Correspondence
and Drug Administration 4 has 2 Ower AK, Hadjichrysanthou C, Gras L, et al.
released a guideline for industry for
the development of treatments for
Alzheimer’s disease, which suggests
biomarkers should become more of
a focus, but it stresses that a deeper
understanding of the trajectory of
the biomarkers over time is needed
to determine progression to disease.
Finally, we would like to draw
attention to the power and usefulness
of computer simulations, and to how
they can facilitate progress in clinical
and drug development research on
Alzheimer’s disease. With clearly
defined assumptions, quantitative
data on longitudinal trends of a given
endpoint choice (in a reasonable
sample of patients), and an under­
standing of measurement error, such
simulations can provide insights
into how best to detect signals of
treatment efficacy in a clinical trial,
before the initiation of expensive
phase 3 clinical trials. Trial simulators
facilitate systematic quantitative
analyses of different clinical trial
designs, different endpoint choices,
and different patient inclusion
Published Online criteria.
December 5, 2018
RMA is an independent scientific non-executive
http://dx.doi.org/10.1016/
director of GlaxoSmithKline, holds shares in the
S0140-6736(18)33121-0
GlaxoSmithKline, and receives research funding
support from GlaxoSmithKline for work on
pneumococcal vaccines and the development of
antibiotic drug resistance. GlaxoSmithKline did not
fund this research. RMA also receives research
funding (unencumbered educational research
grant) from Janssen (part of Johnson and Johnson)
for the development of clinical trial simulators and
mathematical models of disease progression.
Janssen and Johnson and Johnson did not
contribute to the writing of this Correspondence or
in the development of its content. All other authors
declare no competing interests.
*Roy M Anderson,
Christoforos Hadjichrysanthou,
Stephanie Evans, Kevin McRae-McKee,
Mei Mei Wong
Published Online roy.anderson@imperial.ac.uk
December 11, 2018
Department of Infectious Disease Epidemiology,
http://dx.doi.org/10.1016/
School of Public Health, Faculty of Medicine,
S0140-6736(18)33165-9
Imperial College London, London W2 1PG, UK
(RMA, CH, SE, KM-M, MMW)
1 Anderson RM, Hadjichrysanthou C, Evans S,
Wong MM. Why do so many clinical trials of
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3 Hadjichrysanthou C, Ower AK, de Wolf F,
Anderson RM, Alzheimer’s Disease
Neuroimaging Initiative. The development
of a stochastic mathematical model of
Alzheimer’s disease to help improve the design
of clinical trials of potential treatments.
PLoS One 2018; 13: e0190615.
4 US Food and Drug Administration. Early
Alzheimer’s disease: developing drugs for
treatment guidance for industry. 2018.
https://www.fda.gov/downloads/Drugs/
GuidanceComplianceRegulatoryInformation/
Guidances/UCM596728.pdf (accessed
Jan 29, 2018).
Department of Error
Oosthuizen JC, Doody J. De-intensified treatment in
human papillomavirus-positive oropharyngeal
cancer. Lancet 2019; 393: 5–7—In the fifth
paragraph of this Comment (published Online
First on Nov 15, 2018), the study by
Maura Gillison and colleagues was incorrectly
referred to as a phase 2 study, rather than a
non-inferiority study. The fourth sentence of
this paragraph should read “This difference
between the two study designs might reflect
regional practice patterns, with cisplatin
commonly substituted with cetuximab in older
patients…”. The hazard ratio result for this study
was incorrectly given as 45·1, and has been
corrected to 1·45. These corrections have been
made to the online version as of Jan 3, 2019,
and the printed version is correct.
Zhang L, Zhong P, Zhai X, et al. Open letter from
Chinese HIV professionals on human genome
editing. Lancet 2018; published online Nov 30.
http://dx.doi.org/10.1016/S0140-
6736(18)33082-4—The web appendix of this
Correspondence has been corrected as of
Dec 5, 2018.
Zelniker TA, Wiviott SD, Raz I, et al. SGLT2
inhibitors for primary and secondary prevention
of cardiovascular and renal outcomes in
type 2 diabetes: a systematic review and
meta-analysis of cardiovascular outcome trials.
Lancet 2019; 393: 31–39—In Figures 1–5,
the format has been changed so that the
columns for the treatment and placebo group
depict the number of patients in each group.
The web appendix has also been updated.
These corrections have been made to the
online version as of Jan 3, 2019, and the
printed version is correct.
Sharmila D. FRONTLINE: a new treatment facility
for Ebola virus disease. Lancet 2018; 392: 2428—
In this World Report, Richard Kojan misspoke
when he said “…we can carry out an abortion or
we can deliver a child in the CUBE”. ALIMA has
assured The Lancet that abortions have never
been carried out in a CUBE. This phrase has been
corrected to “we can carry out lifesaving
interventions in case of spontaneous
miscarriage or we can deliver a child in the
CUBE”. This correction has been made to the
online version as of Dec 11, 2018.
www.thelancet.com Vol 393 January 5, 2019