Preclinical animal research is necessary to develop new drugs for humans. While this research has flaws and limitations, it is essential, but this relationship is extremely complex. Animal studies are indispensable in drug development, but significant challenges seen with these studies must be considered when undertaking this research. What should people know about preclinical drug research when determining whether the benefits outweigh the risks? When should this research be conducted, and why?
What Flaws and Limitations Come with Animal Studies?
Many people feel animal studies are necessary today, as humans need drugs to overcome the many illnesses that plague them. They don’t take into account the flaws and limitations of these studies. Animals have physiological differences that could lead to different outcomes for them compared to human outcomes. A drug may appear very promising when tested on animals, but it may not affect human subjects.
Researchers at Hera BioLabs use systematic approaches to improve methodological robustness. However, they still face inherent limitations. For example, species-specific biological differences can lead to significantly different outcomes. Drugs used successfully in animal studies rarely translate to clinical use. Only 8% of these drugs are clinically used within two decades, which shows the drawbacks of these studies on animals.
Furthermore, animal studies are often not reproducible. Biological variations play a role in this lack of reproducibility, and standardization and trial designs make this problem more challenging. Researchers refer to this as the reproducibility crisis, which leads to Individuals questioning how accurate these studies are in predicting human efficacy and safety.
Drug Discovery
Countless drugs are discovered each year. However, very rarely do these drugs produce the desired effects. Preclinical models aren’t helpful in many cases because they don’t accurately predict humans’ response to the drug. A drug that may provide outstanding results in animals may not affect humans, and a drug that does not affect animals may be very effective in humans. Researchers cannot predict this from the studies they conduct. Furthermore, they can’t always detect toxic effects when studying animals, as humans may respond differently. Most new drugs are discovered after an unpredictable occurrence rather than through animal testing.
Side Effects
Another problem researchers face is significant side effects often don’t appear for an extended period. Humans widely use the drugs before these side effects are detected, as they weren’t present in animal studies. Countless class action lawsuits have been filed for precisely this reason. Drug manufacturers may promote products believing they are safe for human use, only to learn later that they are dangerous or deadly. The manufacturer must alert the public when they discover this information or face legal action.
How Can These Challenges Be Overcome?
Researchers must find ways to overcome these challenges in animal studies. They may need to improve the study design, methodology, or complementary human relevance systems to do so. Improved predictive models and testing methods are necessary to understand the intricacies of human biology and diseases. Microphysiological systems and artificial intelligence are two ways animal studies might be improved to provide better and more accurate results.
Researchers must recognize the value and limitations of animal studies if they wish to advance drug development. New approaches are constantly being developed, and some work incredibly well. Researchers can agree on one thing. Animal experiments and drug safety testing are necessary, and we must embrace the opportunities to better the health of all humans.