Background: Clinical trial registries have been established as a form of public accountability. Sponsors ought to register their trials promptly and accurately, but this is not always done. Some of the problems include non-registration of trials, registration of trials with incomplete information, and non-reporting of trial results on time. In this study we enumerate or quantify some quality issues with respect to Principal Investigator (PI) and Responsible Party data.
Methods: We analyzed interventional trials registered with ClinicalTrials.gov. Using certain selection criteria, we started with 112,013 records, and then applied further filters. The trial had to (a) start between 1 January 2005 and 31 December 2014, (b) include a "drug" or "biological" in the "intervention" field, (c) be registered with an American authority, and (d) list a real person's name as investigator and also his or her role in the study.
Results: We identified four categories of errors in the ClinicalTrials.gov records. First, some data were missing. The name of the investigator, or his or her role, was missing in 12% of 35,121 trials. In examining 71,359 pairs of names and roles, 17% of the "names" were found to be not those of real persons, but instead junk information. Second, there were variations in a large number of names. We identified 19 categories of variants. We determined that 13% of the names had variants that could not be resolved using a program. Third, some trials listed many PIs each, although only one such person holds overall responsibility for the trial and therefore not more than one person should be listed as PI. Fourth, in examining whether the PI's name was available as part of the Responsible Party tag, we found that in 1221 (3.5%) of 35,121 trials, the Responsible Party tag is absent.
Conclusions: We have outlined four categories of problems with data hosted by ClinicalTrials.gov and have quantified three of them. We also suggest how these errors could be prevented in future. It is important to carry out various kinds of audits of trial registries, in order to identify lacunae in the records, that they be addressed.
Keywords: Biologicals; Clinical trial; ClinicalTrials.gov; Data quality; Database errors; Drugs; Principal Investigator.