From Animal Testing To Human Clinical Trials
As cruel as some animal rights activists might think it is, every drug we now have owes its existence to animal testing. If you follow our blog or you’re otherwise interested in clinical research, you know that the very first phase of a clinical trial or phase 0 is testing the new drug on animals. And not any animals, mind you, as testing is usually done in rodents and not for example in chimps, though they are more closely related to humans. But why?
Today on the FindMeCure blog we’ll talk about our favorite topic – clinical trials, more precisely how clinical trials are built and conducted. Many of you are probably wondering why a drug should be tested on animals at all if humans can have a different reaction anyway. If you have similar questions or you’re concerned about what happens to phase I volunteers after the drug has been tested in mice, read on.
Firstly, what about animal suffering? We want to reassure you in advance that animal testing is not done blindly. Way before a new drug is tested on a living being, it’s tested in vitro, meaning in a vial, and scientists are able to predict to a great degree the anticipated reactions. You see, not only are there regulations to ensure the humane treatment of animals but animal testing is also an expense – no company would pay to test a drug that doesn’t show significant potential. And at this initial pre-trial phase, showing potential means the drug is safe enough in the first place. Lab rats are definitely not randomly injected with substances to see if they survive and if that’s how you imagine animal testing then you’ve fallen victim to wild misconceptions.
Okay, animal testing is predominantly safe for the animals and even they are no ‘guinea pigs’ in the process. Why rodents though? Well, one of the reasons has to do with resources – it’s simply cheaper and easier. Rodents are easier to breed and test on. Of course, another reason for the choice of rodents is the question of humane testing – testing on our primate cousins is subject to more regulations and logistical issues. But to put it plainly, rodents are similar enough to us where it counts. Researchers can also optimize rodents genome in such a way that it’s easier to observe what the new drug can do to the body and take into account all the ways it can interact with the organism it’s injected into.
This similarity between the way mice react to new drugs and therapies and the way humans react when testing is done on human volunteers is the reason why the medical world is so enthusiastic about the potential new way to fight superbugs. Let us elaborate on this one. The 25-year-old Ph.D. student at the University of Melbourne, Shu Lam, may have found a groundbreaking way to fight antibiotic-resistant superbugs. She developed a star-shaped polymer (a large molecule) that works by ripping apart the cell walls of superbugs. Although the polymer has only been tested in the lab and on one superbug in live mice, the medical research world is hopeful because so far the polymers, called SNAPPs (structurally nanoengineered antimicrobial peptide polymers), repeatedly kill the targeted bacteria without creating resistance.
Promising results of animal testing still doesn’t mean the drug will be effective in humans or even safe, to begin with. Even phase I volunteers, however, are no guinea pigs – the trial protocol ensures the drug is administered safely and adverse effects can be anticipated and treated accordingly. There is MABEL among many other precautions. MABEL stands for minimum anticipated biological effect level and it’s a measure used to determine the minimal dose safe for injecting into a human organism for first-in-human clinical trials. Not only that but technology has advanced enough so that scientists now can develop a computer model to predict some of the effects the drug can have on people.
If this is the case, however, and we can create computer models of molecules to see how they interact with each other, why is animal testing even needed? Technology is increasingly helpful in predicting outcomes and making the testing process safer and easier but it can never substitute testing a drug on a living being. There are just some reactions that are linked to the complexity of the body and all of the processes taking place and interacting with each other and the substance that’s introduced.
The debate of whether animal models can accurately predict the relevance a new discovery will have on human health is ongoing. Animal testing has always played a crucial role in medical progress as unpleasant as the notion might be to people who oppose it. It’s true that the only reliable source of insight about the human body are humans but animal models are an important first step in order to ensure the maximum safety of the human volunteers. It’s plain to see how important animal models are when we take a look at the 2018 Nobel Prize winners James Allison and Tasuku whose work in mice has furthered progress in the field of cancer immunotherapy.
The way medical scientists build the link between animal testing and first-in-humans clinical trials has evolved over the last few decades to ensure the volunteers’ safety and largely eliminate the margin of human error. Guidelines and safety protocols are constantly improving in order to assess and predict outcomes. Not only does it make trials safe for human participants but it also gives only the best new drugs a chance to prove themselves, thus sparing resources and time. After all, therapies that show a lot of potential can benefit patients sooner if the trial is built and conducted in a safe and productive way.
Keep all of this in mind if you’re considering joining a clinical trial. Trials are not shots in the dark but rather a well-constructed process of evaluating promising therapies. You can join a trial either to be among the first to receive a novel treatment or to help further medical process in a field you’re particularly interested in. Either way, while searching for the right trial of FindMeCure, you should be aware that medical research is an exact science and it doesn’t leave much to chance.