Analysis report of more than 10,000 drug clinical projects spanning ten years: the clinical development success rate is only 7.9%

Recently, a new report on the success rate of drug clinical development showed that the average success rate of drug development projects from phase 1 clinical trials to the approval of the US FDA for marketing in the past ten years was 7.

Phase 2 clinical has the lowest conversion success rate, and the highest success rate from submission to approval

According to the report, the phase transitions of drug development are defined as the phase of the clinical trial in which the drug is withdrawn: for example, it is moving from phase 1 clinical to phase 2 clinical, or suspended after completing phase 1 clinical.

The analysis found that the success rate from phase 1 to phase 2 is 52.

Picture source: reference [1]

Researchers also analyzed the conversion success rate of drugs in different disease fields at various stages of development.

The conversion success rate of phase 1 clinical trials in different disease fields is between 40.

The average conversion success rate of phase 3 clinical trials in all disease fields is 57.

The conversion success rate (approval rate) of the 14 disease fields in the NDA/BLA stage is between 82.

The average success rate of drug development projects is 7.

Through computational analysis, the researchers found that only 7.

Picture source: reference [1]

Among the 12,728 projects counted by researchers, oncology drug development projects accounted for 33%.

Analysis of the success rate of drug development for rare diseases and high-incidence chronic diseases (tumor indications are excluded in statistics) found that the success rate of drug development for rare diseases is 17.

The conversion success rate of clinical trials of different types of drugs is also quite different.

In addition, the researchers also analyzed the impact of biomarkers on the success rate of drug development.

It took an average of 10.

Picture source: reference [1]

Among the 14 main disease fields analyzed by the researchers, the shortest time for drug development in the allergy field was 9.
2 years, and other disease fields with a development time of less than 10 years include metabolism, infectious diseases, and ophthalmology.
The development time of drugs in the fields of urinary, cardiovascular, and neurological diseases is relatively long, all exceeding 11 years, of which the urinary field has reached 12.
2 years.

The average time for drug development in the oncology field is 10.
3 years.
From the perspective of different development stages, the longest transition time for phase 1 clinical is in the tumor and urology field (both 2.
7 years), the longest transition time for phase 2 clinical transition is in the urology field (5.
0 years), and the duration of the phase 3 clinical project The longest is the cardiovascular field (4.
2 years).
It is worth mentioning that the shortest time from submission of NDA/BLA to approval of drugs in the oncology field is 0.
8 months.
This is also the only field in the 14 disease fields where the regulatory approval time is less than one year.