The method in Clinical Research

It was the year 1747. The Scottish surgeon James Lind was traveling aboard the Royal Navy ship HMS Salisbury, which was patrolling the English Channel. As in any other ship that has sailed long distances before, 8 weeks after leaving, that English ship began to suffer the first cases of scurvy. This was a disease well known to sailors, a disease that causes bleeding, spots on the skin, bleeding gums … a horrible disease that used to end the life of those who suffered it. Nothing new under the sun, since nature used to take that toll on those who dared to sail the vast ocean. The affected sailors had their hours counted, and they knew there was little they could do to turn their luck, but Lind had an idea. He thought that he should do something to save the lives of the sailors and decided to check the effect of different foods on the condition of the sick: Cider, vinegar, sea water, oranges, lemons, etc. He divided the sick into pairs and gave each of them a different treatment. Within days, he saw symptoms of improvement in two of the patients: those who had eaten oranges and lemons. Citrus fruits were the winners, and it is that, as it would be known later, the main cause of the disease is the absence of vitamin C (so abundant in lemons and oranges). But if Lind did not know about vitamins, how did he produce the idea?

Thom, R. A. (1959) James Lind-conqueror of scurvy (painting). Recovered from

Richard Hawkins, a British explorer, already claimed a century and a half before Lind that sour lemons and oranges were a great remedy for fighting scurvy. However, the discovery of the treatment was attribute to Lind, and this is because it was, he who first checked it. The Scottish surgeon used citric to the scientific method, and that is why he was remember.

The fact that there is a definite method when conducting a study is the only thing that allows another doctor, 271 years after the Salisbury sailed through the waters of the Atlantic, to verify Lind’s conclusions. The scientific method is a tool used to generate knowledge in a systematic, orderly, methodical, rational, and critical way, which makes any study reviewable, reliable, and refutable a priori. As they say in the Royal Society, nullius in verba, “on the word of no one.” And it is that someone’s word or reputation should not be enough to make assumptions during a scientific experiment. When evaluating the results of a study, one should not ask who obtained them, but how. Only in this way can science advance – by relying on method, not people. As does the doctor who prescribes amoxicillin to a patient with a gastric ulcer. The doctor makes the decision based on studies that affirm that H. pylori is the cause of most cases, and he does so know that the risk of being wrong is minimal. Intuitively, the physician is applying scientifically established knowledge in patient care. The doctor does not know who Barry Marshall is, but it does not matter either; Their results could be verified more than once because they followed a standardized method, and that is enough.

The world has changed a lot in the last 271 years, and clinical research has changed with it. Today it would be unthinkable to carry out a test under the conditions in which James Lind did. The most notable change that has occurred in this time, without a doubt, is the implementation within the world of clinical research the Good Practice Guide, whose fundamental principles are to protect patients and ensure the rigor of research and, therefore, the veracity of the data and the results. The rights, integrity and confidentiality of patients must be ensured all times during the study, and patients must record their consent before taking part in it. Mr. Lind would find such zeal in protecting the patient strange. If he had the opportunity, he would tell us that the clinical trial is based precisely on not protecting “too much” the subjects, on risking the lives of a few to save that of many. Leaving aside ethics and human rights (concepts that would be anachronistic for him) I would answer him that this is just the way we have, in the 21st century, to ensure that the results of the study are credible. If there is no proof of the patient’s consent, how do we know who gave it? Can doctors base their diagnoses on research in which the most basic and fundamental lied? Again, and as they say in the Royal Society, nullius in verba.

The method matters. It was what allowed Lind to cleanse ships of scurvy for the past three centuries. It is undoubtedly more important than the results of a study, or the researcher who obtains them. And it is that importance that forces a CRA to be by the doctor’s side, day after day, during an investigation. They are not mere CRA bureaucrats trying to put up obstacles to prevent the study from being completed. They, the CRAs, are the ones who, with their know-how, ensure that the method is strictly followed and, ultimately, advance medicine.

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