Anti-kickback laws prompting drugmakers to closely monitor IITs

Pharmaceutical companies are keeping close checks on the investigator-initiated clinical studies of their drugs, often referred to as investigator-initiated trials, or IITs.

For years, such trials were supported by drug companies, primarily in the form of grant money supplied to investigators who approached the companies with novel investigative ideas. However, such support went largely unchecked - companies lacked centralized resources for IIT oversight and, in many cases, product teams were not even aware that tests of their drugs were being supported from elsewhere within the company, comments a new report from pharmaceutical business intelligence firm Cutting Edge Information.

Over the past several years, it says, concerns about exposure to legal liability, primarily from the US Department of Justice/Office of Inspector General anti-kickback laws, have elevated the importance of IITs, which have captured the attention of senior management at the many pharmaceutical companies that are building dedicated departments. These departments, usually housed within the medical affairs or clinical development function, help keep tabs on the investigator-run trials.