The Evolution of CROs: Some Will Innovate Others Will Become Irrelevant
Hello everyone,
Welcome back to another edition of "Investigator's Brochure." Today, we’re diving into a hot topic in the clinical research community: the evolving role of contract research organizations (CROs). Are these changes pushing the industry forward or disrupting the established norms we've relied on for so long? Maybe a bit of both?
Let's start with technology. We're witnessing a seismic shift as advanced data analytics
However, here's the catch: are we becoming overly reliant on these technological marvels? As this technology becomes ubiquitous and some of the core competencies of CROs (and even sites) are disrupted, we must remember that the heart of clinical research has always been its human touch. The meticulous care, deep understanding of patient and site nuances, and motivational soft skills required to influence site behavior are crucial. By handing over so much to machines, are we risking the very essence of what makes clinical trials trustworthy and reliable? Will CROs be able to adapt? What about those working within these organizations?
Another significant change is the shift towards patient-centric approaches
I have personally been involved in a trial that failed miserably due to glitchy ePROs and a patient user experience that was clearly not well thought through. In an era where patient and site voices are louder and more influential, and sites hold significant leverage as gatekeepers for patient study participation, CROs (and tech vendors) need to appear more site-friendly. Enter the era of Site-Centricity! But is this genuine care or a calculated move to continue winning sponsor market share?
The answer, in my opinion, is illustrated by the rising trend of CROs and private equity acquiring site networks. Traditionally, CROs offered a suite of services to pharmaceutical companies while "overseeing" sites, but now they're buying up site networks to control more of the clinical trial process. This vertical integration could streamline operations and reduce costs, but it also raises potential conflicts of interest and questions about the impartiality of trial results. Are CROs overstepping their bounds by owning the sites where trials are conducted? Don't even get me started on large central IRBs owning sites!
The core competency of CROs is also shifting. No longer are they just service providers; they're becoming strategic partners, leveraging their expanded capabilities to influence study design and execution from start to finish. They are gradually becoming the tech vendors themselves, just look at IQVIAs recent site friendly single sign on for all study portals in their ecosystem. This shift can lead to more efficient trials, but it also means CROs wield more power and control than ever before. Are we comfortable with this concentration of influence in an industry that hinges on objectivity and unbiased results?
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Speaking of regulations, the FDA and EMA are racing to update their guidelines to keep pace with these rapid advancements and encourage increased diversity among trial participants. CROs must constantly adapt, investing in new tools and training their staff to comply with evolving standards. While tech vendors historically innovate faster and depend on collaborations and open-source paradigms, CROs have no interest in playing nicely with the competition. They prefer to innovate slower and build products in their walled gardens, using their expertise to stifle innovation for the sake of sites and patients in order to increase further market share and dominance.
So, where does this leave us? The role of CROs is undeniably evolving, driven by technological advancements, site and patient-centric approaches, the rise of the powerful site networks, decentralized trials, and regulatory changes. But this evolution is fraught with challenges. As we venture into this new era, we must critically assess whether these changes are truly beneficial or if they’re creating new issues while solving old ones. Site networks powered by a layer of technology and basic CRO services may very well evolve into what CROs should have become. Time will tell.
I want to hear from you. What are your thoughts on the evolution of CROs? Are these changes genuine innovations or just disruptive forces? Let’s engage in a lively discussion.
Until next time, stay informed and stay critical.
This article was based on a recent video I did on this same topic which you can watch here:
Hi Dan, good article and I liked the video, as Yuma is my hometown and I recognize much of the scenery. For years we've known that you can't do a clinical trial without investigators and patients, that is - sites. For too long, the burden on sites was not seriously addressed. Seeing sites getting, gaining or demanding more say in the efficient running of trials is encouraging. Part of the slow adoption of edc by CROs was they saw a loss of revenue from no longer having employees doing double data entry. They knew edc was a better, more efficient way to do so, but they had quarterly financial results to hit for their executives' financial compensation. We're seeing this with Risk-Based Monitoring - FDA is good with it, encourages it, there are good tools to support this; however, CROs make significant revenue from regular visits to sites by CRAs. Irregularity of sites visits makes financial projections difficult. CROs implementing RBQM need to revise their pricing models. I am hopeful that AI, ML, NLP advances will be adopted much faster than the ~10 years it took for edc to become established.
US Director | Data Protection Officer @ MyData-TRUST | Licensed Attorney, CIPM, CIPP/E, CIPP/US
8 个月Great article Dan Sfera! Thank you for reminding us that the "heart of clinical research has always been its human touch." If we can leverage the promise of AI to optimize data and efficiencies, while ALSO creating new opportunities for personalized, patient-centric engagement, then that's a win-win. Navigating this paradox will continue to be one of industry's biggest challenges moving forward.
Pharmaceutical Executive | Clinical Development | Contract Management | Metrics & Analysis | Site & Patient Solutions |Study Start-up| Risk and Change Management | Team Development | Applies impactful clinical strategies
8 个月Interesting article
Chief Commercial Officer specializing in New Business Development and Key Account Management at Kapadi
9 个月Hey Dan, great article. No doubt, the times are changing. I would challenge that the influx of data, and CROs partnering (owning) sites actually streamlines the feasibility process as they are familiar with site burden and patient access. (Feel free to write your next on that topic) Regardless, I definitely agree with the points about large CRO's owning the end to end process. It definitely removes any governance. And I COMPLETELY agree about a certain IRB owning everything....(another topic for another time) Keep up the good content and discussions.
Clinical Business Development Executive, 1to1 customer focused leader, 15 year stroke survivor, patient advocate!
9 个月Just saying.. my esteemed patient recruitment colleagues were talking about “patient first” needs 24 years ago when I started in clinical research. I think finally people are listening but it’s more confusing than ever .. look at the exhibit hall this past spring at SCOPE… everyone hangs up a sign now with the fahionable buzz words.