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"The whole purpose of this letter is so that they can reassess whether this is an ethical trial going forward, but the step-by-step ethical flaws and problems with the Tide trial are not even referenced".
The use of systematic reviews should be encouraged to inform rational, and thus ethical, trial design and improve the relevance of new research.
Such challenges to good communication can lead to lapses in GPP and even in some case to lapses in ethical trial conduct.
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The drug companies have been known to practice some less than ethical trials on those who are either too poor or too desperate to know better, while there have been numerous accusations leveled at some of the participating governments of misappropriation of funds and widespread corruption.
Sound science encompasses adequate reporting, and the conduct of ethical trials rests on the footing of sound science.
The study was approved by the Dutch Union of Medical-Ethical Trial Committees for mental health organizations.
Ethics committees are supposed to ensure scientific soundness and relevance of clinical investigations, preventing enrolment of participants in non-ethical trials.
In the setting of multicentre trials, neglecting the execution strategies of ethical conduct, trial organisation and funding procurement poses both ethical and pragmatic barriers to the successful conduct of a RCT.
The study was approved by the local ethical committee (trial register: CEP 0480.10 UNIFESP) and all subjects signed an informed consent form before participation.
In clinical research, even if debated on ethical grounds, trial designs using placebo control groups yield the most reliable information on the effectiveness of new drugs.
Despite the fact that some clinical performance targets have been chosen based upon observational data and consensus (and could never be part of an ethical randomized trial), the value of observational data should not be overstated.
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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