The Trial That Changed Practice: No Town-Seated Investigator; Two Boundary Pattern Trials

Item 8 · Town test + boundary (Notre Dame / South Bend)

Lead: The town test came first: searches of the trial and journal literature for an investigator seated in New Carlisle, Indiana — by place name and by ZIP — returned no town-seated trial investigator and no trial run from here. The loudest noise in that search is a namesake, the British anaesthetist John Carlisle, whose trial-data work is not this town and is discarded by reading. The two pattern trials the checklist names are therefore carried at boundary size, as Notre Dame / South Bend work. First: Rudolph M. Navari — named in Notre Dame's 2007 record as assistant dean and director of IUSM—South Bend — led the phase 3 trial of olanzapine for chemotherapy-induced nausea and vomiting, published in the New England Journal of Medicine on 14 July 2016: 380 evaluable, chemotherapy-naïve patients on highly emetogenic regimens, with no nausea in the first 24 hours in 74% on olanzapine against 45% on placebo, and complete response 64% against 41% over 120 hours — a result that changed antiemetic practice, from a multicentre NCORP trial, not a New Carlisle trial. Second: the AEGIS spatial-repellent project in Kenya, led by the University of Notre Dame with Nicole Achee as lead principal investigator, published in The Lancet and credited by Notre Dame, Unitaid, and the WHO's own announcement chain with informing the WHO's conditional recommendation for spatial emanators in malaria control in August 2025 — first-time malaria infections one-third lower with bed nets plus spatial repellents than with bed nets plus placebo. Both trials matter to medicine; neither was seated here, and this section does not move them.

Sources:

1. Navari RM et al., “Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting,” N Engl J Med 375:134–142, 14 July 2016 (PMID 27410922; NCT02116530): 380 evaluable patients; nausea and complete-response figures as quoted.
2. Notre Dame news, 26 June 2007 (Harper Hall gift): Dr. Rudy Navari named as assistant dean and director of IUSM—South Bend.
3. Notre Dame / Eck Institute news, 30 Sept. 2025, and Unitaid announcement, 13 Aug. 2025: WHO conditional recommendation for spatial repellents; AEGIS Kenya trial led by Notre Dame, lead PI Nicole Achee; Lancet findings; one-third reduction in first-time infections.
4. Town test: literature searches for “New Carlisle, IN” / 46552 as a trial site or investigator affiliation — no town-seated investigator found; surname-only “Carlisle” hits excluded by reading.