Australia’s clinical trials register is at risk of being exploited by clinics advertising “pretend” trials to solicit business for expensive unproven stem cell therapies.
Academics including Sydney-based pathologist and haematologist Professor John Rasko and US bioethicist Dr Leigh Turner have warned of a worldwide trend in which clinics engaging in direct-to-market advertising of unproven stem cell treatments register “pay-to-participate” or “patient-funded” clinical trials for the apparent purpose of attracting patients and engendering a sense of scientific legitimacy.
In a recent article in Regenerative Medicine, Dr Turner described how such listings on the US-based ClinicalTrials.gov register had become “an effective way for businesses selling stem cell interventions to solicit prospective clients”.
This can occur because registers do not have a vetting process, Professor Rasko told the limbic.
“There’s a lot of these (providers) that are creating almost “pretend” clinical trials,” he said. “They are not even really clinical trials but people misunderstand what clinical.trials.gov is. It’s just a registration system.”
The NHMRC-funded Australian New Zealand Clinical Trials Registry (ANZCR) – which lists approximately 70% of home-grown trials – also does not vet trial applications.
“We have identified some stem cell trials of the type Drs Rasko and Turner describe, particularly in the past few years,” said ANZCR manager Associate Professor Lisa Askie.
“We recognise that the use of the term ‘registered’ may confer some unintended legitimacy to trials of dubious quality, and of course any such instance of this is of concern to us,” she told the limbic.
The purpose of the register – run out of the University of Sydney – is to improve the transparency of clinical trials, which once listed on the register can’t be removed.
In Australia, it is mandatory for trials to have prospective registration to be eligible for approval by a human research ethics committee.