With more than 300,000 subjects and hundreds of millions of yuan for clinical trials, is there still a chance to reduce the cost?

According to the experience of those who have come, clinical development of cost-saving technology involves two aspects: the strategy and tactics at the macro level should be correct; at the micro level, it is necessary to decide whether to use CRO and how to use it

In June 2022, a report from Junshi Biosciences in response to the Shanghai Stock Exchange's review inquiry letter lifted the veil of the high clinical development costs in the pharmaceutical industry

In this way, the nearly 4 billion yuan that Junshi raised was actually not spent

Clinical trials are the most important and most expensive part in the process of launching new drugs.

Fees are like water in a sponge, and a squeeze always saves

01 Subtraction of CRO

The main payment objects of a clinical trial generally include: research centers, clinical CROs, and SMOs

Among all the costs of clinical trials, clinical CRO services are the most expensive, "accounting for about 40% to 50% of the total cost", a person in charge of clinical operations at Biotceh revealed

CROs play an important role in the research and development of new drugs, which is the result of the division of labor in the market.

In recent years, with the increasing number of innovative pharmaceutical companies and the increase in the number of new drug clinical trials, the shortcomings of these companies' lack of bargaining and management capabilities have gradually emerged in the face of large CROs

"Watching people eat dishes" is a major complaint made by different small innovative pharmaceutical companies to large CRO companies in the interview.

However, the essential contradiction between pharmaceutical companies and clinical CROs is not here

Time has become the tug-of-war between the interests of both parties, and has also become a key indicator of clinical cost control.

"For the development cost of a single drug, the cost of using CRO outsourcing services is theoretically about 20% to 30% higher than the company's own clinical research management team

But not all start-up companies have the ability to build their own clinical teams.

For start-ups, a more suitable way to save costs is to manage CRO effectively

"First of all, the company must have a person who understands clinical management; secondly, it must choose a suitable CRO; thirdly, negotiate the content of the contract with the CRO to avoid the situation of adding services after the start of the trial

Some interviewees also mentioned that in addition to CRO fees, the fees paid by sponsors to research centers also accounted for a considerable proportion of the entire clinical process, "some may account for about 30%"
.
However, the reduction of the cost of this link may need to be realized after the homogeneous competition projects are cleared, and the supply and demand of clinical resources tend to be balanced
.

Saving money by managing CRO is an external control, and saving costs through a reasonable pipeline layout is an internal control
.
"The key to controlling R&D costs is the scientific pipeline layout, the overall path of product development and clinical development strategies,
" said the person in charge of the aforementioned company's clinical operations
.

The high degree of pipeline homogeneity is one of the main reasons for driving up the cost of clinical trials
.
The same targets and similar pipelines will inevitably lead to a run on various resources such as subjects, clinical bases, and PI, and the result is a jump in costs
.

Bio-Tech terminated the clinical trials of three new drugs under development in March 2021, which caused heated discussions in the industry.
Now it seems that Bio-Tech's timely stop loss has its merits
.
However, if an enterprise wants not to waste money in follow-up research and development, the most important thing is to be rational and cautious when setting up a project, and avoid blindly following the trend
.

02 Integrate global clinical resources

Due to the different approval standards and subject resource reserves of regulatory agencies in different countries, the time consumed for clinical trials in different countries is also different.
Sponsors can save costs by integrating global clinical resources
.

The earlier the clinical start, the faster the progress, the greater the time savings, and the greater the opportunity for cost savings
.

At present, some domestic Biotech companies have begun to choose to do Phase I or Phase II clinical trials in Europe and the United States, and then return to China to do Phase II or Phase III clinical trials through bridging trials, and apply for listing in China
.
"For clinical trials applied for at the same time, European and American countries can start 3 to 4 months earlier than in China
.
" A corporate CMO revealed
.

If the ultimate goal of a company's product is to go global, then globalization should be considered at the beginning of clinical trial design
.
If the initial clinical trial does not adopt the international standard, there may be problems in connecting with international standards, the overall trial period will be longer, and the cost will be higher
.

Doing clinical Phase I or Phase II abroad, returning to China for Phase II or Phase III through bridging trials, and then applying for listing in China is a way to promote products to market faster and save costs by integrating global clinical resources
.

Under the circumstance that there is no racial difference in the researched drugs, the "staggered peak" selection of regions can effectively reduce the cost of trials
.
Some rare disease drug development can try this way
.

The most notable feature of rare diseases is that the patient population is small.
Compared with other diseases, it is more difficult to enroll patients in clinical trials of rare disease drugs, and the cost of clinical trials is also higher
.

However, compared with European and American countries, China has a large population base, and the results of some rare diseases in China are "not rare", and there are many patients
.
For drugs under development for such diseases, companies can choose to do Phase I abroad and Phase II or Phase III in China to solve the problem of insufficient subjects for key clinical trials
.

By dispatching global clinical resources, companies have the opportunity to recruit more subjects, speed up clinical trials, and effectively reduce clinical costs
.

Overall, there are many benefits for Chinese companies choosing to go abroad for clinical trials
.
"First, open up the international market and take the road of globalization; second, the quality of clinical trials is higher, and the implementation is in line with international standards; third, there is no significant difference in the cost of clinical trials at home and abroad; fourth, it can be clinically implemented faster; Fifth, it can reduce unnecessary experiments and shorten the research and development cycle
.
" The aforementioned CMO concluded
.

Clinical trials are the most critical factor in determining whether a drug can be marketed, and it is also the most expensive part of drug research and development.
If global clinical resources can be integrated and effectively managed under the trend of globalization, the success rate and efficiency will also increase.
The greater the improvement, the higher the survival rate of the enterprise
.