The CNEP trial: how a good trial was turned rotten
Authors: Kamran Abbasi
Journal: Journal of the Royal Society of Medicine (2010)

One man's pioneering research is another man's research misconduct. But back in October 1989, at the start of a randomized comparison of continuous negative extrathoracic pressure (CNEP) with intra-tracheal positive pressure ventilation in premature neonates, medical researchers were unquestionably shining knights. In the intervening two decades, many medical researchers have been attacked for their evil intentions. Sometimes fairly, when researchers have allowed competing interests, usually financial or career gain, to muddy their work and damage their integrity. Other researchers, however, have become victims of a shambolic and fragmented regulatory system, and a criminally amateurish system for investigating alleged research misconduct.

The researchers involved in the CNEP trial fall into the latter category argue Ed Hey and Iain Chalmers (JRSM 2010;103:133–8). The trial could be considered to have been ahead of its time. The protocol was alpha rated by the MRC. It was ethically approved – twice. It was publicly registered at inception. An information leaflet was provided for parents, and post-trial questionnaires were used to gather parental views. A sequential design was used to monitor accumulating results in the days before data monitoring committees became commonplace. And the trial report was co-authored by doctors, nurses and a statistician.

However, a combustible mix of circumstances turned the CNEP trial into the best example of how to mis-investigate alleged research misconduct. The accusations of distraught and vulnerable parents were understandable, the trial participants were newborn and at risk of early death. But those complaints were seized upon by campaigners seeking to interrogate the child protection work of two of the professionals associated with the trial – Martin Samuels and David Southall. The media amplified the noise, receptive to horror stories about doctors in the era of the Bristol Inquiry into paediatric cardiac surgery, the organ retention scandal at Alder Hey, and the murders of Harold Shipman. Doctors were vilified by the media, portrayed as a rogues’ gallery of butchers and gropers.

The result for the investigators in the CNEP trial and the staff at North Staffordshire Hospital, where the trial was conducted, was a living hell of allegations, media attacks, intrusive scrutiny, and local and national investigations. After 11 years of accusations, investigations, and inquiries – and £6 million in costs – the GMC decided that there was no case for the researchers to answer in respect of the CNEP trial.

This month, the JRSM begins a six-part series examining the outcry that resulted from allegations made about the CNEP trial and its impact on regulation of medical research. Hey and Chalmers set out the background to the controversy and call for the first response to allegations of research misconduct to be that the facts be established by suitably qualified professional investigators. They also argue for a more robust response from professionals to unfair allegations. Why shouldn't professionals use our much maligned libel laws more often to protect their reputations? In subsequent issues, Jonathan Gornall will dissect the role of the media in creating a national scandal out of pioneering medical research. Rod Griffiths will give a blow-by-blow account of the much-criticized government inquiry he headed. He later described his brief as ‘drinking from a poisoned chalice’. Theresa Wright will provide a personal insight into the experience of nursing staff at North Staffordshire Hospital during the height of the controversy. Graeme Catto will explain the GMC's role in investigating the complaints it received while he was president. And Frank Wells will explore some of the history of investigating research misconduct in the UK.

The story is complex yet compelling. But how can we prevent a repeat of this damaging episode? We do now have enhanced systems of research governance, but are they enough? And what evidence suggests that the media will treat the next medical research scandal more responsibly? Our systems of regulation and investigation of researchers and research misconduct have been woefully inadequate, and remain so despite some new initiatives. One answer might be to professionalize research and accredit professional researchers under the auspices of a central regulatory authority, as Dixon-Woods argues in an editorial that accompanies the series (JRSM 2010;103:125–6). A proper, professional system of investigation, one strand of her proposals, should be a minimum requirement.

The tragedy of the CNEP trial controversy is that it could have been prevented, and the damage to people and medical research minimized. Well-intentioned individuals and organizations were asked to pass judgements on matters that they were ill-equipped to investigate. The media was too willing to extract every morsel of sensationalism out of the misery of families. Government was unable and unwilling to accept that its vilification of professionals might have been unfair and wrong, its investigations ill-directed.

Ultimately, though, the CNEP trial harmed medical research because the medical profession remains a quarrelling realm of fiefdoms and glory- hunters, readily manipulated by power brokers and public outcry. Medical research is a sideshow in an unending power struggle inside and outside medicine. Unlike the Bristol Inquiry and cardiothoracic surgery performance data, for example, it is hard to see what meaningful steps have been taken to prevent another damaging research scandal of the magnitude of the CNEP trial.