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Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial

BMJ 2014; 349 doi: https://doi.org/10.1136/bmj.g5579 (Published 19 September 2014) Cite this as: BMJ 2014;349:g5579

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We confirm that for all the trials selected, we extracted the email addresses of responsible parties (sponsors or principal investigators, or both) from ClinicalTrials.gov. The search was performed on August 20, 2012, and at this date a contact name and an email address could be found on ClinicalTrials.gov for most of the trials, even when these trials were completed. 1

The letter from Harrison et al. is of great interest. It highlights a change in policy by the National Library of Medicine whereby all email addresses for completed trials are removed from ClinicalTrials.gov. 2 We were very surprised by this change in policy because it is not consistent with the World Health Organization (WHO) recommendations. According to the International Standards for Clinical Trial Registries, edited by the WHO, “The contact for scientific queries must therefore include: i) Name and title, email address, telephone number, postal address and affiliation of the Principal Investigator, and; ii) Email address, telephone number, postal address and affiliation of the contact for scientific queries about the trial (if applicable). 3

We agree with the authors that the removal of contact information for closed studies has deleterious consequences on transparency of research, particularly for researchers performing meta-analyses and all patients and stake-holders interested in the results of a trial.

Annabel Maruani, Isabelle Boutron, Gabriel Baron, Philippe Ravaud

References
1. Maruani A, Boutron I, Baron G, Ravaud P. Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial. Bmj 2014;349: g5579.
2. O’Neill S, Wigmore SJ, Fitzgerald JE, Bhangu A, Harrison EH. Investigator contact details should continue to be available after completion of clinical trials. http://www.bmj.com/content/349/bmj.g5579/rr/768390
3. WHO Library Cataloguing-in-Publication Data. International standards for clinical trial registries. 2012. P.24 http://apps.who.int/iris/bitstream/10665/76705/1/9789241504294_eng.pdf (October 27, 2014)

Competing interests: No competing interests

27 October 2014
Annabel Maruani
Professor
Isabelle Boutron, Professor; Gabriel Baron, Statistician; Philippe Ravaud, Professor and Director
Assistance Publique-Hôpitaux de Paris, Hôpital Hôtel-Dieu, Centre d'Epidémiologie Clinique, Université Paris Descartes-Sorbonne Paris Cité, INSERM U1153, Paris, France.
Hôpital Hôtel-Dieu, Place du Parvis Notre-Dame, 75004 Paris, France