Difference between Preclinical Trials and Clinical Trials on Drug Products

• Preclinical Testing  in New Drug Development
• Clinical Testing  in New Drug Development
• Stages of Clinical Testing on Humans
• The Importance of Collaboration and Transparency in Drug Development

Preclinical and clinical testing are crucial stages in the development of new drugs to ensure that the drug being developed is safe, effective, and meets quality standards before being used by the public. Additionally, data from preclinical and clinical tests provide the scientific evidence required to obtain regulatory approval for market authorization in a given country. 

These testing processes are carried out in stages, with preclinical testing conducted first, followed by clinical trials. This step-by-step approach allows developers to eliminate failed candidates early, thereby reducing financial and time-related losses.

Preclinical Testing in New Drug Development

Preclinical testing is the stage of research conducted before a drug is tested on humans. The goal of this phase is to ensure that the drug candidate has sufficient safety and efficacy potential before entering clinical trials. During preclinical testing, the drug is tested on animal models that have disease characteristics similar to human conditions. 

Additionally, this testing can also be conducted using artificial systems (in vitro) that simulate human disease conditions, such as using human cells or tissues in culture. Preclinical testing aims to determine a safe starting dose for clinical trials in humans and identify potential toxicity. Furthermore, this phase also involves the development of initial drug formulations to ensure effective drug delivery according to its therapeutic needs.

Clinical Testing  in New Drug Development

Clinical testing is the stage of testing conducted on humans to assess the efficacy and safety of a drug. Before starting clinical trials, drug developers must first perform extensive evaluations of preclinical tests to ensure that the drug is safe to test on humans. Subsequently, developers must design and propose the clinical trial plan, as well as prepare the preclinical data and clinical plans to be submitted to regulatory authorities for further review.

Stages of Clinical Testing on Humans

Clinical testing on humans is carried out in several phased stages: phase 1, phase 2, phase 3, and phase 4. Clinical testing in phase 1 is performed on 20-80 healthy volunteers to assess the drug's safety, pharmacokinetics, pharmacodynamics, side effects, and formulation. Placebo may sometimes be used in phase 1, depending on the study design. 

In phase 2, testing involves approximately 100-500 patients suffering from a specific disease related to the drug's intended indication, to measure the drug's effectiveness against the target disease. In this phase, there are groups of volunteers given a placebo or existing treatments for the disease, to compare the new drug with current treatments and determine whether the new drug has a better or comparable profile. Phase 2 also evaluates the side effects and risks of the drug, as well as assessing the appropriate dose for the next phase. 

Phase 3 involves a larger group of patients, typically 1,000-5,000, to gather further data on the drug’s efficacy, dosage, and toxicity in a wider population. Based on the phase 3 results, adjustments are made to the drug label to ensure proper and safe use of the drug. Phase 4 clinical trials take place after the drug has been approved by regulatory authorities and is marketed. 

These trials monitor the drug's safety, effectiveness, and performance in the general population. In phase 4, drug developers are required to report any side effects reported by patients, healthcare professionals, or hospitals to ensure that the drug remains safe after being distributed to the public.

The Importance of Collaboration and Transparency in Drug Development

The stages of preclinical and clinical testing are critical steps in the development of new drugs, ensuring both the efficacy and safety of a drug. Therefore, it is essential for drug developers to strengthen collaboration between researchers, pharmaceutical companies, and regulatory bodies to ensure that each phase of preclinical and clinical testing is conducted with high levels of transparency and integrity.

Ready to take your drug candidate to the next level? Ensure comprehensive preclinical and clinical trials are conducted in accordance with applicable scientific and regulatory standards. And conduct preclinical and clinical trials of your drug product in a trusted laboratory.

Author: Devira
Editor: Sabilla Reza

References:

Singh, N., Vayer, P., Tanwar, S., Poyet, J.-L., Tsaioun, K., & Villoutreix, B. O. (2023). Drug discovery and development: introduction to the general public and patient groups. Frontiers in Drug Discovery, 3. https://doi.org/10.3389/fddsv.2023.1201419.