update
MaD scientists mull apocalypse’s impact on clinical trials
The study – by researchers at the University of Ottawa in Canada – examined what impact an apocalypse coinciding with the end of the Mayan long count calendar on December 21 would have on survival outcomes in clinical trials.
And the results are not positive.
Authors Paul Wheatley-Price and Mark Clemons found that if it occurs, the Mayan Apocalypse – or MaD as they term it – will bring about a statistically significant reduction in trial participant survival rates compared with a control group for which the world does not end.
Curiously, despite factoring in people unlikely to be affected by the apocalypse – such as orbiting astronauts, the grateful dead and ‘men who have read Fifty Shades of Grey’ - the survival rate in the post-MaD group does not drop to zero, which the researchers attribute to slow “zombie repopulation.”
Efficacy
The researchers also looked at the impact the predicted Mesoamerican doomsday may have on drug efficacy trials and it turns out that the extinction of all mankind is likely to be a bit of a problem for contract research organisations (CROs) and pharmaceutical industry sponsors.
“Additional modelling was done to assess the effects of MaD on a sample clinical trial comparing the efficacy of two fictional, although completely plausible, drugs: Toxico and Horribilum. Compared with patients receiving Horribilum, those receiving Toxico had longer median overall survival.
“When the effect of MaD is added to the model, no difference in survival can be seen between the two drugs. Furthermore, any adverse events would not be able to be recorded owing to the mother of all adverse events and any statistical significance between study arms would be lost.”
Wheatley-Price and Clemons are also concerned that the lowering of humanity’s metaphorical final curtain will hinder sponsors’ ability to disseminate the results of clinical research for the benefit of patients and the wider medical community.
Stop all trials
In light of these bleak findings the researchers “recommend that all clinical trials should stop immediately, as MaD will negate all potential trial results” with the caveat that any zombie survivors could play an import role in post market studies.
“Late effects of these drugs could potentially be studied during the zombie repopulation, assuming that the original consent forms would still be considered valid,” they suggest while conceding that “this work may be pragmatically challenging, as we suspect that most members of research teams may themselves be obliterated."
The authors did not respond to Outsourcing-pharma.com's request for comment, although to be fair they may not be able to access emails if they are already in some kind of underground survival bunker.
Doomesday an upside?
UPDATE: Dr Wheatley-Price told Outsourcing-pharma.com that: "If we are proven wrong, and wake up on December 22nd with nothing worse than a headache, then have a very Merry Christmas.
"Upon the somewhat shaky assumption that the apocalypse does not come, clinical trials should return to their primary role of burying investigators in regulatory red tape – and remind us that maybe the end of the world is not such a bad thing after all’
