International Clinical Trials Day: From James Lind's First Trial to Modern Medicine

By Devyani Patil, Pharm D

International Clinical Trials Day, observed globally on May 20, commemorates the birth of modern clinical trials. The overarching theme for 2025 is “Rethinking Clinical Trials: Inclusivity in Practice.” This theme, led by the European Clinical Research Infrastructure Network (ECRIN) and co-hosted with the Spanish Clinical Research Network (SCReN), emphasizes the importance of diversity, equity, and inclusion in clinical research. It’s a day to recognize not only the participants and researchers but also the regulatory bodies like the FDA, whose oversight ensures ethical, safe, and effective studies. Despite progress, many medical challenges remain, requiring innovation, dedication, and global collaboration. Clinical trials have evolved significantly since the era of James Lind, not just in terms of medical, scientific, and technological progress, but also in ethical and legal standards. Nevertheless, clinical trials continue to be a vital component of drug development, serving as a means to produce evidence that aids in regulatory decision-making to ensure the safety and efficacy of new medications.

The history of clinical trials is lengthy and evolutionary. It spans a wide range of issues, including scientific, ethical, and regulatory aspects. James Lind is regarded as the first modern-day doctor to perform a controlled clinical experiment. As a shipboard surgeon, Dr. James Lind (1716–94) was horrified by the high scurvy mortality rate among sailors. He organized a comparison study of the most promising scurvy treatments. The key components of a controlled trial are covered in his detailed account of the trial. In May 1747, Dr. James Lind conducted the first controlled clinical trial in history aboard the Salisbury. He selected twelve patients suffering from scurvy with similar symptoms and divided them into six groups. Each group received a different treatment: vinegar, seawater, citrus fruits (lemons and oranges), cider, vitriol elixir, or a surgeon's tonic. The group receiving citrus displayed remarkable recovery within just six days; one patient was able to resume duty, while the other improved enough to assist in caring for others. This groundbreaking 1747 experiment laid the foundation for modern clinical research.

The foremost concern of this industry is the regulatory framework for trials involving human subjects. The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This act tasked the commission with pinpointing the fundamental ethical principles that should guide the conduct of biomedical and behavioral research involving human participants, as well as creating guidelines for ethical research practices. The Belmont Report, produced in 1978, was the outcome of this effort. Building on these principles, other global ethical frameworks such as the Declaration of Helsinki and the latest ICH GCP E6 R3 guidelines, which aim to modernize Good Clinical Practice by emphasizing data integrity, risk-based approaches, and patient involvement, further ensure participant protection.

Conducting clinical trials in vulnerable populations, including low-literacy and poorly resourced environments, presents significant ethical challenges that require immediate attention. Informed consent—the fundamental principle of ethical research—loses its importance when participants are unable to read, understand, and process complex medical information or grasp the risks involved due to language barriers and limited education. This results in an imbalanced power dynamic, where vulnerable individuals may “consent” to participate without genuinely comprehending what they have agreed to, making their consent more of an illusion than a true voluntary decision.

Even more concerning is the potential for economic coercion within impoverished communities. When clinical trials provide financial compensation, free medical care, or other incentives, it is often desperation, not true willingness, that motivates participation. This transforms clinical research into a process of exploitation, with those less fortunate taking on risks for advancements that mainly serve wealthier groups.

One example of the real-world consequences of ethical failures is the Pfizer Trovan tragedy. In 1996, during a meningitis outbreak in Nigeria, Pfizer carried out a controversial trial of its experimental antibiotic Trovan on severely ill children, failing to secure proper voluntary informed consent from their families. Many parents, in desperate circumstances and often unable to comprehend English, did not fully realize they were enrolling their children in a medical experiment instead of receiving established treatment. Sadly, 11 children lost their lives, and numerous others experienced lasting disabilities such as deafness and brain damage. This remains one of the most shocking instances of ethical breaches in modern medicine, where a vulnerable population in distress was taken advantage of for drug testing without sufficient protections or transparency.
This incident emphasizes the essential requirement for strict regulations in Informed Consent Procedures (ICF) and ethical monitoring to safeguard participants in clinical studies, particularly within at-risk communities.

Insights from the Field While advancements in ethical regulations and technology have improved clinical trials, patient apprehensions remain a significant barrier to participation.

Dr. Theresa Lily Thomas, BDS, of MedBound Times connected with Anjaly Maria Jose, M. Pharm, NIPER, a Consultant in Patient-Centered Research, and she highlighted the most common concerns patients have and how these are best addressed:

1. Safety and Side Effects

Patients often fear unknown side effects or receiving less effective treatments. Addressing this begins with transparent communication—explaining risks in plain language, detailing safety monitoring, and reassuring participants they can withdraw at any time.

2. Fear of Being a “Guinea Pig”

Clinical trials are sometimes seen as experimental and unsafe. This misconception can be countered by emphasizing the rigorous scientific and ethical standards followed, including oversight by ethics committees, use of placebos, and success stories from past trials.

3. Time Commitment and Logistical Burdens

Long travel times, missed work, and extended waiting periods are common concerns. Flexible scheduling, telemedicine, and offering reimbursements or on-site amenities (food, entertainment, childcare) can make participation more feasible.

4. Lack of Understanding

Patients may not grasp the trial’s purpose or process. Using lay-friendly visuals, repeat explanations, and designated staff for Q&A fosters better understanding and trust.

5. Access to Standard Care

Some worry about losing access to proven treatments. It’s critical to clarify that participants receive either standard care or a potentially better option, always under close medical supervision.

6. Confidentiality and Data Privacy

Assurances about how data is anonymized and protected under regulations like HIPAA help alleviate fears about personal health information security.

These insights highlight the importance of patient-centric communication and infrastructure in improving recruitment and retention in clinical research.

The clinical research sector is consistently evolving, allowing researchers to create new drugs and approaches to combat and prevent illness using various technologies. As we approach mid-2025, groundbreaking trends like AI, decentralized trials, and real-world evidence are reshaping clinical research.

Recently, clinical trials have been revolutionized globally, shaped by various aspects including decentralized trials, the involvement of AI and machine learning, patient-centric approaches, real-world evidence (RWE), telemedicine, remote monitoring, and advanced therapies, along with adaptive clinical trials. These are all playing a crucial role in transforming the field of clinical research.

These developments not only enhance the efficiency and accessibility of clinical trials but also pave the way for more individualized and effective therapies in the future.

As these trends evolve, we can expect remarkable breakthroughs that will improve patient care and outcomes worldwide.

International Clinical Trials Day is a tribute to centuries of progress driven by science, ethics, and the unwavering commitment of patients and researchers alike. As clinical trials continue to evolve with cutting-edge technologies and human-centered approaches, their role in shaping the future of healthcare has never been more vital.

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5. Tenti, Sara, Elena Poggi, Gianluca Baiguini, Michele Usuelli, and Marco Massari. "Patient Participation and Involvement in the Evaluation of Technologies: A Scoping Review of the Literature." BMJ Open 9, no. 4 (2019): e026735. https://bmjopen.bmj.com/content/9/4/e026735.

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8. U.S. Department of Health & Human Services (HHS). "HIPAA Privacy Rule." Accessed May 19, 2025. https://www.hhs.gov/hipaa/index.html.

9. Clinical Trials Transformation Initiative (CTTI). Decentralized Clinical Trials Recommendations. 2022. https://www.ctti-clinicaltrials.org.

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