The results of a clinical trial involving 27 children in Texas have gotten lost in a sandalwood plantation in northern Australia. How on earth did they get there?
A team of TranspariMED volunteers recently tried to track down the results of trial NCT02024581, which set out to examine the safety, tolerability and efficacy of a sandalwood oil cream in children suffering from molluscum contagiosum, a largely benign skin disease.
Under U.S. law, the results of that trial should have been made public on the ClinicalTrials.gov registry more than four years ago, but have not been posted there. A systematic search of the medical literature also drew a blank.
So where are the results?
To find out, we had to contact the sponsor (i.e. the company) that ran the trial. ClinicalTrials.gov lists ViroXis Corporation as the sponsor, but ViroXis no longer exists. In 2015, ViroXis was acquired by a different company called TFS, which was subsequently renamed Quintis.
According to its website, Quintis:
“Quintis owns and manages the world’s largest Indian sandalwood plantation spanning over 12,000 hectares across northern Australia. We are a specialist plantation manager with over 20 years’ experience in nurturing and cultivating sustainable and legal Indian sandalwood…”
As well as growing trees, Quintis also produces Indian sandalwood logs, chips and powder, and “steam-distilled Indian and Australian sandalwood oil,” which is presumably why they decided to acquire ViroXis eight years ago.
We contacted Quintis about the trial’s results. Their lawyer responded that:
“Clinical Trial NCT02024581 was terminated due to internal administrative reasons. The study only had 19 active participants before the study was terminated… With so few active participants ViroXis Corporation considered that the results would not be valid nor attractive to potential publishers (i.e., journals). The Quintis Group value safety and ensure compliance with all laws… As the study was not completed and was terminated, ViroXis Corporation is not required to publish results.”
Actually, the last bit is incorrect. Under U.S. law, applicable trials must make their results public even if they are terminated early – but it’s difficult to blame a foreign forestry company for not being fully conversant with FDAAA Section 801 and 42 CFR Part 11.
Blame the FDA
That law has been on the books since 2007, but even today the FDA does not routinely send out warning letters when results have become overdue, so many sponsors neglect - or simply forget - to meet their obligations.
Such obligations can then be transferred to other actors through mergers and acquisitions. A second ViroXis trial, NCT03158974, which involved adults with genital warts, followed the same route and has also ended up being on Quintis’ books.
Thanks to FDA’s inaction, an Australian forestry company now has to try to unearth the data of two long-abandoned clinical trials, perform a statistical analysis, and upload the results onto the world’s premier source of medical research data.
Is this really a sane way to communicate medical evidence in 2023?
TranspariMED would like to thank Quintis for responding to our enquiry, and volunteers Samruddhi Yerunkar, Okan Basegmez, Ronak Borana, Belén Chavarría, Mayra Velarde and Nicholas J. DeVito for contributing to the project that detected this trial.
Please contact us if you want to join future TranspariMED projects as a volunteer.