In 2013, Christina Reith, fellow of The Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians, lead authored a paper that addressed in no uncertain terms what effect red tape was having on clinical trials in Europe. Her conclusions were damning – that for academics engaged in carrying out randomised control trials, the most pressing of issues were those of regulation and funding challenges, which created a number of significant delays and unexpected cost increases when carrying out clinical trials.
The BMJ (British Medical Journal) cites the above in a January article authored by a number of prominent Belgian researchers, who echo Reith’s 2013 concerns. The researchers, led by Kristina Vermeersch of KU Leuven, note that: “The problem that has emerged in academic clinical research is not a failure to adhere to regulations, but an expenditure of vast amounts of research time and money on the collection of irrelevant data and exhaustive documentation.” So when one of the world’s oldest and most respected medical journals makes such a claim, with no sign of progress on the issue over the last decade, how might the industry respond?
The issue of overly complex bureaucracy is nothing new to professional industries, least of all those in the medical field. Clinical research, by nature, seeks a delicate balance between cost, safety and efficiency. Historically, however, change comes at a snail’s pace. Regulations are often based around outdated societal needs and create a plethora of logistical problems.
The National Medical Products Administration’s (NMPA) formation in 2018 identified – correctly, if some of Europe’s top researchers are to be believed – the removal of bureaucratic hold-ups in the biopharmaceutical industry as one of their primary aims upon formation. In a world with an ever-growing population, they recognised that an inconsistent CTA timeline was a serious inhibitor to growth. In China clinical research has absolutely staggering potential, with 58% of Chinese residents living in urban areas, thus creating some of the easiest access to large patient volumes anywhere on the planet. With China clinical trial quality already having attracted the attention of serious multinationals, and looking set to increase, the NMPA appears to be moving swiftly along the right track.
Looking ahead into the 2020s, this adaptation will grant significant advantages to healthcare companies that utilise the Chinese CRO market over their European counterparts. While the Clinical Trials Directive 2001/20/EC in Europe is under reform to better homogenise procedures, it is itself hampered by slow-moving bureaucracy. By the time the new Clinical Trials Regulation is fully in effect, a healthcare company opting to use a top Chinese CRO will have already been operating clinical trials for potential treatments for a significant period of time, unburdened by overly extensive regulations.
Between the period of 2007 to 2019, registration of trials on the US Clinical Trials portal quintupled in Chinese study centres. Amongst improvements, pioneering attitudes and foreign investment, the world’s second-largest pharmaceutical market will undoubtedly see further maturation in the near future.