General recommendations for how to restore a trial were published in the BMJ in 2013. The basic steps are listed below, and in the video.

To carry out a restoration, you must gain access to sufficient trial data and documents.

For unpublished trials: No primary publication detected by systematic search of the literature and/or confirmation from original trial sponsor or current responsible party that no publication exists
For misreported trials: Evidence of misreporting (ideally, published letters or other articles in the scientific literature or documentation of communication with the original trial publication author(s) detailing the misreporting) and a failure to correct the scientific record.

Issue a “call to action” by publicly registering your possession of data sufficient for publication.

At least initially, this should be by a rapid response to BMJ paper and should include, as a minimum, trial identifiers, number of participants, date completed, publication status, pages in your holding, and level of access to trial data. This declaration offers original sponsors and trialists an opportunity to publish or formally correct their studies within the next 365 days. Send a copy of the rapid response by email to trial sponsors (and authors, for published trials), requesting confirmation of receipt.

Save time stamped copies of all rapid responses to this article (or other relevant websites) to document the time elapsed and consequent need for third party restoration.

Find a RIAT-friendly journal and submit a presubmission inquiry to gauge journal interest.  Your inquiry should present editors with documentation from steps 1-4 and seek confirmation of editors’ interest in receiving a RIAT manuscript.

  • Include explanation (with references) in the Introduction of why this trial is being restored
  • Provide auditable record of decisions (use RIATAR template), documenting which parts of the clinical study report (page number and paragraph) were used
  • Report analyses specified in protocol
  • Denote any analyses that were not prespecified
  • Make all underlying data available electronically

Additional RIAT Considerations/Recommendations

  • Trial registration. Check to ensure that the trial is registered in a unique identification number e.g. for clinicaltrials.gov the unique identifier is an NCT number.
  • Making data publicly available. RIAT is premised on the concept of publishing trials with underlying data publicly available.  Sometimes however doing so is not straightforward.  We will provide further details on this soon.
  • Authorship. The decision on whether to involve the original investigators or sponsors in a RIAT publication is up to the RIAT authors.  The RIAT Support Center is not prescriptive on this point.