Reducing the red tape around clinical research is the goal for a group of international specialists who are claiming a step forward with a manifesto against bureaucracy.
Supported by over 1,000 haematology researchers and published in the BMJ, the manifesto is led by Professor Steven LeGouill from the University of Nantes, France and Professor Simon Rule from Plymouth University, UK.
They claim there is the danger of bureaucracy having an adverse effect on the state of global research.
Whilst acknowledging that research is fundamental to the advancement of medical practice and patient outcome, they said ‘the processes behind this have evolved to a place where it has become self-defeating, with an exponential growth in the administration and regulations associated with clinical trials’.
The manifesto is demanding an urgent review of the whole system to ensure patient safety and medical progress and directs the blame for the increase in bureaucracy at all levels.
“The law has not appreciably changed since 2001, but those administering it or working within it are producing increasing bureaucratic demands,” they said.
“The universal explanation for this ever-increasing workload is that it represents “good clinical practice” (GCP) and is there to support the safety of the patient and the integrity of the research.
“It is impossible to disagree with those aims, however this deluge of bureaucracy is in danger of having the opposite effect. We are inundated with multiple amendments many of which have no clinical relevance; receive information on side effects that have been known about for many years, or SUSARs (Suspected Unexpected Serious Adverse Reactions) that are neither serious or unexpected, as well as countless clinically insignificant queries.
“All of these have to be acknowledged through online, password protected systems which are different for different trials and which can mean having to do this multiple times if you are running multiple studies with the same drug.”
Perth haematologist Associate Professor Chan Cheah from Sir Charles Gairdner Hospital and a signatory to the manifesto told the limbic the situation was a global problem with the issues resonating just as much in the Australian context and potentially across all medical specialities.
“The current situation has well and truly lost sight of the true goal of clinical research, and simply increases the costs of research,” he said.
“However change needs to be driven by the regulators such as the FDA, academic investigators and the pharmaceutical industry.”
One unintended side effect of uncontrolled bureaucracy and the increasing cost of clinical trials will be the rapid disappearance of independent academic clinical research or the ability of new investigators to be able to engage in clinical research, continues the manifesto.
“Most of our signatories on the manifesto have been involved with clinical research for years and are fortunate in having research teams around them that help with this ever-increasing workload,” Professors LeGouill and Rule said.
“But for new investigators without any infrastructure to support them, clinical research has become too time consuming and challenging to engage with.
“This review should involve the pharmaceutical companies, independent research organisations, charitable organisations that fund research, clinical teams running studies and most importantly actual patients.”