"New Drug Development: Estimating entry from human clinical trials", Adams & Brantner 2003:
"This paper analyses a detailed data set on drugs in human clinical trials around the world between 1989 and 2002. The data provides information on the probabilities with which drugs successfully complete the different phases of the trials and the durations of successful completions. The paper shows that success rates and durations can vary substantially across observable characteristics of the drugs, including primary indication, originating company, route of administration and chemistry. It suggests that analysis of this type of data can help us to answer questions such as: Do AIDS drugs get to market faster? Do Biotech drugs have higher probabilities of getting to market? This paper provides some general statistics for analyzing these questions...Our basic summary is that approximately 1 in 8 drugs that entered Phase I are launched on the US market.
Note that according to the FDA, only 1 in 1,000 drugs pass the preclinical stage and are proposed for testing in humans (FDA, 2002). However, almost half the R&D expenditures occur in the preclinical stage of development (Levy, 1999)
Pharmaprojects contains information on 27,987 new branded drug entities that have reached the late stage development from 1980 to 2002. For the purposes of this study, we limited the sample size to the 3,328 drugs that have entered either Phase I, or Phase II, or Phase III of the human clinical trials somewhere in the world for the first time since 1989.
On average, it takes just under 8 years for a drug to go from Phase I of human clinical trials to market launch in the US. The same figures for Phase II and Phase III drugs are 6.1 and 3.7 years respectively. More specifically, an average drug spends 1.7 years in Phase I, 2.4 years in Phase II, and 3.7 years in Phase III before launch.
Graph 1 presents a graph showing the estimated duration for the drugs in the data set by their primary indication. While it takes just 5.5 years on average for HIV/AIDS drugs to get from Phase I to the market, it takes drugs for Parkinson’s disease almost twice that long to go through the same process. Drugs for arthritis also spend more than 9 years, and asthma drugs spend more than 8 years in clinical trials on average. HIV/AIDS, anti-hypertension, and leukemia cancer drugs are some drugs that spend less than 7 years in clinical development. Again, this result is suggestive, but more sophisticated analysis is necessary to determine whether more important drugs get to market faster, and why."
"This paper analyses a detailed data set on drugs in human clinical trials around the world between 1989 and 2002. The data provides information on the probabilities with which drugs successfully complete the different phases of the trials and the durations of successful completions. The paper shows that success rates and durations can vary substantially across observable characteristics of the drugs, including primary indication, originating company, route of administration and chemistry. It suggests that analysis of this type of data can help us to answer questions such as: Do AIDS drugs get to market faster? Do Biotech drugs have higher probabilities of getting to market? This paper provides some general statistics for analyzing these questions...Our basic summary is that approximately 1 in 8 drugs that entered Phase I are launched on the US market.
Note that according to the FDA, only 1 in 1,000 drugs pass the preclinical stage and are proposed for testing in humans (FDA, 2002). However, almost half the R&D expenditures occur in the preclinical stage of development (Levy, 1999)
Pharmaprojects contains information on 27,987 new branded drug entities that have reached the late stage development from 1980 to 2002. For the purposes of this study, we limited the sample size to the 3,328 drugs that have entered either Phase I, or Phase II, or Phase III of the human clinical trials somewhere in the world for the first time since 1989.
On average, it takes just under 8 years for a drug to go from Phase I of human clinical trials to market launch in the US. The same figures for Phase II and Phase III drugs are 6.1 and 3.7 years respectively. More specifically, an average drug spends 1.7 years in Phase I, 2.4 years in Phase II, and 3.7 years in Phase III before launch.
Graph 1 presents a graph showing the estimated duration for the drugs in the data set by their primary indication. While it takes just 5.5 years on average for HIV/AIDS drugs to get from Phase I to the market, it takes drugs for Parkinson’s disease almost twice that long to go through the same process. Drugs for arthritis also spend more than 9 years, and asthma drugs spend more than 8 years in clinical trials on average. HIV/AIDS, anti-hypertension, and leukemia cancer drugs are some drugs that spend less than 7 years in clinical development. Again, this result is suggestive, but more sophisticated analysis is necessary to determine whether more important drugs get to market faster, and why."
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