Legacy and Terminated Studies
When entering Basic Results for legacy studies (i.e. studies starting 2007 and earlier) with limited data accessibility or older studies that changed significantly from the time that they were first registered, one may attempt to punt via adding a link to the publication preceded by the following descriptive text (edit text as needed) under the “Basic Results/Limitations and Caveats” section (note: there is no guarantee this will be accepted by the clinicaltrials.gov office but it’s worked in the past for some SKCCC trials):
“The raw study data is no longer available for this study [or] the design of this trial changed significantly from when it was first registered. The study’s publication can be accessed here: [www.webaddresshere.com].”
How do I submit results information if the trial is terminated (that is, stopped prematurely) and no data were collected for one or more Outcome Measures?
- If no participants were ever enrolled in the trial, set the Overall Recruitment Status to Withdrawn, and no further results information will need to be submitted.
- For a trial that was terminated after participants were enrolled, provide any available data. If no data are available for any of the Outcome Measures, specify zero (“0”) for the Number of Participants Analyzed in each Arm/Group, and leave the data fields blank. Provide an explanation in the Analysis Population Description or the Limitations and Caveats module.