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.
Dr Turner has suggested the US-based register ClinicalTrials.gov needs to vet applications in order to weed out suspect trials.
But Prof Askie said the ANZCTR is unable to do this on current funding – which allows less than 60 minutes for each application to be processed – and without the detailed trial information provided in confidence to ethics committees.
However, steps have been taken to prevent the register from listing dubious trials since the risk was identified in 2015.
“Within our remit and current resourcing, when we identify such trials we ask for evidence of (Australian) Ethics Committee approval and may decide not to proceed with registration on ANZCTR if this is not forthcoming.”
Labelling conventions on the register have also changed, with trials that do not have ethics approval receiving only a “provisional registration”.
Professor Askie said at the time, the idea of only displaying trials with ethics approval was considered, but deemed to interfere with transparency aims.
“If Prof Rasko and Dr Leigh can give us some realistic suggestions regarding how the ANZCTR staff can efficiently, effectively and accurately recognise every ‘marketing-in-disguise’ trial, without access to all the information an Ethics Committee has, and within the current ‘less than one hour per trial’ of staff time available, then we would be very happy to hear these.”
“In our experience, the vast majority of trials submitted to ANZCTR are legitimate.
“Rather than resourcing the ANZCTR to thoroughly ‘vet’ every trial submitted for registration in order to identify the very few ‘bad apples’, a better strategy might be establish a Federal Office of Clinical Trials and/or a Clinical Trials Ombudsman to which suspect trials can be referred and investigated more thoroughly by staff that have the required investigative skill set and the authority to impose sanctions,” she suggested.