History’s most intense, groundbreaking clinical trials.
In its first 20 years, ClinicalTrials.gov accumulated more than 400,000 registered clinical research studies from around the world. This is to say, simply, there have been a lot of clinical trials.
As time passes, however, we continue to recognize the results of clinical trials but allow the efforts that drove them to fade. We know that polio is not a threat today, but do we remember why?
When we draw the line connecting our progressions in healthcare to the clinical trials that brought us here, a few stand out. Whether it’s from their massive scale, meticulous design, or a profound impact on global health, these are some of history’s most intense and groundbreaking clinical trials.
- A US legacy: the Salk polio vaccine trial.
In the mid-20th century, poliomyelitis, or polio, was one of the most terrifying diseases in the United States, paralyzing thousands of children each year. The clinical trial for Jonas Salk’s polio vaccine in 1954 remains one of the largest and most exceptional medical experiments of its kind.
It was a nationwide effort involving nearly two million children across 44 states. The trial was performed with what were, at the time, newer scientific standards: double blind and placebo controlled. This meant that neither the participants nor the administering doctors knew who received the vaccine and who received a solution with no medication (placebo).
This methodology was essential to provide undeniable proof that the vaccine was effective. The results, announced in 1955, showcased a massive public health victory that virtually eliminated polio in the US, standing as a model for public health mobilization to this day.
- A health revolution: the Women’s Health Initiative.
In 1977, the FDA updated their clinical research guidelines to recommend that individuals of childbearing potential not be included in early drug trials. This is stated to have been based on concerns for potential effects on pregnancy, but the overly general exclusion quickly led to a gaping disparity in women’s health that we still experience today.
It wasn’t until 1990 that this guideline was brought to investigation, and shortly after, Dr. Bernadine Healy became the first female director of the National Institute of Health (NIH) and launched the Women’s Health Initiative (WHI).
The WHI stands as a monumental, long-term effort dedicated to understanding and preventing diseases that are the leading causes of death and disability for postmenopausal women. It was a vast, 15-year program that involved more than 161,000 women across the US.
Multiple large, randomized, controlled trials were encompassed by this initiative. Its most well-known finding came from hormone therapy trials. The data conclusively showed that the widely prescribed use of menopausal hormone therapy for other disease prevention actually increased certain risks. This discovery revised decades of medical thinking overnight, leading doctors worldwide to immediately change how they prescribed hormone therapy and demonstrating the vitality of including everyone in research.
- A global sprint: the COVID-19 vaccine trials.
The clinical trials for the COVID-19 vaccines represent the pinnacle of rapid global research. Launched in 2020, they set a new benchmark for intensity in scale and speed.
With massive global cooperation and advanced technology, researchers around the world launched large-scale, fast-paced trials. This speed and efficiency was achieved through years of foundational work, particularly on the mRNA technology, and by regulatory bodies working in parallel with researchers – reviewing data and preparing manufacturing before final approval.
No safety steps were skipped; instead, the phases of the trials were compressed and overlapped. Because the virus was so widespread, scientists were able to gather necessary efficacy data by comparing infection rates between vaccine and placebo groups much faster than typically possible.
The success of these extraordinary global trials proved the power of scientific focus in a worldwide health crisis. And here at Praxis, we’re proud to have supported recruitment for some of those trials!
These monumental trials demonstrate that the intensity of clinical research, when governed by high scientific and ethical standards, is one of medicine’s most powerful tools for human well-being. Groundbreaking clinical trials like these have fundamentally shaped how we prevent disease, manage chronic conditions, and approach public health, and there are surely many more to come.
If you’re looking for a partner in clinical trial recruitment, let’s connect.
