Additional trials within scope: a follow-up to our "Call to action: RIAT restoration of a previously unpublished methodology in Gardasil vaccine trials"
On January 11, 2019, we issued a call to action to restore the reporting of multiple trials in Merck’s clinical development program for quadrivalent human papillomavirus (HPV) vaccine (Gardasil) vaccine . In our statement, we had identified problems in the reporting of two Gardasil trials (FUTURE II [NCT00092534] and FUTURE III [NCT00090220]). However we noted that we would begin working on the matter systematically, and “may therefore discover additional trials in need of restoration for the same reason.”
We have now finished assessing all clinical study reports received from the European Medicines Agency, as per our protocol , and identified a further three trials (and their respective publications) which are in need of restoration for the same reason. The three additional trials are:
V501-012 (NCT00092482), published as Garland SM, Steben M, Hernandez-Avila M, Koutsky LA, Wheeler CM, Perez G, et al. Noninferiority of antibody response to human papillomavirus type 16 in subjects vaccinated with monovalent and quadrivalent L1 virus-like particle vaccines. Clin Vaccine Immunol. 2007 Jun;14(6):792-5. https://doi.org/10.1128/CVI.00478-06
V501-013 (NCT00092521), published as Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, et al. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007 May 10;356(19):1928-43. https://doi.org/10.1056/NEJMoa061760
V501-020 (NCT00090285), published as Giuliano AR, Palefsky JM, Goldstone S, Moreira ED Jr, Penny ME, Aranda C, et al. Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. N Engl J Med. 2011 Feb 3;364(5):401-11. https://doi.org/10.1056/NEJMoa0909537
 Doshi et al. Call to action: RIAT restoration of a previously unpublished methodology in Gardasil vaccine trials. 11 January 2019. https://www.bmj.com/content/346/bmj.f2865/rr-7
 Description and rationale for standalone aluminum-containing control arms in Gardasil vaccine trials: restoration of previously unpublished methodology: protocol and procedural manual. 5 Dec 2018. https://doi.org/10.17605/OSF.IO/234KW
Competing interests: The Laura and John Arnold Foundation funds the RIAT Support Center which supports the salaries of Doshi, Jefferson, Jones, Bourgeois, Spence, Shamseer (until 2018), and Hong. In addition: Peter Doshi has received travel funds from the European Respiratory Society (2012) and Uppsala Monitoring Center (2018); grants from the Laura and John Arnold Foundation (2017-20), American Association of Colleges of Pharmacy (2015), Patient-Centered Outcomes Research Institute (2014-16), Cochrane Methods Innovations Fund (2016-18), and UK National Institute for Health Research (2011-14); and is an editor at The BMJ and unpaid member of the Reagan-Udall Foundation for the FDA. Tom Jefferson (TJ) was a recipient of a UK National Institute for Health Research grant for a Cochrane review of neuraminidase inhibitors for influenza. In addition, TJ receives royalties from his books published by Il Pensiero Scientifico Editore, Rome and Blackwells. TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011-13, TJ acted as an expert witness in litigation related to the antiviral oseltamivir, in two litigation cases on potential vaccine-related damage (including the vaccine Pandemrix (2015-2017) and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997-99), GSK (2001-2), Sanofi-Synthelabo (2003), and IMS Health (2013).In 2014 he was retained as a scientific adviser to a legal team acting on oseltamivir. TJ has a potential financial conflict of interest in the drug oseltamivir. In 2014-16, TJ was a member of three advisory boards for Boerhinger Ingelheim. TJ was holder of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews. TJ was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine. Between 1994 and 2013, TJ was the coordinator of the Cochrane Vaccines Field. TJ was a co-signatory of the Nordic Cochrane Centre Complaint to the European Medicines Agency (EMA) over maladministration at the EMA in relation to the investigation of alleged harms of HPV vaccines and consequent complaints to the European Ombudsman. TJ is co-holder of a John and Laura Arnold Foundation grant for development of a RIAT support centre (2017-2020) and Jean Monnet Network Grant, 2017-2020 for The Jean Monnet Health Law and Policy Network. TJ is an unpaid collaborator to the project Beyond Transparency in Pharmaceutical Research and Regulation led by Dalhousie University and funded by the Canadian Institutes of Health Research (2018-2022). Mark Jones was a co-investigator on a UK National Institute for Health Research grant for a Cochrane review of neuraminidase inhibitors for influenza; was a co-recipient of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane reviews; and is a paid consultant on a John and Laura Arnold Foundation grant for development of a RIAT Support Center (2017-2020). LS, HL, FB, KH: no competing interests to declare. OS was a recipient of a Maryland CERSI Scholar award from the Food and Drug Administration (grant #1U01FD005946).