The question of which treatment targets are best remains unclear but is important to decipher, according to Dr. Colombel, who said simple studies comparing outcomes when patients are treated to symptoms vs. treated to biomarker measurements are needed. Whether to treat to certain medication trough levels vs. symptom relief is also a pressing need, as well as is the importance of mucosal healing vs. symptoms. “This is important because there is discordance between endoscopy and histology,” said Dr. Colombel. “Persistent histologic inflammation is frequently associated with bad outcomes.”
However, endoscopic scoring itself is another area Dr. Colombel said is worth investigating, especially when it comes to validating endpoints such as those in the Crohn’s Disease Index of Severity (CDEIS), and Simple Endoscopic Score for Crohn’s Disease (SES-CD), which will help determine remission cut offs. Also, using endoscopic scores in comparison with live video and imaging still need standardized approaches. “When you see how it is done in the U.S., it is generally very poor,” Dr. Colombel said.
The biggest obstacles of all when it comes to independent investigation in the United States, according to Frenchman Dr. Colombel, is heavy regulation and cost. “In France, [conducting trials] was considered part of my job. I was not compensated. It is different here.”
Despite that, he said successful studies are a matter of desire. “You have to have dedicated people who want to run these studies and who can meet often and drive the process, and be ready to recruit patients.”
Dr. Colombel has numerous financial ties to the pharmaceutical industry, including AB Science, Amgen, Baxter, Bristol-Meyers Squibb, Merck, Nutrition Science Partners, Teva, and Vertex, among several others.
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