September 04, 2008
Investigator-Initiated Trials Grow Up, Fast
I recently returned from a conference in Philadelphia, where William Penn presided over a number of speakers addressing issues concerning Investigator Initiated Trials. While every company has a different acronym for the process that we at CEI refer to as IITs, they all seem to be facing a number of the same issues. These issues - and the conference itself - are a rather new occurrences as the IIT phenomenon has evolved into a whole other animal.
In our research, CEI has found the number of companies formalizing the IIT process and establishing dedicated departments to handle the process is starkly rising. If a company does not have some kind of formal process by now, somewhere in a corporate office a light is burning deep in the night to put one in place. If a company doesn't have a dedicated department, or at least some dedicated personnel, and this type of work intrigues you, apply for a job at that company.
Far from its inglorious past as a MSL's or sales rep's tool to keep important KOLs happy with a company, IITs have become a central tenet of many company's clinical strategy. As the number of NIH-sponsored/funded studies decline, the number of IITs, or industry funded studies in academic or independent arenas climbs precipitously.
Such a volume has caused pharma to look closer at its interactions with independent investigators and its utilization of the research it monetarily supports. No longer are companies writing off the money as a thought leader expense - they are looking for clinical returns.
Interestingly enough, a number of the conference topics sounded like I had accidentally landed in a meeting discussing thought leader interaction, recruitment and retention. I heard the bombshell acronym of FMV dropped as well as discussion about ethical funding concerning academia. Then I met a researcher from the University of Michigan attending the conference. Obviously, her interest there came from the burnished other side of the coin. With government funding declining, university research institutes want to know the best methods to land some IITs at their respective research institute.
This is all a very interesting contrast to this past year's turmoil over physicians and researchers working for academia and the industry. Yesterday's hubbub about academia consorting with the wolf is today’s collective voice of a research choir. Of course, the distinction lies with the method by which pharma funnels and applies the money the institute receives. Since pharmaceutical companies do not own the data produced from IITs, there falls less pressure to draw bold and wide ethical lines. Yet, with IITs becoming a big part of companies' clinical strategy and budget belts notching in, companies continue to expand their supervision of the studies. This shift towards closer ties brings a few questions to the table.
First and foremost, in attempts to ensure investigators are not influenced by salaries, regulation now stipulates fair-market-value payments. Yet, just like in thought leader activities, what is fair-market value beyond some abstract tautology? Can companies turn to the same benchmarking that supports their payments for thought leaders as a guide for investigators? Moreover, will all these payments now need to be made publicly accessible?
When does an investigator become a thought leader and do the rules change at that point? Ostensibly, there is very little difference between an investigator presenting trial data and a thought leader giving a scientific or educational speech. If an investigator writes an abstract at the end of a trial, or makes a presentation, can the payments and relationship come under the scrutiny of state laws regarding physician/thought-leader interaction? What about stringent academic policies at certain institutes that have recently passed, such as in Colorado, concerning physician relationships with pharma? Could acts such as the prospective Sunshine Act put forth by Charles Grassley come into play when investigators start reporting on findings? Companies and investigators alike are wise to already be discussing the best ways to include milestone payments and end-result payments into the original contractual agreements. But will these contracts be required to be made public?
Of course, the major difference lies in ownership of the data, but don't the lines converge somewhere on the investigators side of a CME forum? They both aim towards research and education, with no promotion, regardless of the results, with pharmaceutical companies distantly providing the funding. One thing is for certain, the more these types of studies proliferate, the more regulatory involvement will grow.
Posted by Jordan Stone at 06:43 AM | Comments (0)