Deep Thoughts from DIA

Well, I’m not exactly sure how many years it’s been since I attended the DIA Annual Meeting last: certainly at least 2, but in my experience (and not just because of the pandemic), these past few years have been among the most transformational for our industry.?I’m still looking around the house for materials from Annual Meetings in year’s past --- fortunately, I tend to limit my nostalgic / packrat tendencies to a single drawer in my office --- but I’m pretty confident that the comparison I wanted to make of exhibiting companies past and present would indicate that most of this year’s group did not exhibit a few years ago --- if they were in existence altogether!

My takeaway from a walk through the exhibit hall was that pretty much everyone --- CROs, data vendors, technology companies, site networks --- was showcasing their capabilities relating to four (surprisingly interrelated) subjects: diversity, data, DCTs, and RWE.?Everyone is still expressing their perspectives within the context of clinical research and improving patient outcomes, but there certainly are new and exciting approaches that directly address one or more of these four subjects.?(It was also noteworthy that some exhibiting companies on their primary product / service seemed not to realize that their approaches could also (directly or indirectly) be leveraged to positively impact other issues).

It wouldn’t surprise me in the least if, come 2 – 3 years from now, the composition of the exhibit hall changes again fairly dramatically, not necessarily due to more process and technology evolution in clinical research, but rather due to competition and the shaky business models many of these new entrants are built upon.?At the same time, even the tried-and-true CROs will need to rethink some of their revenue / margin projections as well as their service offerings and resource plans, lest they start veering toward the Jurassic.

In terms of the RWE landscape (where I hang out mostly), I wasn’t surprised by its prevalence in exhibitor discourse and in several workshops / presentations: most pharma/biotech companies and their service providers understand and embrace the importance of real-world evidence beyond its “traditional” purpose (of supporting documentation of real-world clinical, economic, and humanistic value).?Indeed, RWD (real-world data) is increasingly being evaluated for use in expediting and enriching clinical development, spurred in part by regulatory acceptance.?And while I’m still not convinced that RWE / RWD is well understood by clinical operations professionals comfortable with processes and expectations appropriate for RCTs, I’m seeing openness to the inevitable onslaught of progress in our industry.?(Yes, the onslaught of progress!)?Indeed, I think this openness is both critical and organizationally healthy.?And maybe driven by the reality that those four subjects --- diversity, data, DCTs, and RWE --- are indeed interrelated and, with creativity and a resolute stand for data quality --- can represent true and simultaneous progress on multiple dimensions.