18.1 clinical trials - history + intro

What is clinical research?

medical research that involves human volunteers to test new treatments, therapies, or interventions.

It aims to gain new knowledge that could lead to improvements in medical care, health policies, or disease prevention.

What are the two main types of clinical studies?

1. Clinical trials (interventional studies) – involve assigning participants to interventions to evaluate their effects.

2. Observational studies – involve monitoring participants without assigning specific treatments.

What was the earliest recorded clinical study?

Bible where young men ate vegetables and drank water for 10 days, compared to others who consumed the king’s meat and wine.

Outcomes were independently assessed, and dietary policy was adjusted based on the results.

this was an uncontrolled experiment: comparing 2 interventions to inform a public health decision

Who was Ambroise Paré and what was his contribution in 1537?

French military surgeon who, lacking oil, used a mixture of egg yolks, rose oil, and turpentine to treat wounds.

He accidentally conducted a comparative experiment, finding better outcomes than the traditional treatment.

What did James Lind demonstrate in 1747?

conducted a controlled experiment on sailors with scurvy, demonstrating that citrus fruits were effective in treating the disease.

This was one of the first recorded clinical trials with multiple groups and comparative treatments.

What was significant about Austin Flint’s study in 1886?

Flint conducted a placebo-controlled trial

What ethical advancement did Walter Reed introduce in 1900?

Walter Reed’s Yellow Fever experiments were among the first to use informed consent, marking a turning point in ethical standards in human experimentation.

Who introduced randomisation into clinical trials?

James Burns Amberson and B.T. McMahon introduced randomisation in 1931 to reduce bias and increase the reliability of results.

What was the significance of the MRC Patulin Trial (1943)?

The Medical Research Council (MRC) conducted a trial on patulin for the common cold.

It was an early example of a large-scale, controlled clinical trial in the UK.

Why was the MRC Streptomycin Trial (1946) important?

first randomized clinical trial for evaluating streptomycin in treating tuberculosis.

It laid the foundation for modern clinical trial design, emphasizing randomisation, control groups, and rigorous methodology.

What are the 7 key concepts that developed over time in clinical research?

1. Control

2. Placebo

3. Informed consent

4. Randomisation

5. Blinding

6. Statistical planning

7. Multicentre trial coordination