The nationwide experiment will initially include around 100,000 volunteers.
The BMJ inquiry finds that researchers presented only select results from animal experiments when applying for funding and approval for human trials.
January 11, 2018|
FLICKR, NIAIDOxford University scientists developing the MVA85A vaccine, intended as a booster to the established Bacille Calmette-Guerin (BCG) tuberculosis (TB) vaccine, misrepresented preclinical results to obtain funding and approval for a 2009 clinical trial in South Africa that failed to show any benefit, according to an investigation published in The BMJ yesterday (January 10).
In applications provided for funding and ethical and regulatory approval of the trial, as well as in the information given to parents enrolling their children as participants, the researchers included claims that the MVA85A booster had proven safe and more protective than BCG alone in multiple animal models. But according to the investigation, the team was “privately playing down or dismissing unsupportive experiments as ‘failed’ or irrelevant,” writes Deborah Cohen, associate editor at The BMJ. Indeed, a 2015 review by researchers at Stellenbosch University in South Africa found that animal study results for MVA85A did not support its use as a BCG booster.
Ewan McKendrick, registrar of Oxford University, tells The Independent that three separate investigations by Oxford University cleared the researchers of “any wrong-doing,” and adds that the team had “observed the highest scientific and ethical standards.” But if the researchers really did lack transparency in reporting the preclinical results for the MVA85A vaccine, it isn’t an isolated incident, Jonathan Kimmelman of the Biomedical Ethics Unit at McGill University in Canada notes in a press release. “Unfortunately, there are other cases where new treatments were put into human testing on animal evidence that was foreseeably flawed, incomplete, or even negative.”
Speaking with MedPage Today, Kimmelman says that not only do regulators sometimes fail to recognize the fallibility of promising animal findings, but that some may even actively overlook equivocal or negative results. “Research programs are like supertankers,” he says. “Once they are up and running they have their own momentum, and it is really, really difficult to stop them.”
Another part of the problem may be the lack of oversight of preclinical research, for which there is no central registry like there is for clinical trials, Malcolm Macleod of the University of Edinburgh writes in an editorial in The BMJ accompanying the investigation. “We need to develop better and more systematic ways to establish when a drug is ready for clinical trials in humans—and importantly, when it is not.”