One of the biggest causes of clinical trial soaring costs is a lack of patient enrollment in these studies. It is my belief that this problem can be significantly reduced by getting more physicians involved in clinical research, and keeping them there once they start conducting their own studies as Principal Investigators.
There are essentially only two types of clinical research: academic and private industry clinical trials. While academic research is certainly important, 85% of clinical research is private industry funded and the biggest need for physician Principal Investigators lies there. Furthermore, with Trump recently slashing 20% of the NIH's research funding, we may even see the percentage of private research increase even further.
The types of physicians that the clinical research industry is in desperate need of are physicians with robust and established private practices of their own, to which adding a clinical research revenue stream would not only be financially favorable, but also add a certain element of prestige to the physician's brand.
In this video I discuss the benefits of a physician become a clinical research principal investigator.
Seems like every physician with a healthy customer (patient) base should be jumping at the opportunity to conduct research and be wildly profitable! In reality this is far from the case. There is an alarming statistic which shows that 90% of principal investigators who conduct their first clinical trial never do a second one. I believe this is due primarily to two reasons: 1.) they botched their first trial so badly that no Sponsor wants to work with them again, or 2.) they were overwhelmed with the paperwork and frequent housekeeping requests from their monitors that arise during the course of any trial that the physician gave up on the notion of clinical research altogether.
I believe that the clinical research industry and medicine in general would be better off if there were more physicians participating successfully in clinical research. First of all, I believe it would eliminate a huge chunk of the patient recruitment problem. Physicians deservedly have a lot of influence over their patients and if a clinical trial is recommended to a patient by their physician, they would be more likely to join a trial. Secondly, getting a physician to prescribe a drug that has been FDA approved would be a lot more frictionless of an event if that same physician also participated in the associated clinical trials. Why is there not an industry-wide push towards this? I believe it boils down to short term vs long term risk/reward priorities when it comes to sponsors and CRO's investing in their own long term interests versus responding to their most immediate needs of filling their current trials with their existing network of investigators.
It would take at least a year or two to fully train an Investigator to not only understand the nuances of adhering to GCP guidelines and the like, but also to fully grasp the intricacies of managing their new business to the point of profitability. In most cases, this 1-2 year training window would not directly benefit the CRO or Sponsor whose undertaking it was to recruit and train the physician and might also backfire if the investigator is not prepared to fully commit to the strenuous (and probably unpaid) training period. It also might help a competing sponsor or CRO if this investigator would also begin to conduct studies for those companies that had no risk or expense in training the physician.
I still believe that the long term benefits of this strategy would outweigh the short term risks. In fact, putting my money where my mouth is, my own startup CRO operates on this exact same thesis. Through our consulting firm we have already seen dozens of research naive physicians open their own research clinics and reach profitability within 2 (sometimes even 1) year. While we are doing this on a small scale, I invite my colleagues to consider taking advantage of being the "first mover" in this space. Luckily for you, my CRO can be subcontracted to take care of this physician identification and training task. Here is a video we made to present this thesis of ours in greater detail.
I welcome your thoughts on this research naive physician hypothesis and would love to hear from you.