💊Daily Pill: What is a Preclinical Study?
Test Tubes and Trials
The Daily Pill is a series of very short daily posts where I share the definition of a medical term I think we should all know. Read it every morning and build up your medical vocabulary.
🧬Preclinical Study:
Research that is conducted before a drug, procedure, or therapy is tested in humans. These studies are crucial for evaluating the basic safety and efficacy of a potential new treatment. Preclinical studies are typically conducted in vitro (in a lab setting using cells or tissues) and in vivo (in animals), to gather enough data about the drug’s effects, including its toxicity and pharmacokinetic properties. The outcomes of these studies help determine whether a treatment should move forward to clinical trials involving human participants.
🤔Why you need to know:
Although cell and animal models are a very valuable tool for medical research, at the end of the day animal cells do not fully replicate human physiology. Hence, if you ever see promising data in a preclinical study, take that information with a grain of salt until a properly designed study done in humans comes out.
And even if you see a clinical study done in humans, you can’t hang your hat on that information either because a lot of those studies may have limitations. We typically like to let evidence obtained by different research groups in different organization accumulate first. Once the same conclusions are reached by looking at the same problem from different angles, by different disciplines, and using different methodologies then we can start speaking with confidence about a subject.
🧠Trivia:
About 96% of drugs and therapies that pass animal studies and move on to the next phase, fail clinical trials. This is one of the reasons why the process of drug development is so expensive.