What is Clinical Research?
TL;DR
Clinical research is the process by which new treatments and medical devices are studied and validated before reaching patients. Spanning pre-clinical discovery, clinical trials, and post-market monitoring, it is a globally conducted, heavily regulated field that draws on expertise from science, business, technology, and beyond. While its core purpose to improve human health has never changed, the field is evolving rapidly. Clinical research stands at a critical inflection point, and how it rises to meet these challenges will shape the future of medicine for generations to come.
What it Takes to Have a Medical Breakthrough
Clinical research is the backbone of modern medicine, yet most people only encounter it as a footnote on a prescription insert or a passing commercial break about a new drug approval. The truth is that behind every treatment available to patients today is a long, complex, and carefully regulated journey from scientific discovery to clinical application. That journey doesn’t happen in a single lab or within the walls of one company. It spans continents, disciplines, and decades — and it has been happening longer than most people realize.
King Nebuchadnezzar, ruler of Babylon, is credited with conducting one of the first uncontrolled clinical trials, as documented in the biblical Book of Daniel. In the passage, the King believed that a diet of meat and wine would keep his men strong and fit for battle. Other men preferred a vegetarian diet, and the king allowed them to follow a diet of legumes and water for 10 days. The trial concluded that the vegetarian men were better nourished, and so the king permitted them to continue their preferred diet. It was an early example of comparing treatments and observing outcomes, which remains the fundamental premise of clinical research today.
That premise now drives an industry spanning continents, disciplines, and decades, driven by a shared goal of improving human health. Understanding how clinical research works, who is involved, and where it is headed matters not just for those working in the field, but for anyone who will one day benefit from its outcomes. And at some point, that includes all of us.
It Spans Academia and Industry
To some, clinical research may paint a picture of scientists in sterile labs — and while this is true, it is not the complete picture. Clinical research can be broken into pre-clinical, clinical, and post-clinical stages.
During the pre-clinical stage, the real science and discovery take place. A new compound may have been discovered, a new technology invented, or an existing drug is believed to be repurposed. Scientists are the driving force at this stage, conducting bench experiments often with human cells and/or small animals depending on the treatment. If found safe and efficacious, many hurdles must still be cleared — including countless regulatory and financial requirements — before the therapeutic can be tested on humans.
The clinical stage is what most people are familiar with — a phase that media loves to use for sci-fi films. Broadly broken into phases 1–3, the clinical phase is the process of conducting controlled research on a patient population to ensure the therapeutic is performing as intended and is safe to administer (this is a simplification, but you get the gist). Given the scrutiny of this stage, past mistakes have created patient distrust around clinical trials. Other posts will cover this in more detail, but it’s worth noting that significant progress and awareness efforts are currently underway to ensure fair and honest clinical trials are conducted worldwide. The clinical stage is commonly conducted by pharmaceutical companies that finance the trials (including some biotechnology companies); hospital systems and universities may also serve as sponsors — the term for the organization conducting the trial.
The post-clinical phase occurs after a therapy is approved and available on the market. Some treatments are monitored for years, even decades, to track differences across patient populations, side effects, or outcomes over time. The clinical trial sponsor is responsible for conducting this stage.
It is a Global Field
Science is a universal language — it does not change based on location and holds constant across cultures. It is common for scientists to collaborate across the globe to verify findings, compare their work, and refine treatments for the greatest positive impact on patients’ lives. While each treatment is rarely available globally right away, clinical trials are often conducted in multiple countries and encompass diverse patient demographics. This is done to investigate any differences across patient groups.
Multiple Stakeholders Working Together
Clinical research is a large field with multiple stakeholders driving and supporting its execution. Teams spanning science, academia, regulatory affairs, pharmaceuticals, events, marketing, business, design, technology, travel, and many other industries work together to ensure trials are successful. While many of these roles can be filled by people with varied backgrounds, I encourage those interested to research specific positions further.
Shifting Trends Across the Board
Clinical research sits at a fascinating and critical inflection point. The tools available today — AI-driven trial design, decentralized studies, real-world evidence collection — hold the promise of making trials faster, cheaper, and more inclusive than ever before. Yet technology alone is not enough. Rebuilding patient trust, closing diversity gaps in trial participation, and navigating an increasingly complex global regulatory landscape remain some of the field’s most pressing challenges. The science is advancing rapidly; the question is whether the systems, policies, and culture surrounding it can keep pace.
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