The Seasons of Clinical Research | November 2024

The Seasons of Clinical Research

At first glance, it might seem like clinical research is immune to seasonality. But for those of us who have worked in this industry for a while, we know that clinical research has its own rhythms—its seasons. I was reminded of this when I saw Christmas decorations already in stores, even though it feels like April was just yesterday.

On the service vendor side of the industry—Contract Research Organizations (CROs)—time seems to move differently. It’s often said that one month of intense activity, like closing a database, can feel like “dog years” aging all those involved by 6 months or more

So, let’s talk about the tempo of clinical research.

The Industry Barometer: JP Morgan

A key indicator of the industry’s health is the buzz surrounding the JP Morgan BioPharma Conference in January. For 2024, it felt like a return to the “good old days,” with investors actively committing—or at least appearing to commit—funds. However, the optimism of Q1 was quickly dampened in Q2, as global uncertainty left investors cautious.

The Marathon from January to June

In January, the industry shakes off the cobwebs of the holidays, slowly waking from its collective hibernation. By February, clinical trial plans are being firmed up, RFPs (Requests for Proposal) are flying around, and the flurry of activity builds. Projects get committed, vendors/partners are chosen and projects get underway.  Companies put their efforts into hitting key regulatory milestones. With budgets finalized and strategic plans set, the race begins to align teams, manage stakeholders, and ensure compliance.

The first half of the year is packed with industry conferences, like JP Morgan, SCOPE, BIO and DIA. Like any marathon, this period demands endurance, focus, and meticulous planning. Hitting mid-year targets is essential for setting the tone for the rest of the year, making this stretch one of the most challenging—and rewarding—phases in clinical research.

Summer brings a different pace. While clinical research itself doesn’t take a vacation, people working in pharma, biotech, and med devices do. The industry hums along as awarded projects are being managed, but new project awards slow significantly. Then comes September, when everyone is back on deck, and the intensity resumes at full throttle.

The fourth quarter is a unique challenge known as the “sprint”. While pharma and biotech teams wind down for the holidays, those involved in starting up clinical sites and enrolling patients feel the pressure. Often, there’s a mad dash to get even one patient enrolled before the year ends—a milestone frequently tied to promises made to investors or boards.  The rush to enroll just one patient before year-end often comes down to pressure from boards or investors. You can almost picture the scene: a founder, under scrutiny from venture capitalists, standing tall and declaring, “We’ll enroll our first patient into this critical trial before the year is over!” Despite unforeseen obstacles—protocol amendments, investigator feedback, or new testing requirements—they feel compelled to stick to the timeline. This pressure underscores how arbitrary deadlines can sometimes overshadow practical realities in clinical research.

Closing Thoughts

Looking ahead to 2025, there’s growing optimism. While challenges like geopolitical conflicts, unemployment, and inflation remain, the end of the U.S. election cycle could bring some stability. For now, this is the time to stretch our muscles, refine our strategies, and prepare for what promises to be a busy and successful year ahead.

Clinical research, much like the seasons, has its cycles of growth, pause, and renewal. From the frenzy of Q1 to the reflective planning for the year ahead, each phase brings its own challenges and opportunities. With the promise of a brighter 2025, now is the time for the industry to push forward and embrace the next wave of innovation.

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