*
The clinical trials industry is a highly regulated field because the stakes are very high and touch the rights, health and security of trial participants, and the millions of users afterwards. The full compliance with the established local and international laws and regulations is of paramount importance. There are strict requirements for the quality of the generated data, which has to fully meet the highest analysis standards of the regulatory agencies, Data must be complete, well documented and traceable.
Unfortunately this is not always the case in every country. Even if the local regulations for the clinical trials conduct and management follow the international Good Clinical Practices (GCP) Guidelines set by the International Council for Harmonization (ICH), they are often not applied in similar lines to the Western practises.
A recent review of the China Food and Drug Administration (CFDA) concluded that more than 80% of 1622 applications for mass productions of newly developed drugs have hidden or deleted records of potential adverse effects, and data that did not meet projections may have been tampered. Many of the new drugs were a combination of existing drugs, with clinical trials outcomes written beforehand and the data tweaked to fit in with the desired outcomes.
The local Contract Research Organizations (CRO) were quoted in the CFDA report as being “accomplices in data fabrication due to the cut-throat competition and economic motivation”. By the end of June 2016, according to the CFDA statement 1193 voluntary withdrawals were made after self-examination of the companies, eg. 83% of the total number of the registered applications. During the process of the CFDA review, from the remaining 117 applications, 30 were rejected “due to defects with authenticity”.
In its statement CFDA said that there are many reasons for companies withdrawing their applications. Some were for non-conformance to the Good Clinical Practices, which could affect the scientific value 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, for part of which the possibility of deliberate data fraud cannot be excluded”
When asked to comment on the report, the European Medicines Agency (EMA) said that 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 the marketing authorizations applications submitted to the European Medicines Agency” the EMA speaker said.
The reason for this low representation is the intrinsic differences between the Chinese and European population and the potential differences in medical practice, disease definitions and study population that could influence the applicability of clinical trials in China to an EU setting.
Other emerging markets also faced allegations of corruption and malpractices, and face charges. The lack of adherence to the Good Clinical Practices and to the high Quality Assurance requirements is the reason why the vast majority of the clinical trials are still conducted predominantly in the developed countries where the standards of quality are well set and followed.