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