groups » Trial Management » April Issue of the Month: Research Misconduct and Withholding unfavourable results - what can be done?
In the past six months there has been a lot of news in the worldwide trials community about research misconduct. This mainly has related to the issue of research not being published when results are unfavourable, as has been highlighted extensively in the media with the publication of the book "Bad Pharma" by Ben Goldacre, and various articles such as:
"Industry sponsorship leads to bias in reported findings of clinical trials" (http://www.sciencecodex.com/industry_sponsorship_leads_to_bias_in_reported_findings_of_clinical_trials-103704)
"Have we all been deceived?" http://globalhealthbioethics.tghn.org/blog/post/525/2012/12/have-we-all-been-deceived/
There has been a move to have mandatory publishing and reporting for ALL clinical trials, including sharing information about methods. There is an ongoing campaign for this, initiated by the Centre for Evidence Based Medicine, the Bad Science group, the BMJ, Sense about Science and others - you can read about it at www.alltrials.net. So far, this has gained much support, including with some pharmacetuical companies including GSK. However, this does not cover other types of clinical research and we would be interested to hear readers' opinions on the topic.
This month, we are also fortunate to have one of the authors of new PLoS article "Research Misconduct in Low- and Middle-Income Countries" available for comment. This article (you can find it in the 'Resources library) highlights a range of different examples of research misconduct. We are keen to hear the Global Health Trials community's thoughts on research misconduct and how it can be avoided - and that includes misconduct of all types, including withholding unfavourable results. Will the 'AllTrials' campaign solve the problem? Let us know what you think.
An interesting article here on the same issue, from Sir Iain Chalmers and published by the MRC.
I would like to say that These discussions touch on both research misconduct and fraud. Once researchers develop clinical trial protocols and take them through different tiers of approval as per requirement, it is expected that trials are conducted in such a manner that research ethics, good clinical practice, good clinical laboratory practice, and applicable regulatory requirements as per country. The various stakeholders have to be respected and integrity upheld in the period of trial conduct and post trial period. We have seen lately PhDs, masters theses being nullified and awards revoked. This means that human research cannot be exempted from scrutiny and if there is any bias from any quota, these should not be entertained at whatever cost. It is important to report findings whether negative or positive to inform the research fratenity on lessons learnt but more importantly, participants are protected from unscrupulous pharma and sponsors.
As the article accurately points out, misconduct touches a broad range of problems (fabrication, falsification and plagiarism, ethical breaches and other questionable research practices).
These problems originate from different and often concomitant causes, including but not limited to the poor ethical and regulatory oversight, the pressure to publish, the pressure to bring a new product on the market as soon as possible, the lack of training and awareness in research ethics and research integrity etc. Thus, this is a complex problem, which must be addressed through regulation and oversight mechanisms but also, as Steve also said in his above post, by a kind of "cultural change", by creating an environment where research intergrity is promoted and incentized at all levels,
Misconduct in practicing clinical trial may be very broad. Publishing protocols with the methods used is not the only solution, but the big solution i would think is for all investigators have and observe self motivation of adhering and practice what the research ethics demands according to the local bodies.Treating the participants with high respect and confidentiality even in absence of supervision and monitoring by different bodies.Investigators should not prioritize sponsors and Funders interests most.
This article, published this week, is relevant to this discussion:
Use of Trial Register Information during the Peer Review Process
Sylvain Mathieu, An-Wen Chan, and Philippe Ravaud. PlosOne:
There's been an interesting move from the British Medical Association, which may be of interest to readers - the BMA has voted to make non-publication of trial results to now be considered research misconduct, and that doctors involved in withholding results should be referred to the General Medical Council. For more information see: http://www.alltrials.net/2013/bma-votes-that-non-publication-of-trials-results-is-research-misconduct/ - do you think other organisations will follow in thier footsteps?