Digital technology changes clinical trials

Big pharmas have established themselves as manipulators of small molecules, moved along to biologics and then began to invest billions of dollars into fields like gene therapy. Contract service providers used to simply run clinical trials in many cases. Now, as they continue to do that, they are expanding their operations in both in size and function. Regulators, who used to keep their distance from industry, are now amenable to collaboration. While drug development is evolving quickly, there is still much to achieve in clinical trials, especially to make them “more reflective of and helpful to patient needs,” according to an article by Jacob Bell in Biopharma Dive.


Bell interviewed Barbara Kunz, global chief executive of the Drug Information Association, who said, “We are in the era of dramatic transformational change in health, both in product development but also at the system level with the way those products are regulated, the way those products are being discovered and developed, the integration of patients into their healthcare, and the value frameworks on the market access side of healthcare.”


“Digital” and “patient” are the two words Kunz is hearing most. As she explained, “They're kind of the same, because people know that to get patients involved, you need to figure out how to give them information and get their information in a way that they don't have to get in the car and sit in somebody's office for hours.”


Kunz thinks that people are excited about the “digitization of healthcare and the ability to use data all the way from early discovery to in-use, including EHR [electronic health record] data.” She also cited “patient engagement in their healthcare” as a major trend.


As to artificial intelligence (AI), Kunz thinks that people are experimenting with opportunities and seeing results of AI is being used for things like label expansions. As she explained, “You're finding these technologies are no longer this big scary thing people can't think about conceptually. People now are getting it and are starting to work collaboratively with some of the new or big technology companies.”


She added, “Most of the time you're a victim of your circumstance. If you're sitting in a part of the world where you have access to some level of health care, good or bad or none, you take what's available to you. But when everything's digitized ... you can at least go into a portal, perhaps in an ideal state, and say, ‘Well, I just found out I have this illness, let me go on there and read a little bit about how I might deal with it.’ You could find out if the preventative measures are things you can do that are simple. Or, if it's this very significant health challenge, where are the best places to get involved in a therapeutic regimen or a clinical trial?”


When asked what part of drug development she perceives as the most in need of change right now and why, Kunz said “I think the clinical trial part. It's not only the one that is most expensive; it's the one patients find most confounding.”



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