Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trialBMJ 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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Re: Impact of sending email reminders of the legal requirement for posting results on ClinicalTrials.gov: cohort embedded pragmatic randomized controlled trial
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
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
For successful translation of results from research into practice there must also be timely dissemination of research findings (1). The Food and Drug Administration Amendments Act requires trials that are subject to mandatory reporting to post results within 12 months of study completion on ClinicalTrials.gov (2). Despite this initiative, less than a quarter of trial investigators comply (3).
Maruani and colleagues report that email reminders of the legal requirement to post results significantly improve reporting six months (4). Any intervention that increases dissemination of clinical trial results is welcome and the authors should be commended for their efforts.
However, we do not understand the authors’ described methods. They report that the cohort included trials “that had available contact details (email addresses) of responsible parties”, and go on to state that they “extracted the email addresses of responsible parties from ClinicalTrials.gov”. In the discussion they highlight “the need for updating email addresses of responsible parties in ClinicalTrials.gov”.
We would be interested to know how this is possible as all email addresses for completed trials are removed from ClinicalTrials.gov as a matter of policy by the National Library of Medicine (Table 1).
We asked the National Library of Medicine (NLM) to comment on this. In addition, we asked what advice they would give a patient who had taken part in a completed clinical trial, and wished to contact the investigators to enquire about trial results. They responded:
“If the record is closed or completed, we remove all contact information in the location and contact section since there is no reason why a potential patient would need to contact them.”
The NLM will not provide contact email addresses on request, despite these previously being available on ClinicalTrials.gov while the trial was recruiting.
The removal of previously published contact information from ClinicalTrials.gov has important implications for transparency in trial reporting. Interventions, such as that proposed by Maruani, cannot be delivered at scale while this practice exists. Searching for contact details manually with Google or Pubmed is difficult at best and impossible for many, who may include patients that have participated in a study and wish to contact the investigators about trial results.
1. Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. Bmj 2012;344: d7292.
2. Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database--update and key issues. N Engl J Med 2011;364(9): 852-860.
3. Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. Bmj 2012;344: d7373.
4. 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.
(1) Clinical Surgery, University of Edinburgh, Royal Infirmary of Edinburgh, Edinburgh, EH16 4SA, UK.
(2) UCL Medical School, University College London, Gower Street, London, WC1E 6BT
(3) University of Birmingham, College of Medical and Dental Sciences, West Midlands, B15 2TH
Competing interests: No competing interests