Clinical Trials: Are We Getting the Data We Need?

The New England Journal of Medicine is hardly a tool of the plaintiffs’ bar. So when the Journal criticizes the lack of complete disclosures in reports concerning clinical trials people should stand up and take notice.

The editor of the Journal says that some companies “are meeting the letter but not the spirit of the law.” Read the study of the compliance rate of drug manufacturers with the federal law that governs clinical trials here.

Here is an editorial written by the Journal staff on the subject. An excerpt: “In our opinion, it is unacceptable for a trial sponsor not to register its trial in a complete, meaningful, and timely fashion. We call for all clinical investigators and patients to participate only in fully registered trials.”

There is another editorial on the subject as well; read it here. Here is a sample of it: “The ultimate goal should be to make trial protocols publicly available in their entirety, including any financial arrangements and agreements with regard to publication, so that patients can be sure that the results will become available. At the same time, it is the responsibility of those who set the rules and establish the registries to make them practical to use and understandable for all kinds of research groups, both small and large.”