Last month, the Diabetic Retinopathy Collaborative Research Network (DRCR.net)1 met for their annual winter meeting in Orlando, Florida. The DRCR.net is a network of retina specialists who have come together to provide their collective efforts to conduct clinical research in diabetic retinopathy: the leading cause of blindness in the U.S.
By combining the effort of over 300 clinical research sites and their respective patient populations, the DRCR.net has access to one of the largest and most diverse patient pools in the world. Because it is funded in part by the National Eye Institute, the results of their research are freely accessible to the public.
But the one thing this research network has fought to maintain was autonomy in what it research it conducts and how it collects and interprets the data. This is an incredibly important detail.
The DRCR, a clinical research network, was credited with showing that the lower costing and off-label Avastin ($60) was comparable to higher costing Lucentis and Eylea (both ~$1800) to treat diabetic macular edema, a vision threatening complication of diabetes, when followed for 2 years.
This year, Dan Martin, M.D, the Chairman of Ophthalmology at the Cole Eye Institute in Cleveland, Ohio, and one of the directors of a different clinical research network who conducted the all-important CATT trial2 was the invited speaker and addressed the audience.
“Virtually all successful new treatments will require pharmaceutical company partnership.”
He’s correct. These days, clinical research is driven by pharmaceutical companies who risk an incredible amount of time and financial resources to support medical research all the way from conception of the new drug through the completion of numerous rigorous clinical trials in order to demonstrate that the a drug is both safe to use and can help treat disease.
This can take nearly a decade and cost hundreds of millions of dollars. In this day and age, Big Pharma companies are the only ones comfortable enough to foot the bill with hopes of finding the next Viagra or Zoloft.
However, once these medications are FDA approved and out in the market, it’s up to physicians to figure out what’s the best drug out there for our patients. For many health conditions, there are often multiple options to treat patients.
Some are the newest (and often) and the most expensive drug, but some are decades old that still work well and maybe available for a fraction of the cost. Other treatments may be effective, but only available off-label.
How do you know which is better?
As we learn more about the underlying causes for a disease, we might find that an older drug or a new compound may work for a condition that doesn’t already have a great treatment.
It might work anecdotally in a patient or two, but how do we study it in a larger cohort to validate the findings?
In most cases, Big Pharma wouldn’t be interested in conducting this experiment on its own. And why should they? They’ve already spent hundreds of millions to get their drug through the rigorous scientific phase.
It would be reasonable for them to sit back and reap the profits rather than pour money into another study.
That’s where physician led clinical research networks like the DRCR.net and the CATT trial are important. These groups can provide the patients, the structure and resources to frame clinical trials to ask the questions that remain to be answered.
Since the protocols are developed by the physicians, and not the pharmaceutical companies, they are free to ask bold questions without regard for stockholder approval.
Since they control their data, they aren’t afraid of publishing data both good and bad.
They want to discover which treatment might be better, which is more cost-effective, which may be more harmful, and most importantly, to provide guidance to the medical community that might lead to a change in management for the better.
They’re free to find new treatments for patients because that’s what they want to do.
Big Pharma-sponsored clinical trials are important to bring new drugs to our patients. But Clinical Trial Networks are the entities that can help figure out how we actually practice medicine.
1Disclosure: Since 2007, I have served as an investigator participating in research with the DRCR.net. That said, any opinions discussed in this blog post are entirely my own and do not necessarily reflect those of the network.
2Comparison of Age-Related Macular Degeneration Treatment Trial – a physician led clinical research network trial that showed the world that the low cost $60 per injection Avastin was not inferior to the the high cost, $1800 per injection Lucentis, for wet macular degeneration. To this day, the impact of this trial with regards to cost-effectiveness, safety, ethics, government and health policy changes continue to be relevant. The Harvard Business Review had a field day.