There is growing recognition in the US pharmaceutical industry of the value of investigator-initiated clinical trials (IIT), with spending on IITs expected to increase by 42% this year.

Increasingly IITs are viewed as a critical ingredient in building scientific support for a new drug or new indication, rather than a piecemeal approach to filling in the blanks left by a company's own development programme. At the same time, though, many US companies have been slow to create the internal structures that will optimise use of IITs and avoid any liability or other problems they may cause, a new report warns.

Research conducted by Cutting Edge Information for the report, Managing Investigator Initiated Clinical Trials: Structure, Process and Strategy, found that IIT spending by participating companies was expected to rise from an average of $4.3 million per company in 2005 to $6.1 million in 2006. Over the same period, the average number of IIT proposals evaluated by companies was expected to increase by 24% and the average number of IITs started in the clinic by 26%.

Jon Hess, senior researcher at Cutting Edge Information, believes pharmaceutical companies are paying more attention to IITs now because investigators' interests reflect the needs of the market and, more pragmatically, because the originators sometimes “got burnt” by not paying enough attention in the past.

When brand teams only find out about IITs after the event, they are not only wasting a potential opportunity but laying themselves open to potential liability, he explained. For example, if lack of internal co-ordination means one investigator is awarded a grant for an IIT proposal that was refused from a previous applicant, the first investigator may sue the company for theft of intellectual property.

From a less defensive standpoint, information drawn from IITs may be particularly valuable in steering a company's medical publications strategy, such as getting the message out to physicians about off-label uses, Hess noted.

It may also serve as a prompt for new research ideas, which the supporting company can then follow up with its own study to generate more robust data. IITs are usually Phase IV studies conducted on smaller populations to answer questions unresolved by the narrower scope of trials geared to regulatory approval. They may investigate appropriate dosing regimens for a new drug or its safety and efficacy profile in special populations such as children or the elderly.

These benefits may be squandered, however, if companies do not get a grip on IIT funding and oversight within their own organisation. According to Cutting Edge Information, they should be looking at dedicated IIT management departments and centralised processes for the evaluation, acceptance and tracking of IIT proposals.

In a survey conducted for the report, half of the respondents said they lacked dedicated resources for the management and/or oversight of investigator-initiated studies. By Peter Mansell