Are FDA's requirements for Chinese pharmaceutical companies reasonable?

At 11:00 .

The applicability of China's clinical research data to the American population, the "Spring Festival Gala" of the Chinese pharmaceutical industry in the era of drug problems

A very basic and important question is:

"Does it matter whether the clinical trial population is the American public? Does the FDA have any requirements or minimum requirements for the proportion of the American public in the trial population? If so, how much?"

There are at least two ways to answer this questio.

Study the relevant data of previous FDA-approved new drugs, and use the data to speak

In this article, Drug Times solemnly recommends the 7-year-old Drug Trials Snapshots, the "Drug Trials Snapshots" column launched by the FDA to Chinese pharmaceutical companies and peers, which contains a large amount of clinical trial data, and these data Exactly what Chinese companies need, valuable in answering questions and answering our question.

Drug Trials Snapshots

FDA Drug Trials Snapshots

FDA Drug Trials Snapshots

In January 2015, the FDA's CDER launched "Drug Trials Snapshots," a section aimed at enhancing FDA transparency, sharing information on the diversity of participants in clinical trial.

Drug Trials Snapshots Clinical Trial Participant Diversity

(Image source: FDA official website)

The 2020 Drug Trials Snapshot Annual Report summarizes the 2020 Drug Trials Snapshot program, highlighting 53 of the latest FDA-approved drugs and biologic.

2020 Drug Trials Snapshot Annual Report

(Image source: FDA official website)

CDER hopes this information will help facilitate conversations about the reasonable representation of different subgroups in clinical trials, and welcomes industry feedback on the Drug Trials Snapshot Program and ideas on how FDA can further enhance the information provided in each snapsho.

In 2020, CDER approved 53 new drugs, including as new molecular entities (NMEs) under a New Drug Application (NDA) and as new therapeutic biologics under a Biologics License Application (BLA.

(Image source: FDA official website)

As can be seen from the table above, 56% of the 32,000 participants were female, 75% were white, 8% were black or African American, 6% were Asian, 11% were Hispanic, and 30% were 65 years old and abov.

Subjects from US clinical trial centers accounted for 54% of all subjects

Table 2 below provides demographic data for all 53 CDER-approved new drug.

(Image source: FDA official website)

If we focus on the indicator of the proportion of subjects from US clinical trial centers in all subjects, the data for 5 drugs is 0, and the data for the other 7 drugs is greater than 0, but less than or equal to 10.

If we focus on the indicator of the proportion of subjects from US clinical trial centers in all subjects, the data for 5 drugs is 0, and the data for the other 7 drugs is greater than 0, but less than or equal to 10.

This means that these 12 drugs accounted for 26% of the 53 approved new drug.

This means that these 12 drugs accounted for 26% of the 53 approved new drug.

Analysis of the three therapeutic areas

The main therapeutic areas for new drug approvals in 2020 are: Oncology, Neurology and Infectious Disease.

Oncology, Neurology and Infectious Diseases

Oncology

Oncology

A total of 4,922 patients participated in trials in 2020, and 18 new drugs were eventually approve.

41% are from the US

Demographic data for each approval is provided in Table 3.

(Image source: FDA official website)

Unsurprisingly, new anti-tumor drugs received the most attention, ranking first in the number of approval.

New anti-tumor drugs

If we focus on the proportion of subjects from US clinical trial centers in all subjects, there are 4 drugs whose data is less than or equal to 10.

If we focus on the proportion of subjects from US clinical trial centers in all subjects, there are 4 drugs whose data is less than or equal to 10.

This means that these 4 drugs account for as high as 22% of the 18 new anti-tumor drugs approve.

This means that these 4 drugs account for as high as 22% of the 18 new anti-tumor drugs approve.

Neurology

In 2020, a total of 5,598 patients participated in trials and 6 new drugs were approve.
Overall, 74% of all subjects were female, 87% were white, 3% were Asian, 8% were black or African American, 9% were Hispanic, and 5% were 65 and older, 46% are from the United State.

46% are from the US

Demographic data for each approval are provided in Table 4.

(Image source: FDA official website)

If we focus on the indicator of the proportion of subjects from US clinical trial centers in all subjects, there are 3 drugs whose data is less than or equal to 10.

If we focus on the indicator of the proportion of subjects from US clinical trial centers in all subjects, there are 3 drugs whose data is less than or equal to 10.

This means that these 3 drugs account for up to 50% of the 6 new neurology drugs approve.

This means that these 3 drugs account for up to 50% of the 6 new neurology drugs approve.

infectious disease

infectious disease

In 2020, a total of 4,659 patients participated in trials and 6 new drugs were approve.
Overall, 36% of subjects were female, 32% were white, 6% were Asian, 9% were Black or African American, 16% were Hispanic, 16% were 65 and older, 30% were from the United State.

30% from the US

Demographic data for each approval are provided in Table 5.

(Image source: FDA official website)

If we focus on the indicator of the proportion of subjects from US clinical trial centers in all subjects, the data for 4 drugs is 0.

If we focus on the indicator of the proportion of subjects from US clinical trial centers in all subjects, the data for 4 drugs is 0.

This means that these four "Zero Egg" drugs account for as high as 66% of the six approved new infectious disease drug.

This means that these four "Zero Egg" drugs account for as high as 66% of the six approved new infectious disease drug.