[Reporter’s View] COVID-19 trials still in smooth progress?

COVID-19 developers have been announcing that they will discontinue their clinical trials one after another.

 

In just 10 days, Celltrion, Chong Kun Dang, and CrystalGenomics publicly announced that they will discontinue their COVID-19 clinical trials.

 

When counting from January, the number increases to 5 with Genexine and HK Inno.N.

 

The news of the discontinuation was received with the response that it was as expected.

 

However, there is no reason for the companies to be criticized for discontinuing their clinical trials.

 

Strictly speaking, only 10% of the drugs succeed in receiving final approval for their treatment or vaccine after initiating clinical trials.

 

Rather, the companies can be regarded as being ‘honest,’ as they announced the discontinuation officially to their investors.

 

If no official announcement is made on the discontinuation, there is no way for outsiders to know the progress made within a company.

 

Even if a pharmaceutical company internally decides to abandon development, they can pretend that the trial is still ‘well in progress’ externally by not officially getting rid of their trials.

 

There have been many cases where development has been silently scrapped this way.

 

Pharmaceutical companies would sneakily announce their trial discontinuation after investors’ interest wanes.

 

The same goes for COVID-19 trials.

 

When pharmaceutical companies first rushed in to start clinical trials for COVID-19 treatments two years ago, there was skepticism on whether those were a ruse to ‘raise stock price.’ With this skepticism unresolved, many trials are still ‘well in progress.’ From the investor’s perspective, they can never know how many companies have been ‘serious’ in conducting their clinical trials.

 

The Ministry of Food and Drug Safety discloses the progress of clinical trials as ▲ Completed ▲Recruiting ▲Completed Recruitment or ▲Terminated, but it is impossible to confirm how many patients were recruited after trial approval.

 

In other words, there is no way to know how actively the company is recruiting patients for its trials.

 

The clinical trial registry ClinicalTrials.gov operated by the US National Institutes of Health (NIH) offers a more detailed view on the progress of its clinical trials.

 

The progress is categorized as ▲Not yet recruiting ▲Recruiting ▲Active, not recruiting)▲Suspended ▲Terminated ▲Completed ▲Withdrawn ▲Unknown.

 

In particular, the ‘Active, not recruiting’ category deserves attention.

 

This means the study has started, but its potential subjects have not been recruited or registered yet.

 

It indirectly shows the company's degree of engagement in conducting its clinical trials.

 

Starting next year, the Ministry of Food and Drug Safety plans to publicly disclose the results of the factual survey that was conducted to secure the transparency and reliability of clinical trials.

 

However, the disclosed contents will not contain the progress made by each clinical trial.

 

Therefore, referring to the US cases to secure transparency and trust in domestic clinical trials may also be a viable option.