Various forms of clinical trials have been around since man discovered many things out of curiosity. Some methods were crude, and not everyone agreed with them, but they gave valuable insight into the workings of the human body that no one could deny.
One of the first clinical trials that have similarities to the modern versions is the scurvy trial in 1747 that James Lind conducted. He added many elements that researchers refer to as a controlled trial.
Since the breakthroughs of Lind, the medical field has continued to refine the clinical trial process. In 1943, the Medical Research Council of the United Kingdom carried out the first double-blind trial. The addition of the double-blind was a significant advancement in the process.
As technology advanced even further and people found new ways of conducting their research, the clinical trial process has evolved throughout the years:
1. Design And Statistical Aspects Were Refined
Over the years, studies have become more structured, and research has been done more methodically than in the early years. One of the main design concepts introduced to the process is accurately capturing data that researchers would later use as statistical references.
Putting pen to paper in the form of a journal was the first way many researchers documented their patients’ progress and their methods and procedures. The modern techniques discussed over here are a far cry from the simple rituals of yesteryears.
Many more elements are in the modern trials that researchers didn’t include in their studies before. Due to the improvements and refinements made to the process, more data sets of statistics are available for researchers to compare their findings.
2. Regulatory And Ethics Milieu Changed
There was a realization that these clinical trials performed on patients should be regulated and that researchers should follow a strict code of ethics. Both the regulations and ethics prevented harm to the patients and the researchers.
Before the milieu changed, researchers could perform any study that they deemed necessary, and some had dire consequences. Some research was done by ordinary people or untrained professionals, leaving the patient and their health at their mercy.
3. Adding Placebo Use To The Process
We can define a placebo as a remedy with no significant medicinal or therapeutic value. Most placebo tablets are made of sugar and given to patients as part of the control group in a clinical trial.
Researchers added placebos to the process as a control measure to show the difference between the actual treatment and “fake” medication. The results were not what researchers expected at first, with some of the patients reporting the same effects as the patients who took the actual medication. This reaction from patients gave rise to the term “the placebo effect.”
A placebo is valuable to the progress of a clinical trial. Vital signs and symptoms of patients are monitored along with their mental well-being to obtain the most accurate information.
4. Introduction Of Randomization
Instead of one person, like the person conducting the research, choosing the patients receiving the medication or the placebo, the method of randomization changed the perspective. At first, patients’ names were put into envelopes with no markings or writing on them, and researchers would select a certain number of those patients for the medicinal trial.
Patients whose names remained undrawn would receive the placebo during the study. The randomization of patients ensures no favoritism and that the outcome can’t be affected by the researcher’s bias.
Researchers can’t pick the patients they would have the best results in, and because of randomization, patient results have an equal and fair chance of success or failure.
5. Digitizing Of Responses And Results
When digital technology wasn’t available, researchers would admit patients to a hospital or facility where researchers would apply their therapeutic methods. Nowadays, patients remain in the comfort of their own homes, with minimal interaction from the clinical staff.
The advent of Clinical Research Forms (CRF) changed the way researchers gather information and prepare their results. Having a digital platform that keeps data safe and secure is less troublesome than journals or other physical documentation that could get lost or damaged.
To Accurately Sum Things Up
Clinical trials have been around for centuries, and luckily, through advances in the medical process, technology, and new understanding, they have been refined to what they are today.
If there is one main summary that we can take away from clinical trials, it would be that we should always remain open to learning and progress. Without the founders of the clinical trial process, it would never be as successful today