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Patients will be informed if there are major changes to the trial.
No changes to the trial methods were implemented after the commencement of the program.
All changes to the trial protocol are required to be approved by the OHSN-REB.
Changes to the trial (enrollment, design, outcomes) were not made after initiation of the study.
Having a protocol can help to restrict the likelihood of undeclared post hoc changes to the trial methods and selective outcome reporting (see item 6b).
There were 28 trials (24 with a formal DMC), randomizing a total of 79396 participants, identified as recommending changes to the trial that may have lead to biased results.
Similar(53)
There were no changes to the methods or trial outcomes after trial commencement.
Some trials will therefore have important changes to the methods after trial commencement.
We should be wary about making any radical policy changes to the FDA clinical trial and approval process.
The three judges hearing his case have ordered checks on his health and asked all parties to submit suggestions for changes to the future conduct of the trial.
Due to a lack of evidence for major changes to the algorithm before starting the trial, it was decided to include those variables as possible mediators.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com