Letters: IU must up game in clinical trials

The business and the scientific community should be completely baffled by the recent announcement that Eli Lilly and Co. is donating $40 million to Indiana University to develop/enhance its clinical trial capability in various areas where Lilly is developing new treatments [“Lilly, IU sign clinical trial, research agreement worth up to $40M,” IBJ.com, Dec. 3].

One would think that IU would already be teaching its medical students about new drug development and how various types of studies are required to get a new drug on the market. One would think that IU already has the infrastructure in place to implement those trials from Phase I-VI.

The reality is that there is a disconnect between what you hear from IU about its clinical trial capability and what I hear directly from the pharmaceutical industry when a site is being chosen to participate in one of its trials. I can only give you my experience in Phase II and Phase III trials in the outpatient cardio-metabolic area (hypertension, obesity, cholesterol, etc.) in which I participate.

The story is always the same. The bureaucracy of IU (e.g. contracts, committees, IRB, staff, etc.) prevents it from meeting the needs of industry. To meet the needs of the competitive environment for new drug development, a site must be “up and running” in weeks not months and months with a dedicated team, including investigators.

Since 1988, I have participated in over 560 trials in the cardio-metabolic area as a private, dedicated, clinical trial site. Most recently, with the explosion of the GLP-1 drug development, my site has participated in 16 trials and many scheduled for next year.

I do not fault Lilly for making its charitable donation to IU. Over the years, Lilly has been extremely generous to our city and state in various ways.

I do fault IU for not already having a well-developed clinical trial system suitable for the real world of drug development. Over the years, it seemed to have only focused on NIH research funding. Well, those days are over in the current political environment.

—Dr. Phillip Toth
Midwest Institute For Clinical Research