Project Description

Summary:

International Clinical Trials Day is commemorated worldwide on or around May 20. It was first launched in 2005 by the European Clinical Research Infrastructure Network (ECRIN), in recognition of the day on which James Lind started, what is widely believed to be the first clinical trial, in 1747.

Aboard the HMS Salisbury of the British Royal Navy fleet, Scottish surgeon mate James Lind conducted his “fair test” in search of a treatment for Scurvy, which we now know is caused by a deficiency of Vitamin C, and which is thought to have killed more British sailors than French and Spanish arms.

Although the method of allocation is unknown, in his “controlled trial,” he recruited 12 navy subjects, assigning two each of them to six different potential daily treatments for an equal duration of 14 days. Crucially, due attention was given to controlling potential confounding factors and minimizing bias, both of which are essential in well-designed clinical trials.

A clinical trial, is thus, distinct from observational or epidemiological research. Randomized controlled trials (RCTs) are performed with the objective of investigating a clinical question wherein there is no certain answer as of yet, or in trial terminology, “clinical equipoise.”

They involve a great deal of attention to detail in terms of design, with scrutiny from ethical review boards and regulatory authorities at each phase. International Clinical Trials Day is an opportunity to celebrate the achievements of clinical researchers and research organizations, and indeed to raise awareness of clinical trials as well as the need for randomized evidence among the general public. The Covid-19 pandemic is perhaps the greatest testament to the necessity for good randomized evidence in informing clinical practice. While some high-income countries also struggle with implementing well-designed clinical trials owing to a variety of reasons, in the context of Bangladesh, there is an urgent and dire need to introduce the concept of this distinct methodology of research into the medical landscape.

Full-text link: https://www.dhakatribune.com/opinion/op-ed/247178/op-ed-what-are-our-opportunities-in-clinical

Keywords: Clinical trials, Bangladesh, Randomized controlled trial, RCT, Ethical review, Bangladesh medical landscape