Releasing a new drug or medical treatment for practical use is a detailed and complicated process – as it should be. Companies with new revolutionary medicines often get slowed down by the processes put in place to keep people safe, so having a thorough understanding of those processes can make a huge difference in your speed-to-market.
This blog will provide descriptions of both preclinical and clinical trials and point out some of the differences in the technologies required to pass through each clinical stage of the process.
We’ll start with the basics of a clinical vs. preclinical trial.
A preclinical trial aims to test factors such as efficacy, toxicity, pharmacokinetics, and safety information. For example, a toxicology report can help you determine a safe dosage for your drug during clinical trials, as well as weed out ingredients and chemical combinations that are toxic altogether. Companies may run into clinical trial obstacles during this phase of development, however, this gives scientists their first look at potential safety and efficacy issues during development.
Analyzing a drug’s behaviors in a test tube or cell culture environment is known as in vitro testing. In vitro tests can tell us how your product interacts with human cells to understand better how they react with a living human. Doing the preclinical trial outside of a living organism is a safe bet when your toxicology report was inconclusive.
In vivo translates to “within the living.” This type of preclinical testing uses a whole, living organism to test drugs and treatment reactions. If In vivo is being used in a preclinical study, animal testing is the likely method.
Preclinical trials can also be conducted via computer models to demonstrate drug-target interactions. This process, known as in-silico profiling, uses the internet to pull from thousands of studies and pieces of tested information to determine how unfamiliar chemical compounds may react in a drug. In-silico profiling has had highly positive feedback in malaria studies concerning drug resistance and can provide a wealth of information regarding preclinical trials.
Once you have positive results in your preclinical trials, you can get started testing your drug on humans.
Phase 0 studies are not required as part of development but may test a drug’s pharmacokinetics or movement and absorption through the body. Using a small sample of 10-15 subjects, the clinicians administer sub-therapeutic doses to their test subjects to make a note of targeted areas of the body. Additionally, these studies do not report on safety or efficacy because most dosing is too low to cause a therapeutic effect.
Early Phase (I-II)
Phases 1 and 2 assess a drug’s safety by administering higher and higher dosages to pinpoint the right one. Here, clinicians will ask a slightly larger group of patients to try their drug until the side effects begin to appear. An experienced clinical operations team will also test to determine different interactions when their medication combines with another one on the market. Phase 1 studies can be done in healthy volunteers or in subjects with the disease under study.
Late Phase (III-IV)
Once you establish safety in the Early Phase, Phase 3 compares the drug in question with its standard-of-care drug to determine if it’s more or less effective in a larger population. Finally, FDA testing and approval occur and Phase 4 studies are initiated to identify rare side effects and long-term effects.
The Importance of Great Data Analysis
To get FDA approval, you need to have accurate and precise clinical data. Throughout your entire study design, be aware of regulatory issues that might affect your data collection strategies. Working with preclinical scientists will help you stay organized and comprehensively manage every aspect of your preclinical and clinical trials.
You’ll want to make sure your data science methods are equally flawless. Clinical data science can help you navigate and hypothesize from thousands of data points. Effectively organizing patient data and information can be a massive help throughout every step of your clinical trial.
A life sciences consultant can integrate Software Quality Assurance into your data operations to maintain a high level of efficacy in your study results.
Remember that the technology and data science you use for preclinical and clinical trials will affect your FDA approval, as well as your ability to launch your product in the market.
If you’re looking for a little extra guidance or a top-down life sciences consultant for your pharmaceutical trials, Treximo can help you along the way. Our team of experts is adept at handling these cases from the outset of your preclinical studies to Phase IV clinical trials’ final data wrap-up.
Contact us today to hear more about how we can get your product on the market fast.