NickCEBM
commented
6 years ago Just wanted to pull some relevant text from the Final Rule into here:
Page 65109:
Proposed § 11.64(a)(1) established a general requirement for responsible parties to update clinical trial information not less than once every 12 months if there are changes to any of the data elements previously submitted. Section 11.64(a)(2) emphasized that this requirement to update clinical trial information not less than once every 12 months includes a requirement to update the estimated Primary Completion Date data element, unless there have been no changes in the preceding 12 months. We noted that, in our view, the public should be able to rely upon the accuracy of this date to assist them in determining when results information may be available on ClinicalTrials.gov.
Some trials (only around 22 at present) have a "null" completion date. We are going to exclude them at launch.
However it is important that sponsors are not exempted from public accountability by failing to maintain their public registry data.
Therefore at some stage in the future we should implement an additional feature to manage this category.
We could do either of:
Flag them as "Bad Data" and report separately like we do on EUCTR (where the problem is much more prevalent).
Impute that they are due, i.e. give them a completion date of Jan 17 2017, and say that they are due; if sponsors disagree then they can update their data, and be motivated to do so through public censure for overdue-ness.