The Lancet: New changes in clinical trials of lung cancer drugs in China after 15 years

Article source: Med

Author: Zuo Yi

As the "number one killer" of malignant tumors, the incidence and mortality of lung cancer have always been high.

A few days ago, Professor Shi Yuankai from Cancer Hospital of the Chinese Academy of Medical Sciences and Professor Han Xiaohong from Peking Union Medical College Hospital, as co-corresponding authors, published an article in "The Lancet Regional Health-Western Pacific", collecting and analyzing The registration research on the three websites of drug clinical trial registration and information disclosure platform, China Clinical Trials Registration Center and ClinicalTrials.

Researchers and domestic manufacturers are the main force in clinical trials

Among the 1,595 clinical trials of anti-lung cancer drugs registered from January 1, 2005 to December 31, 2020, investigators initiated 630 clinical trials (39.

In terms of trends, the number of clinical trials initiated by researchers between 2017 and 2020 has continued to grow, with an average annual growth rate of 47.

Figure 1: The number of anti-lung cancer drug clinical trials initiated in China each year from 2005 to 2020

Guangdong, Beijing, Shanghai

Main clinical trial initiation base

As can be seen from the figure below, 278 trials were initiated by researchers from Guangdong, followed by Beijing (n = 273) and Shanghai (n = 257)

Figure 2: Distribution of main clinical trial units of anti-lung cancer clinical trials in provinces, cities, and autonomous regions from 2005 to 2020

The author pointed out that at this stage, more clinical trial resources are allocated to leading hospitals.

The number has increased sharply since 2013, with the largest growth rate in Phase I research

From 2005 to 2013, the number of clinical trials of anti-lung cancer drugs was very small, but it slowly increased over time.

Figure 3: All clinical trials of anti-lung cancer drugs (including IND and IIT) in various research phases in China from 2005 to 2020

Among the four different stages (I-IV), the growth from 2013 to 2020 is the largest in period I, followed by periods IV, III, and II, with average annual growth rates of 38.

Targeting, immunity, the undoubted number one hot spot

From January 1, 2005 to December 31, 2020, among the 965 registered clinical trials initiated by manufacturers, targeted drugs accounted for the largest proportion (588 cases, 60.

Figure 4: The number of annual clinical trials of new anti-lung cancer drugs by drug category in China from 2005 to 2020

Since 2013, the number of trials involving targeted drugs has continued to increase, with an average increase of 34.

Figure 5: The distribution of targets in clinical trials of targeted anti-lung cancer drugs in China from 2005 to 2020

The number one hot spot for targeted drugs is EGFR (epidermal growth factor receptor)

Figure 6: Mechanism distribution of clinical trials of anti-lung cancer immunotherapy in China from 2005 to 2020

In terms of immunotherapy, PD-1/PD-L1/CTLA-4 inhibitors represent the most popular strategy

Enlightenment and reflection

In recent years, the pattern of sponsors for clinical trials of anti-lung cancer drugs in China has changed

Although significant progress has been made in the past 15 years, there are still shortcomings that need to be improved

The author stated that the study also has certain limitations

In general, the study summarized the changing trends of clinical trials of anti-lung cancer drugs in China from 2005 to 2020 for the first time, and provided useful information and direction for researchers, pharmaceutical companies and other stakeholders

references:

ZHONG Q, TAO Y, CHEN H, et al.
The changinglandscape of anti-lung cancer drug clinical trials in China from 2005to 2020[J].
The Lancet Regional Health-Western Pacific, 2021, 11: 100151.