Swashbuckling through data in clinical trials

Published: 8 Months agoArticle

We tend to think of the use of data in healthcare as a modern phenomenon, so we thought it would be interesting to go back in time to the 1740s, with the origins of the first clinical trial - where naval physician James Lind looked to tackle scurvy. Modern clinical trials seem far removed from this initial attempt....

On 15 June 1744 Commodore George Anson’s flagship Centurion emerged from the dense fog of the English Channel and drifted into the busy waters at Spithead. Four years earlier Anson was ordered to disrupt the Spanish forces in the recently colonized America, and despite a number of successes, this journey was infamous for the horrific loss of life, not caused by combat, but due to disease. Out of an original crew of 1,854 over the four-year journey, 1,666 sailors had been killed by scurvy[1]. Britain’s naval dominance was under threat and the greatest enemy did not fire a musket or wield a cutlass.

In the 1740s, scurvy was believed to kill more English sailors than both the French and Spanish combined, and the British government, worried by the cost of losing ships, set up a permanent department referred to as ‘The Sick and Hurt Board’ to maintain the health of sailors while at sea[2].  There was no shortage of proposed cures for scurvy, but it wasn’t until a naval physician called James Lind compared these remedies under controlled conditions that a treatment was identified. 

Lind assigned two sickly sailors into one of six groups, he provided the same diet to each sailor, varying only one addition daily supplement; a quart of cider, 25 drops of sulphuric acid, six spoonsful of vinegar, a pint of seawater, two oranges and a lemon, or a paste made of spices.  The two sailors given citrus fruit showed a dramatic improvement and despite running out of fruit on the sixth day of treatment, one of the sailors was already able to resume his duties[3].

Although it would take another 200 years to understand that scurvy was caused by a deficiency of vitamin C, Lind’s systematic documentation of clinical intervention is widely acknowledged to be the first clinical trial.

Modern clinical trials seem far removed from this initial crude attempt, but this paved the way for determining effective medication. 

As science begins to understand medical diseases in greater detail, the methodology of clinical trials used to determine efficacy and safety of new treatments have become more complex. The addition of clinical subgroups where patients are subdivided by genetics, lifestyle, biomarkers or disease progression are able to reveal more nuanced effects based on individual differences. Surrogate markers, self-reported outcomes and traditional clinical outcomes allow for further clinical end points to be analyzed.

Complex, multifaceted diseases such as HIV and cancer require new compounds to be accessed with concomitant medication further increases the complexity of clinical trial design.  The ambition to tackle chronic diseases requiring larger trials involving more subjects over longer periods, and self reported measure such as quality of life presented alongside clinical measures adds to the volume of data collected. The combination of these factors has increased the complexity of both clinical trial design and the reporting of results.

The gigabytes of detailed intricate data that modern clinical trials produce can make results harder to interpret. In James Lind’s original scurvy trial, only two sailors per treatment group were required to demonstrate a clinically significant improvement, but it still took a further 50 years for Lind’s recommendation of citrus fruits to be accepted by the Royal Navy.  If a new modern compound is to be adopted as the standard of care, results of these complex clinical trials need to be presented clearly. 

PharmiWeb Solutions recognizes that increased complexity of clinical trials present new challenges to visualizing clinical trial methodology and results. The use of digital media to present clinical data has revolutionized the way pharmaceutical companies can interact with healthcare providers. Medical information is no longer limited by the linear narrative and passive information transfer permitted by a scientific paper or a conference presentation, modern digital tools allow the user to quickly access relevant information and comprehend the ever more complex data found in modern clinical trials.

Do you have complex medical data you need to present to your audience?  Challenge PharmiWeb Solutions to create bespoke data graphics and visualizations to convey message.

[1] Bown, Stephen R (2003). Scurvy: How a Surgeon, a Mariner, and a Gentleman Solved the Greatest Medical Mystery of the Age of Sail.

[2] P.K. Crimmin (1999) The sick and hurt board and the health of seamen C. 1700–1806, Journal for Maritime Research, 1:1, 48-65, DOI: 10.1080/21533369.1999.9668299

[3] Lind, J (1753). A Treatise of the Scurvy