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Correspondence

bodies, sponsors, investigators, and legal requirement seems widespread,


funding agencies—as responsible yet, to our knowledge, the FDA has
for ensuring that “results from all not issued a fine since the law was
interventional clinical trials are enacted in 2007. Clinical investigators’
reported and publicly disclosed.” 3 professional and ethical commitments
Similarly, Goldacre notes that audits to advance knowledge and clinical
can be completed locally (eg, by ethics care through research are recognised,
committees), centrally (eg, by funding but, to our knowledge, no disciplinary
agencies), or ideally both.2 However, action against an investigator has been
by suggesting that the responsibility taken by a professional body, academic
for clinical trial disclosure and audit institution, or research hospital for not
is distributed among many creates making research results transparent. Department of Error
the very real risk that nobody will take We recognise that WHO’s public Cox TM, Drelichman G, Cravo R, et al. Eliglustat
on this responsibility; the scope of disclosure statement is important compared with imiglucerase in patients with
Gaucher’s disease type 1 stabilised on enzyme
this issue can be seen with respect to and disclosure of results is a collective
replacement therapy: a phase 3, randomised,
present practice. action problem that involves many open-label, non-inferiority trial. Lancet 2015;
All of those named by WHO and actors. However, the laudable goal 385: 2355–62—In supplemental table C in the
many other actors (such as scientific of public disclosure of all clinical trial appendix, the first column and second row
should have read “Imiglucerase (N=45)”, the
journals, research institutions, and results will remain aspirational unless third column and 11th row should have read
universities) already have ethical, specific responsibilities are attributed “–0·10 (1·07)”, the second column and
if not also legal, responsibilities to every relevant actor; moreover, 12th row should have read “–0·47 (1·29)”, the
third column and 13th row should have read
to ensure that all clinical trials are mechanisms and adequate funding “0·13 (1·03)”, and the second column and
registered and all research results are must be put in place to undertake 14th row should have read “–0·18 (1·12)”.
reported. For example, research ethics and help to coordinate these These corrections have been made to the
online version as of June 12, 2015, and the
committees are supposed to only responsibilities across all actors. printed Article is correct.
approve research with a favourable Without well resourced and
(or at least proportionate) benefit-to- coordinated enforcement, we worry The SCOT-HEART investigators. CT coronary
harm ratio. For research in which the that WHO’s statement, like those angiography in patients with suspected angina due
to coronary heart disease (SCOT-HEART): an open-
only potential benefit is knowledge, preceding it, will be more “honor’d in label, parallel-group, multicentre trial. Lancet
the prospective favourable benefit- the breach than the observance.”6 2015; 385: 2383–91—In this Article, data in the
to-harm ratio is wholly dependent We declare no competing interests. further investigations row were misaligned in
table 1. This correction has been made to the
on the resulting knowledge being online version as of June 12, and the printed
made publicly accessible.4 However, Françoise Baylis, *Matthew Herder
Article is correct.
matthew.herder@dal.ca
little evidence shows that research
Faculties of Medicine (FB, MH), Arts and Social Bilano V, Gilmour S, Moffiet T, et al. Global trends
ethics committees factor clinical trial
Sciences (FB), and Law (MH), Dalhousie University, and projections for tobacco use, 1990–2025: an
registration into their analysis of Halifax, NS, B3H 4R2, Canada analysis of smoking indicators from the WHO
potential risks and benefits, much less 1 WHO. WHO statement on public disclosure of Comprehensive Information Systems for Tobacco
enforce registration and reporting of clinical trial results, 2015. http://www.who. Control. Lancet 2015; 385: 966–76—In this
int/ictrp/results/reporting/en/ (accessed Article (March 14), in the Findings section of
results through annual monitoring of May 15, 2015). the Summary the number of countries in
approved protocols. 2 Goldacre B. How to get all trials reported: which tobacco smoking prevalence in women
Similarly, regulatory authorities, audit, better data, and individual fell should have read “155 (87%)”. In the first
accountability. PLoS Med 2015; 12: e1001821. paragraph of the Results section the number
research sponsors (both public and 3 Moorthy VS, Karam G, Vannice KS, Kieny MP. of low-income or middle-income countries in
private), and investigators have Rationale for WHO’s new position calling for the first quintile of tobacco smoking
diverse obligations to promote the prompt reporting and public disclosure of prevalence in women should have read
interventional clinical trial results. PLoS Med “(26 [84%] countries)”. In the sixth paragraph
pursuit of scientifically and ethically 2015; 12: e1001819. of the Discussion, the sentence about tobacco
sound research. These obligations 4 Levin LA, Palmer J. Institutional review boards control landscape should have read “less than
should require clinical trial registration.
seem to be routinely breached with Arch Intern Med 2007; 167: 1576–80.
1% of the male population” and “36% of the
female population”. In the appendix tables 6
impunity—eg, in the USA the US 5 Anderson ML, Chiswell K, Peterson ED, and 7, columns in the high-income section for
Food and Drug Administration (FDA) Tasneem A, Topping J, Califf RM. Compliance
women were displaced, and in table 7 the
with results reporting at ClinicalTrials.gov.
has a mandate to impose a fine of N Engl J Med 2015; 372: 1031–09.
mean prevalence year was incorrectly listed as
no more than US$10 000 per day for 2010 rather than 2025 and prevalence
6 Shakespeare W. The tragedy of Hamlet, prince
quintiles for women in high-income countries
every day that a clinical trial’s results of Denmark: act 1, scene 4. In: The complete
works of William Shakespeare. London: Abbey were incorrect. These corrections have been
are not reported 1 year after it is Library, 1974: 852. made to the online version as of June 12.
completed.5 Non-compliance with this

2354 www.thelancet.com Vol 385 June 13, 2015

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