The government needs to obligate pharmaceutical companies to register data concerning their plans, proceedings, and results of clinical trials, to enhance these tests’ transparency and credibility, experts said Monday.

Noting that sharing of clinical trial data is a global trend, these experts exchanged views on how to institutionalize it in Korea, at a symposium jointly organized by the Korea Center for Disease Control (KCDC), National Institute of Health and Rep. Park In-sook of the Bareun Party.

A clinical trials registry is an official platform to register a clinical trial. Although registering clinical trials and their results are legally required in many countries, it is not required by law in Korea.

The clinical trial registry may seem a trivial matter to ordinary people, but it poses complex scientific and ethical questions for parties involved in drug development. The question of who should be able to access clinical trial information has become a crucial one as of late.

Countries around the world have been pushing to improve the transparency of clinical trial results to benefit the medical community and the public. The World Health Organization, along with governments and other international organizations, has called for researchers to make clinical trial information more accessible, and to standardize registries and the overall process.

Korea has been moving in the same direction amid mounting calls for publicizing clinical trial results and strengthening ethical obligations in the process.

Korea’s registry system, called the Clinical Research Information Service (CRIS), is a non-profit online registration scheme run by KCDC and funded by the Ministry of Health and Welfare. It is the 11th member of the Primary Registry in the World Health Organization’s International Clinical Trials Registry Platform (ICTRP). The information on CRIS is open to the public, domestically and internationally, after administrative approval.

Despite these institutions’ encouragement to register clinical trials, no law exists to enforce it. Over the past decade, the government has imposed no legal obligation to publicize data, relying on “good faith of researchers to provide the information” – a policy that has fallen short, according to experts at the debate.

As a result, companies do not want to publicize clinical trials results. These pharmaceuticals conduct clinical trials with private money and therefore believe the data is private intellectual property, according to Jo Dong-chan, a medical correspondent for SBS.

“There are three players in the clinical trial registry process -- the patient, the doctor and the pharmaceutical company. The patient offers their blood, their disease, and the results of taking a particular drug. The pharmaceutical company, in turn, invests money into both researchers and patients to carry out the clinical trial,” Jo said.

Because pharmaceutical companies are investing private resources into conducting clinical trials, they are reluctant to share the results from these studies, especially concerning trials with failed outcomes.

However, experts said the data is not private property but a public one.

“Patients are taking part in tests that do not have a decided outcome,” said Kim Hyun-chul, Professor at Ewha Womans University. “Therefore, they are also contributing, with their lives, to generate results in the clinical study. This gives the public a right to know and a right to access the results of all trials undertaken.”

Jo agreed. “Patients are offering their blood and flesh to provide this type of information to pharmaceutical companies and researchers. The information companies earn should, therefore, be made public. Although it is nice to see discussions regarding legal reforms underway, this problem shouldn't even exist at this point.”

However, some panelists pointed out that mandating clinical trial registry by law may backfire as it may discourage companies from investing in research.

“This is why the law should provide sufficient rewards for pharmaceutical companies to register their clinical trials to make this a reality. It is a difficult task, but it must be done,” Jo said.

To solve the problem of transparency, panel experts called for a legal reform that would make disclosing this information mandatory, as well as to increase accessibility by simplifying technical language and providing analysis of the data that makes it easy for patients to understand.

Panel members pointed to the U.S. as an example. The U.S. has been a first-mover regarding requiring clinical trials to be registered by law. Sponsors in the states have an obligation to register their clinical trials at clinicaltrials.gov, run by the National Library of Medicine (NLM). The registry is the largest worldwide that catalogs 181,612 studies in 50 states and 187 countries as of 2015.

“We have been benchmarking the U.S. over the past decade,” said Jang Yoon-jung from the National Cancer Center. “Now, we need our own set of rules and set of procedures that will incentivize researchers and companies to release this information to the public.”