Table 4

Selected explanations for registration deficiencies

Explanation
category
Sample quotes
Ambiguity of ICMJE definition of clinical trial"We didn’t include patients in our trial, and didn’t analyze patients’ health outcomes.
"In [our country] studies using prescription databases do not require ethical approval… The intervention on GPs was performed within the continuing medical education (CME) programme, according to the [country] health authority policy."
"As this was not a clinical trial, no registration was obtained."
"There was debate amongst the clinicians and academic staff involved in the project at the very start whether this represented research or a service evaluation, and it was decided to treat it as original research (and seek ethical approval) for completeness."
Comment: In each of these cases, the authors described the study as a trial. In two cases, physicians had been randomised to an educational intervention and outcomes of prescriptions were evaluated. The third study was a cluster randomised trial of an educational intervention for physician groups and evaluated the outcome of medical errors.
Error attributed to another team member or team processes"This resulted from a genuine oversight—simply a mix up between two people who each thought the other had registered the trial."
"Due to the lack of expertise of our sponsor… at that time, ClinicalTrial registration has been initiated but not validated in time. Neither me nor my colleagues were aware and informed of the fact that this process was not well done and all the investigators were in good faith that everything was going well.
You are right, the registration at ISRCTN is effective since [date]. The payment to ISRCTN got delayed at the time, which delayed the effective registration.
As part of the preparation we had the intention to register it on trials.gov, but something must have gone wrong."
"[Our Project Coordinator] was responsible for all registration-related tasks. Unbeknownst to the rest of the research team, [this person] was dealing with a very serious and highly personal issue…This was complicated further by the fact that [this person] was on [medical] leave… The rest of the research team were unaware at the time that anything was amiss, and we proceeded with the research on the assumption that registration was complete."
"The delay of the registration was because our [partners] took more time than expected due to their bureaucratic procedures and delays for translations."
Comment: ICMJE makes it clear that responsibility for compliance with registration requirements lies with the principal investigator.
Requirements should not apply"You are hampering the possible publication of valuable clinical data long awaited by the research community because the trial protocol was not included in a register whose main aim should be to prevent underreporting."
"[The junior investigator who failed to register the study] is a developing country scientist doing this important study alongside a very busy job. Drug companies have whole departments devoted to compliance with regulations and processes like this."
Registry error"Unfortunately, our trial appeared as ’retrospectively registered' due to a database error made by those curating the ISRCTN registry website during a recent upgrade of the system. We have made the ISRCTN team aware of this and details of the trial have now been corrected."
Comment: In three cases ISRCTN changed categorization of a trial from retrospective to prospective when authors supplied information showing the dates they originally provided had been incorrect or ISRCTN had made an error. The reasons for the change were clearly described in the registry entry.
Technical difficulties or misunderstanding of registry instructions"We are somewhat unsure why the submission date say aprill [sic] 2011 on the website, given we started the application over a year before that. We did submit the information before we started enrollment. The only thing we can think [sic] of is that either we did not hit the submit button or NIH took some time to approve it."
"The only thing that was not done was pressing a ’submit' button which was because of a logical (but as it happened incorrect) assumption by [a junior researcher] that the wording on the website meant it should happen when the trial had completed."
Unaware of requirements"We humbly confess the delay in registering the clinical trial that happened partly due to the lack of knowledge about trial registration…"
"About the registration of our trial, the official rule including the official registration in the faculty of Medicine before it should be reviewed by ethical committee. Today I send you the official certificate of ethical committee. Tomorrow, I will try to send you the official number of registration of this trial in our faculty."
"This was a prospective randomised controlled trial… The registration of the trial being delayed does not dispute it being a prospective trial but just that there was a delay in registering the study on the clinicaltrials.gov website."
"We do not know what retrospective is, but it surely does not apply to us."
"However, it was registered later on clinicaltrials.gov mainly because when we considered ethic and legal issues, we came to the conclusion that this registration was not mandatory."
  • GP, General Practitioner; ICMJE, International Committee of Medical Journal Editors; ISRCTN, International Standardised Randomised Controlled Trials Number.