In January 2017, the US passed new regulations to ensure that all clinical trials would have their results reported within one year of primary completion – with hefty fines of up to US$10,000 a day for those who failed to comply with the new rules. Despite this, a recent study published by The Lancet found that almost six in 10 trials conducted in the US did not report their findings in a timely fashion.
The US remains for now the largest pharmaceutical market worldwide, and with the Chinese pharmaceutical market growing at a staggering rate, becoming mired in bureaucratic non-compliance is far from the idyllic scenario for the US$1.3 trillion industry.
Even more concerning is the lack of consequences that the FDA has imposed on companies failing to adhere to their rules. Dr Ben Goldacre of Oxford University, who led the research published in The Lancet, stated that: “Our study has identified over 2,400 trials breaching the rules, but to our knowledge the FDA has never levied a single fine or other enforcement action, despite all the levers available to them.” This contrasts starkly with the attitude shown by the NMPA (National Medical Product Administration), which shortly after its formation in 2018, aided in a mammoth fine totalling US$1.32 billion against Changchun Changsheng Life Sciences Limited. At the time, Li Jiang, speaking on behalf of the NMPA, declared that: “Serious punishment for the case will serve as a warning for drug safety and shows the authorities’ resolution to crack down on drug violations and protect people’s health.” China clinical trial quality has seen massive leaps in the last decade, and Li’s statement demonstrated that failures to adhere to new standards would not be overlooked.
In addition to – or perhaps, because of – this lack of punishment, there appears to be little progress by many of these US-based companies to reach full compliance. The proportion of compliant trials as compared to the number of overall trials carried out has remained similar since July 2018. These consistent failures not only breach participant trust, but waste a huge proportion of finite research resources and undermine the integrity of clinical medicine.
Even further, when breaking down those trials that did not comply, researchers found that trials which used a US Government sponsor were in fact the least likely to submit results in a timely fashion, with a mere 31% of trials submitted on time, compared to 50% with industry sponsors and 34% with non-industry sponsors. Co-author Nicholas DeVito, also of Oxford University, noted that: “The fact that the US Government cannot comply with its own laws is particularly concerning.”
The US government currently sits at historically low levels of trust globally, and the data above is just a minor facet of that. While in the world’s second largest pharmaceutical market, China clinical research has shown consistent progress, fundamental infrastructure improvements and a willingness to actively pursue quality, the US shows a lack of enthusiasm not only in following new rules but also in enforcing them.