Patient Safety Risks Associated with Clinical Trials

June 04, 2011

Medical researchers are discounting previously published and accepted research when reporting on their own clinical trials of drugs, devices or medical procedures, according to a recent Johns Hopkins study published in the January 4 issue of Annals of Internal Medicine.

The report says that researchers' dismissal of relevant research causes redundancy in reporting and wastes resources, specially funding. Less than 21 percent of previous studies and clinical trials were cited in newer research, a very low number given the wealth of accepted papers available, according to the study.

The reason, the study maintains, could be self-interest.

Many clinical trials are funded by large grants, and to obtain these grants, researchers have to state their expected expenses. By outlining reliance on previously accepted research, which would preclude additional work, researchers would receive reduced grant awards.

Researchers claim that their studies are unique and require fresh reviews apart from previously published work that may have touched on the same subject. There are no guidelines for duplicating previously accepted studies.

John Hopkins' study suggests that duplicating clinical trials has no value and is a waste of taxpayer funding. Simply doing some homework to review previous work could not only save time but also money, the study says.

One of the study's authors noted that not looking at existing evidence is "like listening to one witness as opposed to the other 12 witnesses in a criminal trial and making a decision without all the evidence. Clinical trials should not be started--and cannot be interpreted--without a full accounting of the existing evidence."

Implications for Patient Safety

A new review or trial could provide results different from those in previously accepted studies and could put patients at risk during trials that in essence had already been conducted.

In some instances, clinical trials volunteers could receive a placebo for a medication that a previous study has already determined to work or receive medication that has been found dangerous, raising informed consent issues. In other instances, patients have suffered severe side effects, resulting in seriously injuries or even wrongful death, because researchers were not aware of previous studies outlining the danger of the treatment.

Article provided by Carty Houst PA
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