Bench-to-Bedside: How Basic and Clinical Scientists can work to improve drug safety and efficacy

Here is your daily, non-COVID, non-US election, non-massive world ending disaster post for the day. It’s nice to get something like this these days.

If you look at the common pathway of drug development, you will notice something like this: Pre-clinical -> Phase I -> Phase II -> Phase II -> Phase IV. Without going into too many details the phases are described as so: Pre-clinical is experimental development with testing in laboratory animals. Phase I is a small batch of human volunteers (typically healthy or within a small target population). Phase II is a larger batch to improve therapeutic safety and determine dosing ranges. Phase III is larger target populations to further determine safety and efficacy. Phase IV involves post-market surveillance after the drug is approved from success in Phase III.

Interestingly, this “classical” paradigm of drug development leaves out the ever important need to bring a drug to Phase 0 trials. Phase 0 occurs between the pre-clinical phase and the initiation of Phase I clinical trials. Phase 0 clinical trials can occur at a single institution and typically recruit 10-15 volunteers to receive micro-doses of the new drug in order to confirm the drug’s safety, bioavailability, and half-life. Interestingly enough, this Phase 0 portion of the drug development timeline is typically skipped for direct entrance into Phase I trials. Why is this? I believe the basic science field can aid in this transition by being actively involved in Phase 0 clinical trials prior to sending a drug off to Phase I.

Bringing basic scientists into the clinic might sound like a dangerous mix between egos, but in-fact might help to improve the synergy between the clinical and experimental worlds. Merck, Novartis, and Pfizer are three companies that adapted the the Phase 0 trial into their regular practice since its first designation in 2006. It is here that we can see basic scientists benefiting the bench-to-bedside effort and enter the clinic and ensure the proper translation of a drug from the experimental to clinical.


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