.
Guideline for the Format and Content of the Clinical and Statistical Sections of New Drug Applications. U.S. Department of Health and Human Services, Public Health Administration, Food and Drug Administration, July, 1988.
2.
Physicians' Desk Reference (PDR) on CD-ROM. Release 3.0. Medical Economics Company, Inc., Oradell, NJ; May, 1991.
3.
WeissmanA.On the designation of race in clinical pharmacology reports. Drug Inform J.1989;23: 679–685.
4.
PolednakAP. Racial and Ethnic Differences in Disease. New York: Oxford University Press; 1989.
5.
CooperR.A note on the biological concept of race and its application in epidemiologic research. Amer Heart J.1985;108: 715–723.
6.
CorenS, ed. Left-Handedness: Behavioral Implications and Anomalies. Amsterdam: Elsevier; 1980.
7.
CorenSHalpernDF. Left-handedness: A marker for decreased survival fitness. Psychol Bull.1991;109: 90–106.
8.
LeidyLE. Early age at menopause among left-handed women. Obstet. Gynecol.1990;76: 1111–1114.
9.
HalpernDFCorenS.Handedness and life span. New Eng J. Med.1991;324: 998.
10.
PoracCCorenS.Lateral Preferences and Human Behavior. New York: Springer-Verlag; 1981.
11.
CorenS.Left-handedness and accident-related injury risk. Am J Publ Health.1989;79: 1040–1041.
12.
FincherJ.Sinister People. New York: Putnam; 1977.
13.
CorenSSearlemanA.Birth stress and left handedness: The rare trait marker model. In: CorenS, ed. Left-Handedness: Behavioral Implications and Anomalies. Amsterdam: Elsevier; 1990: 3–32.
14.
HarrisLJCarlsonDF. Pathological left-handedness: An analysis of theories and evidence. In: MolfeseDLSegalowitzSJ, eds. Brain Lateralization in Children: Developmental Implications. New York: Guilford Press; 1988: 289–372.
15.
BakanP.Nonright-handedness and the continuum of reproductive casualty. In: CorenS, ed. Left-Handedness: Behavioral Implications and Anomalies. Amsterdam: Elsevier; 1990: 33–74.
16.
SchwartzM.Left-handedness and prenatal complications. In: CorenS, ed. Left-Handedness: Behavioral Implications and Anomalies. Amsterdam: Elseiver; 1990: 75–97.
17.
AnnettM.Left, Right, Hand and Brain: The Right Shift Theory. Hillsdale, NJ: Erlbaum Associates; 1985.
18.
Flor-HenryP.Sinistrality and psychopathology. In: CorenS, ed. Left-Handedness: Behavioral Implications and Anomalies. Amsterdam: Elsevier; 1990: 415–440.
19.
GeschwindNGalaburdaAM. Cerebral Lateralization: Biological Mechanisms, Associations and PathologyCambridge MA: MIT Press; 1987.
20.
O'CallaghanMJTudehopeDIDugdaleAEHandedness in children with birthweights below 1000 g. Lancet1987;1: 1155.
21.
GeschwindNBehanP.Left-handedness: Association with immune disease, migraine, and developmental learning disorder. Proc Natl Acad Sci.1982;79: 5097–5100.
22.
HabibMTouzeFGalaburdaAM. Intrauterine factors in sinistrality: A review. In: CorenS, ed. Left-Handedness: Behavioral Implications and Anomalies. Amsterdam: Elsevier; 1990: 99–128.
23.
LondonWPAlbrechSA. Breast cancer and cerebral laterality. Percept Mot Skills.1991;72: 112–114.
24.
HsiehCCTrichopoulosD.Breast size, handedness and breast cancer risk. Eur J Cancer.1991;27: 131–135.
25.
FinkMIrwinP.CNS effects of the antihistamines diphenhydramine and terfenadine (RMI-9918). Pharmakopsychiat Neuropsychopharmakol.1979;12: 35–44.
26.
IrwinP.Greater brain response of left-handers to drugs. Neuropsychologia.1985;23: 61–67.
27.
IrwinP.Left-handers get higher than righties. Letter to the Editor of The New York Times, September 23, 1989.
28.
JosephAB. Non-right-handedness and maleness correlate with tardive dyskinesia among patients taking neuroleptics. Acta Psychiatr Scand.1990;81: 530–533.
29.
McCreadieRGCrorieJBarronETWinslowGS. The Nithsdale schizophrenia survey: III. Handedness and tardive dyskenesia. Br J Psychiatry.1982;140: 591–594.
30.
BarrWBMukherjeeSDegreefGAnomalous dominance and persistent tardive dyskinesia. Biol Psychiat.1989;25: 826–834.
31.
KernRSGreenMFSatzPWirshingWC. Pattern of manual dominance in patients with neuroleptic-induced movement disorders. Biol Psychiat.1991;30: 483–492.
32.
LondonWP. Left-handedness and alcoholism. In: CorenS, ed. Left-Handedness: Behavioral Implications and Anomalies. Amsterdam: Elsevier; 1990: 457–484.
CourseyRDBuchsbaumMSMurphyDL. Platelet MAO activity and evoked potentials in the identification of subjects biologically at risk for psychiatric disorders. Br J Psychiat.1979;134: 372–381.
46.
AmaducciLSorbiSAlbaneseAGainottiG.Choline acetyltransferase (ChAT) activity differs in right and left human temporal lobes. Neurology.1981;31: 799–805.
47.
OkeAKellerRMeffordILateralization of norepinephrine in human thalamus. Science.1978;200: 1411–1413.
48.
GeschwindN.Implications for evolution, genetics, and clinical syndromes. In: GlickS, ed. Cerebral Lateralization in Nonhuman Species.Orlando, FL: Academic Press; 247–278.
