The Korea branch of QuintilesIMS, the world's leading clinical services organization (CRO), received a warning Wednesday for not reporting serious adverse effects during clinical trials to regulatory authorities.
Side effects are common in clinical practice. If the clinical drug is of greater benefit and effectiveness than the side effect, the drug may be licensed or an additional indication for treatment. However, fixed-term reports of the occurrence of significant adverse events are considered an important issue in human clinical trials.
According to the rules on the Safety of Medicines (Article 30, Paragraph 1, Item 13), the clinical sponsor should report to the prescribing director and the investigator within 15 days from the recognition of all severe and unexpected adverse drug reactions. In the case of death or life-threatening during the clinical period, it should be reported within seven days from the time when the relevant fact is recognized.
The clinics get warning if they violate the safety measures a second time, facing the
suspension of 15 days. As the same situation repeats, the intensity of administrative disciplines rises, which can lead to a severe disruption to the clinical trial.
The clinic, which received the warning, was testing Imbruvica (ingredient: Ibrutinib), Janssen's anti-cancer drug, which was approved by QuintilesIMS Korea on Oct. 7, 2015.
An official at the Ministry of Food and Drug Safety said, "We sent a warning to QuintilesIMS Korea on a delayed report of a significant and unexpected adverse reaction."
In the first phase of treatment for patients with metastatic pancreatic adenocarcinoma of the global clinical stage 2 and 3, Ibrutinib and Gemcitabine has compared placebo with Gemcitabine and Nab-paclitaxel combination therapy.
QuintilesIMS Korea conducted the largest number of clinical trials among CROs here in the first half of this year.
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