Clinical trials are the cornerstone of medical progress

In 1747, Scottish physician Dr. James Lind conducted an experiment aboard a British naval vessel to find a cure for scurvy, then a devastating cause of illness and death among sailors. He divided 12 afflicted sailors into six groups and administered different remedies such as cider, vinegar, seawater, spice paste, and citrus fruits. Within a week, the group receiving oranges and lemons recovered and returned to duty, while the others showed little improvement.

Lind’s experiment, now recognized as the first controlled clinical trial in history, generated crucial evidence that citrus fruits prevented and cured scurvy. More importantly, his methodology marked a breakthrough in medical research and laid the groundwork for modern clinical trials.

A clinical trial is a research study involving human participants to evaluate the safety, efficacy, and broader effects of an intervention, whether a medicine, vaccine, medical device, behavioral change, or new standard of care. Clinical trials are indispensable to the research-based pharmaceutical industry’s drug development process. They ensure that innovation is rooted in rigor, safety, and efficacy before new therapies reach the market. They also provide healthcare professionals with the scientific evidence needed to care for patients and improve quality of life.

The global response to COVID-19 powerfully demonstrated the value of clinical trials. When the pandemic hit, the biopharmaceutical industry worked with governments, regulators, and scientific institutions at unprecedented speed and scale. New and repurposed treatments were tested, and vaccines were developed on groundbreaking technological platforms, deployed, and continuously monitored that were all enabled by clinical trials that were rapidly launched in the face of uncertainty.

National Regulatory Authorities (NRAs) played a pivotal role.

To overcome the exceptional challenges of the pandemic, regulators adopted a range of flexibilities and innovations in clinical trial processes. Some approaches were new, while others were accelerated from pre-existing tools, including the digitalization of trial conduct, remote monitoring, and decentralized trial models. These adaptations not only advanced the global COVID-19 response, but also offered lasting insights into how clinical trials could evolve to better integrate science, regulatory agility, and patient needs.

Data sharing has likewise emerged as a key enabler of scientific progress. Responsible clinical trial data sharing expands scientific understanding, improves patient outcomes, reduces duplicative research, and fosters public trust. The biopharmaceutical industry seeks to enhance public health through data sharing that is grounded in three principles: safeguarding patient privacy; upholding the integrity of NRAs; and sustaining investment in biomedical research and innovation.

The momentum for reform continues. In September 2025, 11 major global medical research funding bodies signed a joint statement supporting World Health Organization (WHO) standards to strengthen clinical trial systems. The signatories are committed to improving trial design, ensuring representative trial populations, integrating clinical trials into sustainable national infrastructure, and embedding best practices in transparency, data management, and public engagement.

Building clinical trial capacity also relies on regulatory convergence and harmonization. Encouraging reliance and work-sharing among NRAs can accelerate patient access to new therapies, reduce fragmentation, and promote evidence-based decision-making. Patient engagement and responsible data sharing are equally vital in building trust, supporting transparency, and ensuring that innovation translates into public health impact.

Another critical dimension is diversity and inclusion in clinical trials. Patient populations should reflect the epidemiology and demographics of those who stand to benefit from new treatments. Diverse participation is both a matter of equity and scientific rigor. It helps determine the right treatment for the right patient. The biopharmaceutical industry is committed to advancing diversity in clinical research and ensuring equal opportunity to participate in relevant trials.

Transparency also remains a cornerstone of accountability and public trust. Biopharmaceutical companies routinely collaborate with academic researchers, publish clinical research, and share trial information at recruitment, completion, and, depending on applicable rules, post-approval or program discontinuation. Increasingly, efforts are underway to provide lay summaries of clinical trial results so that research participants can better understand the studies in which they took part.

Clinical trials are thus more than a procedural step in drug development. They are the engine of medical progress. They generate the evidence needed to develop innovative medicines and vaccines that save and improve lives. As the world continues to invest in science, data, and regulatory modernization, we reiterate our commitment to transparency, ethical and regulatory compliance, and enhancing diversity in clinical trials. Ultimately, strengthening clinical trial systems is an investment in public health, innovation, and patients worldwide.