Ethics Week - Lost Evidence, Unpublished RCTs

Written by Clay Smith

Spoon Feed
Nearly 90,000 patients were enrolled in randomized trials that were never published. These patients were enrolled in good faith that their participation would benefit future patients. The key issue: “Large unreported trials threaten the credibility of the available, published evidence.”

Why does this matter?
Failure to publish a trial is considered to be a form or professional misconduct by some. Actual people were enrolled, potentially inconvenienced, or faced unknown risks in some cases; yet, the results of these studies never saw the light of day to inform the scientific community of the results. Loss of evidence is an important ethical issue that is unseen - we don’t notice what’s not published.

What we don’t know may hurt our patients
Researchers found 146 RCTs registered on ClinicalTrials.gov that were completed but long unpublished. Over time, more of these were published, but as of January 2019, 67 trials, with a median enrollment of 765 patients, remained unreported for a median time from completion of 9 years. That’s 83,883 patients, who in good faith allowed themselves to be enrolled in a clinical trial for the greater good of future patients. Yet, the researchers never published the results. This is wrong. Knowledge has been lost in the fields of: “cardiovascular disease (n = 13), infection (n = 12), psychiatric diseases (n = 9), women's health and obstetrics (n = 6), allergy (n = 5), and neurologic diseases (n = 5).” One may question if this matters, since most of these were negative studies, finding no effect. The authors nailed it: “Large unreported trials threaten the credibility of the available, published evidence. One should be cautious in combining published trials and interpreting them when extensive results remain undisclosed.”

Source
Lost Evidence From Registered Large Long-Unpublished Randomized Controlled Trials: A Survey. Ann Intern Med. 2019 May 7. doi: 10.7326/M19-0440. [Epub ahead of print]

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