One of the biggest beneficiaries of scientific methodology is evidence-based modern medicine. Each step in the ‘bench to bedside‘ process is a testimony of the scientific rigour in medicine research. While the low probability of success (PoS) at each stage is a challenge in the race to fight against diseases, it increases the confidence level in the validity of the final product.
The drug development process is divided into two parts: basic research and clinical research. Translational research is the bridge that connects the two parts. The ‘T Spectrum’ consists of 5 stages,
T0 includes preclinical and animal studies.
T1 is the phase 1 clinical trial for safety and proof of concept
T2 is the phase 2/3 clinical trial for efficacy and safety
T3 includes the phase 4 clinical trial towards clinical outcome and
T4 leads to approval for usage by communities.
Probability of success
According to a publication by Seyhan, who quotes NIH, 80 to 90% of research projects fail before the clinical stage. The following are typical rates of success in clinical drug development stages:
Phase 1 to Phase 2: 52%
Phase 2 to Phase 3: 28.9%
Phase 3 to Phase 4: 57.8%
Phase 4 to approval: 90.6%
The data used to arrive at the above statistics was collected from 12,728 clinical and regulatory phase transitions of 9,704 development programs across 1,779 companies in the Biomedtracker database between 2011 and 2020.
The overall chance of success from lab to shop thus becomes:
0.1×0.52×0.289×0.578×0.906 = 0.008 or < 1%!
References
Seyhan, A. A.; Translational Medicine Communications, 2019, 4-18
Mohsa, R.C.; Greig, N. H.; Alzheimer’s & Dementia: Translational Research & Clinical Interventions 3, 2017, 651-657
Cummings, J.L.; Morstorf, T.; Zhong, K.; Alzheimer’s Research & Therapy, 2014, 6-37
Paul, S.M; Mytelka, D.S.; Dunwiddie, C. T.; Persinger, C. C.; Munos, B.H.; Lindborg, S.R.; Schacht, A. L, Nature Reviews – Drug Discovery, 2010, VOlume 9.
What is Translational Research?: UAMS
