A witness in the 2008 case Pfizer lost for making false presentations about epilepsy drug Neurontin, Kay Dickersin, published a piece in open-access journal PLOS that highlights problems with the current state of published clinical trial data.
At issue are clinical trial documents Dickersin reviewed with colleagues that cross-referenced clinical trial data for off-label use of the drug against internal documents about these same trials. They found a lot of daylight between the corporate and public versions, leaving researchers “unable to compare the internal research report with the main publication”—for variables such as the number of participants or even a consistent form of analysis. On the in-house communications side, Dickersin's team also found that Pfizer's documentation showed that the published trials “did not always accurately reflect what was actually done in the trial.” Dickersin had access to the internal documents—which she noted are not generally available—because of the lawsuit.
Among the points of contention: internal and published documents used different definitions for the term “premature discontinuation” among three of 11 trials examined. They also found that in six out of 10 trials researchers couldn't match up company data with published data regarding how many patients were used to assess efficacy because the type of analysis wasn't defined or a primary outcome wasn't established.
Dickersin told MM&M
that the experience shows “we have to get some standardization of terminology so that people know what we're talking about.” This includes the initial endpoints, patient criteria and definitions. She said that will mean documents and published information can be compared “and we can see that there hasn't been any changing of the goal posts.” She said that GSK's recent clinical trial transparency effort is in line with the EMA's rules, and that it's FDA's turn to put standards in place.