Amid the protracted Covid-19 pandemic, pharmaceutical and contract research organization (CRO) companies are experiencing difficulties in conducting clinical trials to develop new drugs other than coronavirus-related medicines, industry sources said.
|The Covid-19 outbreak has made it hard for pharmaceuticals and CROs to conduct clinical trials in Korea. (Getty Image)|
For instance, the Ministry of Food and Drug Safety recently issued a statement that researchers planning clinical trials, such as bioequivalence studies, should refrain from gathering 50 or more people during the Level Two social distancing and 10 or more during the Level 2.5 scheme. However, the ministry excluded clinical trials for Covid-19 treatment and vaccines from the new restriction.
In line with the ministry's instruction, some local hospitals, including Yeungnam University Medical Center, Kosin University Gospel Hospital, Keimyung University Dongsan Medical Center, and Kangbuk Samsung Hospital, have closed their clinical trials sites to outsiders.
Local pharmaceuticals and CROs said it is not easy to comply with such toughened rules in clinical trials involving many subjects, and it is also difficult to halt the clinical trials due to their initial schedules.
"To make a patient participate in a clinical trial, medical workers have to explain trial procedures and methods and obtain consent from the patient," a company official said asking to remain anonymous. "In the case of infectious diseases such as Covid-19, contacts between clinical researchers and patients are not easy even at hospitals."
Adding to such problems, the ministry's new rule will likely prolong the trial period, which, in turn, will delay the commercialization process, he added.
"As many clinical sites have banned outsiders, it has become impossible to predict the clinical schedule while the results of the trial must be handed over only after a clinical research associate (CRA) staff monitors the data, an official at a local CRO said. “However, as our CRA staff cannot visit the clinical centers and monitor the result, the process itself cannot move forward.”
Stressing these clinical trials must be conducted according to timelines, she said it is difficult even to establish a plan because few know how long the Covid-19 crisis will last.
Officials at pharmaceutical and CROs said that Korea, too, has to adopt a non-contact clinical trial method to continue trials as an integral part of launching new drugs.
Major regulatory agencies, such as the U.S. Food and Drug Administration, the European Medicines Agency, and the U.K. Drug and Health Management Product Regulatory Authority, are actively recommending virtual trials, or non-face-to-face remote clinical trials, as a method to prevent the spread of Covid-19 in their guidelines.
The companies also maintained that some parts of the data collecting process should be revised to collect such data off-site.
However, other industry officials said that it would be difficult to conduct non-contract clinical trials here due to patient privacy concerns.
The Korean regulations only allow patients information to be accessed inside hospitals, making it essential for CRA staff to visit hospitals and check the data.
In response to such needs, the food and drug safety ministry said it is considering changing part of the regulations.
"We are examining the introduction of a non-face-to-face system in the process of new drug development, clinical trials, and approval review," said Kim Young-ok, director of the ministry’s Drug Safety Division.
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