[fusion_builder_container hundred_percent=”no” hundred_percent_height=”no” hundred_percent_height_scroll=”no” hundred_percent_height_center_content=”yes” equal_height_columns=”no” menu_anchor=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”center center” background_repeat=”no-repeat” fade=”no” background_parallax=”none” enable_mobile=”no” parallax_speed=”0.3″ video_mp4=”” video_webm=”” video_ogv=”” video_url=”” video_aspect_ratio=”16:9″ video_loop=”yes” video_mute=”yes” video_preview_image=”” border_color=”” border_style=”solid” margin_top=”” margin_bottom=”” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” type=”legacy”][fusion_builder_row][fusion_builder_column type=”3_5″ layout=”1_1″ spacing=”” center_content=”no” link=”” target=”_self” min_height=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=”” background_color=”” background_image=”” background_position=”left top” background_repeat=”no-repeat” hover_type=”none” border_color=”” border_style=”solid” border_position=”all” padding_top=”” padding_right=”” padding_bottom=”” padding_left=”” margin_top=”” margin_bottom=”” animation_type=”” animation_direction=”left” animation_speed=”0.3″ animation_offset=”” last=”false” border_sizes_top=”0″ border_sizes_bottom=”0″ border_sizes_left=”0″ border_sizes_right=”0″ first=”true” spacing_right=””][fusion_text columns=”” column_min_width=”” column_spacing=”” rule_style=”default” rule_size=”” rule_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””]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.[/fusion_text][fusion_accordion type=”toggles” boxed_mode=”yes” border_size=”1″ border_color=”” background_color=”” hover_color=”” divider_line=”” title_font_size=”” icon_size=”” icon_color=”” icon_boxed_mode=”” icon_box_color=”” icon_alignment=”” toggle_hover_accent_color=”” hide_on_mobile=”small-visibility,medium-visibility,large-visibility” class=”” id=””][fusion_toggle title=”Step 1: Obtain clinical study reports and any other study data” open=”no”]

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

[/fusion_toggle][fusion_toggle title=”Step 2: Collect documentation of non-publication or misreporting” open=”no”]

For unpublished trials: No primary publication detected by systematic search of the literature and/or confirmation from original trial sponsor or current responsible party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.

[/fusion_toggle][fusion_toggle title=”Step 3: Issue a Call to Action by publicly registering your possession of data sufficient for publication” open=”no” class=”” id=””]Issue a “call to action” by publicly registering your possession of data sufficient for publication.

At least initially, this should be through 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; also request them to signal their intent to publish or formally correct their study by sending an electronic response to the article within 30 days. If the responsible parties declare an intention to publish or correct, but do not do so within one year, all available data for such trials should be considered “public access data” that others are allowed to publish.[/fusion_toggle][fusion_toggle title=”Step 4: Collect documentation of trial abandonment and need for restoration” open=”no”]

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.

[/fusion_toggle][fusion_toggle title=”Step 5: Presubmission inquiry to RIAT-friendly journal” open=”no”]

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.

[/fusion_toggle][fusion_toggle title=”Step 6: Prepare and submit manuscript according to RIAT procedures” open=”no”]

  • 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

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Additional RIAT Considerations/Recommendations

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  • 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.

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