May 20th. The day the first pair of shoes were designed, in 1310. The day bona fide, national treasure Louis Theroux was born, in 1970. And, most excitingly of all, the day James Lind conducted the first randomised clinical trial, way back in 1747. Thanks to James, May 20th is now also World Clinical Trials Day.
James Lind was a Doctor, pioneer of naval hygiene and an expert on the treatment of scurvy. In 1747, while serving as surgeon on HMS Salisbury, he selected 12 men with scurvy, to take part. Lind divided them into pairs and gave each group different additions to their basic diet, including cider, garlic and citrus fruits. Those fed the citrus fruits experienced a remarkable recovery. Lind’s research had established their superiority, over other remedies, and his findings subsequently led to scurvy almost completely disappearing from the Royal Navy. Not a bad result from the first randomised clinical trial.
It did get us thinking, though. Would Lind’s clinical trial stand up to today’s rigorous standards? Let’s examine his methods.
1. Clinical trial protocol. Even if Lind had carefully considered whether his study should be double-blind, placebo-controlled or open-label – we highly doubt he formalised it in a peer reviewed clinical protocol. Poor form, James. Poor form.
2. Ethics. The 18th century wasn’t renowned for its exemplary ethics, so we doubt James obtained the approval of an ethical committee before conducting his research. If he had, we suspect they would have insisted on additional blood draws, using leeches, and increased rum consumption, in the name of participant safety.
3. Informed consent. Did James subject his participants to a 25 page ICF, highlighting the risks of terrible morning breath following ingestion of the garlic, or the desire to wash the lime down with a liberally-poured G&T? We can only hope so.
So although Lind’s trial might not be ship-shape* by today’s standards, we have a lot to thank him for. His research led to the birth of clinical trials and the subsequent development of many life changing medications.
Happy #CTD2019 to everyone involved in clinical trials. Remember to toast James and thank him for a scurvy-free day.
*Sorry. Couldn’t resist.