As initially reported by Radio Free Asia, many articles claimed the majority of trials in the country were fabricated. Following such reports the CDFA has released further information about “the issues on authenticity.”
An official from the Department of Drug and Cosmetics Registration of CFDA was interviewed in a press release issued on Friday last week.
The official confirmed that registration applicants were required to complete “self-examination on the authenticity, integrity and compliance of clinical trial data.”
1,429 registration applications were involved in the examination, although it is unclear how or why these specific applications were chosen.
“By the end of June, 2016, 1,193 voluntary withdrawals happened after self-examination of the companies, accounting for 83% of the total number of registration applications for self-examination,” according to the CFDA statement.
During its review process of the remaining applications, which concluded last month, the CFDA verified 117, 30 of which were rejected “due to defects with authenticity,” accounting for “about 2% of the total number of registration applications for self-examination and verification,” the CFDA said.
Outsourcing-Pharma.com previously reported that 81% of the select applications had been withdrawn, as per the report published in Chinese on September 20, 2016 – this number specified both applications voluntarily withdrawn and the 2% rejected by the agency.
The CFDA added that 27 applications and 11 clinical trial institutions as well as the CROs “suspected of providing fraudulent data” have been investigated.
However, the CFDA official emphasized that there are many reasons for companies withdrawing their applications.
“Some were for nonconformance to the Good Clinical Practices, which could affect the scientificalness and accuracy of the clinical trial results; some were for data incompleteness, which could not be traced back, and were insufficient to demonstrate the safety and effectiveness for the drug in application; some were for untruthful data, part of which cannot be excluded of the possibility of deliberate data fraud,” the CFDA said in its statement.
“Therefore, the reports that “80% of China’s clinical trial data are fraudulent” by some media are not fact based,” it concluded, referring to several media reports of the issue.
EMA responds to globalization challenges
When asked to comment on the report, the European Medicines Agency (EMA) told us it has been tracking the geographic origins of patients included in pivotal trials submitted in marketing authorizations to the centralized procedure.
“China represents less than 1% of patients in pivotal trials included in marketing authorizations applications submitted to the Agency,” the EMA said.
“It is likely that the reason for this low representation is the intrinsic differences between the Chinese and European population and potential differences in medical practice, disease definition and study population that could influence the applicability of clinical trials in China to an EU setting.”
The EMA has coordinated 12 good clinical practice (GCP) inspections in China since 2000, in connection with the assessment of human medicinal product marketing-authorization applications by the Committee for Medicinal Products for Human Use (CHMP).
According to the agency, critical findings were only reported in relation to one inspection and the issues identified were taken into account during the evaluation procedure.
“In order to address the challenges arising from the increasing globalization of clinical research the Agency developed a strategy on the acceptance of clinical trials conducted in third countries for evaluation in marketing authorization applications,” the EMA said.
The CFDA and the US Food and Drug Administration (FDA) did not respond to a request for comment.