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Compliance In Focus
Posted by John Lehmann on Fri, Feb 8, 2013

Could Missing Data be Altering Clinical Trial Results?

Could Missing Data be Altering Clinical Trial Results?Clinical trials are a crucial step in the process for new products to reach patients. The information and data those trials yield provide FDA with the evidence to decide whether a product is both safe and effective for the public. But what happens if that crucial information is missing? By only looking at pieces and parts, it’s hard to see the full picture. With out knowing the whole story, could a vital piece of the puzzle be missing? Could missing data put patients at risk?

An article published in US News asks this very question. The article points out that a report from an expert panel commissioned by the National Research Council found “even regulatory guidelines that direct how clinical trials should be run offer little advice on dealing with missing information.”

Missing data can result from many issues in a clinical trial, and according to the article, many factors focus around the patient. In some cases, patients discontinue treatments, do adhere to the follow-up schedule or do not keep accurate notes in a diary for instance.

So, what steps can be made to reduce the likelihood of missing data? The article includes these recommendations which were made by the panel commissioned by the National Research Council:

  • Conducting a brief run-in period in which all participants are assigned an active drug (or device) to see who can tolerate it
  • Targeting a group that doesn't have enough current treatment options, because they have more incentive to stay in the trial
  • Shortening the follow-up period
  • Changes in the statistical analysis of missing data at the end of the study

In cases where data is missing, the article notes that statisticians may be able to help in cases of missing data, but in the en are these just good faith assumptions? Many believe that current methods and analysis that occur at the end of the study need to be improved.

What do you think will help ensure clinical trials yield an accurate picture? Do you think missing data is a problem or are statisticians able to make accurate conclusions? Comment below!

Photo Credit: Kimberly_Herbert

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Topics: Missing Data, US News, FDA, Clinical Research


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