Clinical trials have been a vital part of modern medicine for a long time, with the official first trial dating as far back as 1747. There are some other instances before then, but Dr. Lind’s experiment stands out the most. On the 20th of May of that fateful year, British physician James Lind began conducting the first official clinical trial. He was aboard a ship, and twelve men of the ship’s crew were plagued with scurvy. Dr. Lind decided to treat the twelve of them with different scurvy medications. The aim was to find the most efficient form of treatment. He divided the twelve into pairs and treated each pair with a different medication. After six days, the pair he treated with oranges and limes were up on their feet, reporting for duty! Dr. Lind reported this in his journal and later published it in his book “Treatise of Scurvy” in 1753. This work influenced the British government to make oranges and limes a compulsory part of the seafarers' diet.
In recent times, James Lind’s work has been commemorated in many ways, including the adoption of May 20 as International Clinical Trials Day.
This story is one prime example of how clinical trials have made life better for humanity. There are a lot of other stories and noteworthy examples, such as French surgeon Ambroise Paré’s accidental discovery in 1537 and Dr. Watson’s study of smallpox in 1767. These trials have, in no small way, improved our lives and health-care even though they occurred hundreds of years ago. In the rest of the article, we will discuss what clinical trials really are and explore how they have changed health care remarkably.
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What’s To Know About Clinical Trials?
We are talking about how clinical trials have drastically improved our lives over the years. But before we dive in, let’s explain what clinical trials really are. Definitions, types, methods, implications, and everything in between.
First off, let’s start with a proper definition of the term “clinical trials.” Clinical trials are a series of tests or examinations done on people to find better or new ways to treat a disease or condition. Clinical trials always involve humans and are meant to make improvements to already existing treatments. They can also be used to initiate new alternatives. There are two main types of clinical trials: observational and interventional. Observational trials follow only an observational approach. The researchers observe and record the outcomes of people already taking certain medications. Interventional, on the other hand, relates to dividing participants into groups and then comparing the different “interventions” or methods of treatment so as to determine certain criteria. There are other, more specific types of clinical trials, but they generally fall under these two.
Next, we’ll discuss the phases of clinical trials. You might have heard of drugs or treatments that are in phase I or phase III trials. There are four stages to a clinical trial, each of which is assigned a number from I to IV. Each increasing number shows an advancement in the adoption of the drug. The four phases are as follows:
- Phase I—Safety and Dosage: Is the drug safe, if yes, what dose is safe enough? This stage uses a minimal number of volunteers
- Phase II—Efficacy and Side Effects: This stage checks how effective a drug is. It checks for side effects and other related issues. The drug is tested on a larger group of people who are already treating the condition.
- Phase III—Alternative Comparison: In this stage, the treatment is compared with existing treatments so they can find out its overall efficiency. This stage uses an even larger group than both phases I and II.
- Phase IV—Long-term Safety: At this point, the treatment might have already been approved but is still under observation so researchers can make sure it’s as safe as possible. In this stage, the data from people using the drug is monitored to see the treatment’s progress.
All clinical trials can only occur if the Nuremberg Code is followed; otherwise, they would be termed illegal and punishable by law.
Clinical Trials In The Last 40 Years
In the last four decades, the amount of progress seen in modern medicine can be defined as unrivaled. This speedy progress has been in many ways amplified by the ethical use of clinical trials in studying drugs. In the last forty years, there have been many noteworthy advancements in modern medicine that have been catalyzed by clinical trials. We’d explore a few of them and discuss their long-term impact on our healthcare system. Let’s dive in.
A great place to start might be the relatively recent discovery of the gene-editing technique—CRISPR in 2013. This ingenious medical innovation has been predicted to be a potential method for treating numerous diseases, including cancer and HIV/AIDS. Another noteworthy study that shows the importance of clinical trials is the case of the recent Ebola virus outbreak in 2013. Clinical trials in Guinea for a 2016 vaccine, Ervebo, were needed to authorize the drug for treatment. At the end of the day, it helped fight the outbreak in West Africa and potentially saved thousands of lives.
There are many more instances of how clinical trials have affected our lives positively. In the next section, we will be covering a much more in-depth study that proves this point even further.
14.2 Million Life-years Gained!
One especially dominant area is the treatment of cancer. In recent years, the search for a cure for cancer has been at the forefront of medical research and experimentation. Even though that goal has not been achieved, progress has been remarkable considering the complexity and broadness of the disease. A recent study by the National Cancer Institute spanning the last four decades has further strengthened these claims. The National Clinical Trials Network (NCTN), a member of the NCI, showed in a statistical analysis that clinical trials in the last four decades had provided 14.2 million life years to cancer patients!
Even more interesting is the fact that this feat comes at a relatively low cost of about $330 in federal investment per life year. The study comes from data collated from about 2,200 treatment sites in the US, resulting in approximately 108,334 patients who underwent phase III clinical trials from 1980 to date. The NCI picked 162 different studies in the last four decades that produced positive results and, at the end of the day, reached the approximated 14.2 million life-years figure they published in the Journal of Clinical Oncology.
This study might sound a bit too positive, but the data shows just how important clinical research is to the advancement of modern medicine. When we break down the study, we see that a few steps were taken to eliminate any bias. For example, the 162 trials chosen came from high-caliber studies that had been cited about 170,000 times in total. Additionally, 91% of them were also published in high-impact journals, all in a bid to show the study’s potency.
We’ve seen how important clinical trials are to the advancement of healthcare. However, the public is not suitably educated on this importance. This is shown in people's bias toward undergoing clinical therapy and their unfounded fear of participating.
Most clinical trials have little or no risk attached, with the majority of them predicting only slight discomfort, with serious, life-threatening complications arising on rare occasions, according to the National Institute of Health. Additionally, research groups are obligated to inform you of all possible risks and compensate you for your participation. Governing bodies also monitor these trials, which are lawfully conducted under the Nuremberg Code and other country-specific rules.
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