The trials of clinical research...

Clinical trials and especially the "gold standard" of research--the randomized controlled trial have fallen on hard times. In a market economy where health cost and drug prices are business driven commodities there are many blurred lines and arched eyebrows. How do we qualify the "evidence" in evidence-based medicine?

In an attempt to avoid throwing the baby out with the bathwater, learning a few insights to help evaluate the rigor of endless research findings may be of help.

“Journals have devolved into information laundering operations for the pharmaceutical industry”--Richard Horton, editor, Lancet New York Review of Books, March 11, 2004

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“The pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the U.S. Congress, the Food and Drug Administration, academic medical centers, and the medical profession itself."-- Marcia Angell, former editor, NEJM

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Here are a few potential red flags worthy of closer scrutiny...

• Trial against placebo
• Trial against treatment known to be inferior
• Trial against low dose of competitor
• Trial against high dose of competitor (to give advantages on toxicity)
• Equivalence or non-inferiority trial that is too small to show a difference from competitor drug
• Use multiple endpoints and select the ones that give positive results
• Subgroup analyses and select positive results
• Suppress (don’t write up) negative studies
• Publish positive studies more than once—perhaps in supplements
• Do multi-center trial and publish results of individual centers—perhaps selectively
• Publish different outcome measures at different times
  
• Publish different follow periods at different times—3 month results, one year, two year

• Publish positive results in major journals and negative or neutral results in minor journals
  
• Combine results of trials in ways that are favorable
  

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Statistics utilized in clinical research can also aid and abet in misleading information.

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There are also open-access journals to consider...

The Public Library of Science (PLOS) has been publishing a peer-reviewed, open access journal since 2006. It publishes the most papers of any journal in the world, covering primary research from all disciplines within science and medicine.

As medical writers we need to be mindful of the resources we use to develop a narrative. The data informs findings but we have a responsibility to understand what we are analyzing or reviewing. 

My favorite quote (used in my email signature) may be an appropriate close for this blog:

"Statistics are like swimwear - what they reveal is suggestive but what they conceal is vital." 
-Ashish Mahajan, Lancet 2007

“We have decided not to be part of the cycle of dependency that has formed between journals and the pharmaceutical industry, an industry that focuses overwhelmingly on the most profitable drugs, thus sidelining many of the world's health problems. Medical journals have allowed their interests to become aligned with those of the pharmaceutical industry by printing advertisements for drugs, publishing trials designed by drug companies' marketing departments, and making profits on reprints used as marketing tools.”--Editors of PLOS Medicine: “Prescription for a healthy journal  

  

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