This is the first of a series of blogs written in celebration of International Clinical Trials Day 2026. Here we explore the history of clinical trials, where they came from and how they’ve changed.

Clinical trials today are highly regulated and standardised. However, this was not the case until the mid-1900s when the Nuremberg Code was introduced (1947), as well as the Declaration of Helsinki (1964). It was not until the 1990s that the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice (ICH-GCP) guidelines were introduced.

The earliest notion of a clinical trial was in 1747, when James Lind compared various treatments for 12 sailors suffering from scurvy. The sailors were separated into pairs and each pair given a different treatment. One of those treatments, two oranges and a lemon every day, saw a significant improvement in the subjects’ symptoms and condition compared to the rest of the treatments.

The next big jump in trial standards came in 1948, when the UK Medical Research Council published the first Randomised Control Trial (RCT) of its kind, where they evaluated the use of streptomycin for tuberculosis. It was the first RCT due to the short supply of the streptomycin, which meant that it was acceptable to limit the doses given to participants in a random fashion. Patients were randomly assigned to either the treatment group, consisting of the streptomycin and bed rest, or the control group which was bed rest alone. The radiologists evaluating the X-ray scans of the lungs were not told which patient was in which group.

Since the 1940s, the progress in making trials safer and more reliable has been exponential. Various reasons can be attributed to this, such as the Nuremberg Code in 1947 which established some key principles for scientific research which are still in effect today, such as informed consent, reasonable justification for scientific experiments, and a duty to minimise harm done to medical research patients. In the 1950s, there was the Thalidomide tragedy. In 1964, the Declaration of Helsinki was created, which helped usher in new ethical guidelines for medical research such as the idea of independent ethics committees. Then in the 1990s the ICH-GCP was established, standardising the rules and principles behind clinical trials which are still used today, albeit slightly updated.

The reasons for needing standardisation and rigorous ethical guidelines were primarily to protect patients. It also allowed regulators to review foreign trial data quicker and more robustly, since they were confident that trial data obtained abroad met the standards of the international guidelines. Before the international guidelines, trials had vastly different documentation processes, inconsistencies in the monitoring and record keeping throughout the trial, and some trials even differed in their definition of what an adverse event was. The global harmonisation of these standards also meant that companies did not have to repeat studies for different markets, cutting the cost of drug development and making effective drugs more accessible.

These international guidelines, along with regulatory agencies such as the FDA, MHRA, PMDA, and the EMA have helped push pharmaceutical companies to be more rigorous in their approach to patient wellbeing, rather than focussing mainly on the efficacy of their products. Ben Goldacre, a British physician, encouraged pharmaceutical companies to be more transparent and publish not just the trials that were a “success”, but also to publish their data on the trials which did not succeed. He also criticised the pharmaceutical industry for misleading health claims, which has since led to global pharmaceutical companies being more open and transparent with their data.

This shift in attitude amongst “Big Pharma”, and the technological advances in medical treatment has meant that clinical trials, and medical research in general, has become far more patient-centric than it ever was.

However, the data from these clinical trials will still need to be reviewed and monitored. This is where Pharmora can help your company! We provide a wide range of services.

Whether you require some advice on how to set up and get going with a Phase 1 study for your novel therapy, or you require extra resource to review your Phase 3 trial coming up to an interim or final analysis, or even guidance on how to author your Clinical Study Report for submission to regulators. We have decades of experience in the clinical stage of the medical product development process, and we would love to hear about your product and how we could help! For more information, please reach out to us to see how we can provide you with a bespoke service to suit your needs.

We hope you enjoyed this blog from Pharmora Scientist Josh Bryning.

In the next blog, Pharmora Scientist Obimobi reviews the latest updates, and the most impactful reforms to clinical trials regulations the world has seen in centuries.

https://www.gov.uk/government/collections/medicines-clinical-trials

https://www.gov.uk/government/news/launch-of-clinical-trial-reforms