A letter from ACTA's Chair, Prof John Zalcberg was published in the bmj today:
Re: Bureaucracy is strangling clinical research
Picture a small 2m2 room in the ward, crammed with seven virtually identical ECG machines.
Each provides a typical ECG trace. In each case, the recording allows the measurement of electrical abnormalities of the heart with appropriate sensitivity and specificity. The P-R interval, Q-T interval, amongst a range of measures, are all provided. Each was procured separately for their respective clinical study taking place in the hospital and can only be used for that specific study. There are seven ECG machines in this room because each of the respective pharmaceutical companies claims the Food and Drug Administration (FDA) has insisted on dedicated ECG equipment for their specific study and that any existing hospital equipment (whether state-of-the-art or otherwise) is not suitable.
None of these ECG machines provides any additional information to that provided by the current suite of ECG machines used throughout the hospital for the routine care of patients.
Every time a new piece of equipment is brought into the hospital, trial approval is delayed by approximately a month as the hospital’s clinical governance processes engage with biomedical engineering, infection control, purchasing departments, etc.
I do not know whether the FDA has insisted on a separate ECG machine for each study, or whether this is the interpretation of the pharmaceutical company or the Contract Research Organization. What I do know is that it exemplifies the bizarre bureaucracy that my colleagues in Europe have recently highlighted and one that I have no doubt would be echoed by the 10,000 clinicians that work within the clinical trials networks that are members of the Australian Clinical Trial Alliance.
But whatever the explanation, it highlights the desperate need for Regulators around the world to provide some sensible guidance to those endeavouring to bring new drugs to market. Many patients around the world have been the beneficiary of the explosion of new drugs, the development of which has depended on carefully conducted clinical trials. However, as my European colleagues have so eloquently highlighted, research bureaucracy is threatening to strangle this golden goose. Surely it’s time for some urgent action!
Competing interests: No competing interests
John R Zalcberg
Chair, Australian Clinical Trials Alliance
Alfred Health and Monash University
553 St Kilda Road Melbourne 3004, Australia