jueves, 7 de marzo de 2013
La importancia de publicar todos los ensayos clínicos
La investigación de nuevos tratamientos se basa en estudios científicos. Las industrias farmacéuticas los llevan a cabo invirtiendo enormes cifras. El problema aparece cuando únicamente se publican los resultados favorables al medicamento que se quiere comercializar, no publicándose y destruyéndose los resultados no concluyentes o desfavorables.
Esta omisión de información es gravísima porque podría salvar vidas al mejorar las indicaciones y el uso de los tratamientos.
Por eso pido públicamente que apoyen la campaña: All trials registered firmando con su email aquí (no tardarán ni 15 segundos).
Sense about science nos aporta la opinión de gente muy sesuda con argumentos de más peso:
An editorial in the BMJ today spells out that academics as well as companies need to report the results of their trials. Editor in Chief Fiona Godlee calls on both industry and academia to clean up their act and invites BMJ readers to add their voice to the petition at www.alltrials.net: “The evidence that much research goes unreported is overwhelming, putting patients at risk and wasting healthcare resources.”
Tracey Brown, Director, Sense About Science: “Everybody agrees that all clinical trials should be registered, and that we should at the very least have access to the basic results, and ideally the full Clinical Study Reports. But there have been years of foot-dragging and non-compliance with requirements. We expect doctors and researchers to have access to the best available evidence, not half of it. Government and regulators must listen to what the public thinks about this. It’s a vital matter of public interest for the medicine we have now and the medicines we might have in the future.”
Ben Goldacre: “This problem has been dodged for too long. Over the next two years, many of the drugs in common use will come to the end of their patent life. When that happens, it may become even harder to get the information that has been withheld. By signing the AllTrials petition you can show governments, regulators and research bodies how much this matters, and why they need to act now. Industry and academics must share all trial results: without this information, doctors are misled, and patients are harmed.”
Dr Richard Lehman: “It is a scandal that doctors like myself often prescribe treatments without knowing their true benefits and harms, because research evidence from human trials has been withheld. That means that over my 35 years as a GP, I have unintentionally spent large sums of NHS money on treatments that did not work, and some patients have suffered avoidable harm. We need immediate access to all the data relating to all the drugs and devices which we use on millions of people every day.”
Richard Stephens, Chair of the NIHR Cancer Consumer Liaison Group: “The Department of Health report, Innovation Health and Wealth, sets out a goal for the NHS that every willing patient should be able to take part in research. In our publication, Action On Access, we call for research to be embedded in clinical practice. Already 20% of cancer patients in the UK take part in clinical trials as part of their treatment options. We expect that the results of trials will be made freely available to researchers, clinicians and administrators, in order to deliver better treatments, better services, and better outcomes for patients. So all clinical trials should be on a central accessible register, and all trials should be reporting their results, even if they do not change clinical practice.”
Carl Heneghan, Director, Centre for Evidence-Based Medicine, University of Oxford: “There is a fundamental lack of scientific progress because clinical trial evidence is being withheld. The missing results from the last 20 years also represent lost opportunities to replicate results and learn from all that research, and to develop some of it in light of new discoveries.”
David Tovey, Editor in Chief, The Cochrane Library: “Realism is hugely important in medicine and one of the building blocks of trust between health professionals and the public. Realism depends on researchers, professionals and the public having access to the full picture from all relevant trials. The Cochrane Collaboration conducts systematic reviews to inform decision making, but the process is undermined if our researchers can only access a fraction of the information required.”
Sir Iain Chalmers, Coordinator, James Lind Initiative: “More than 20 years ago the Journal of the American Medical Association published an article written by me entitled ‘Underreporting research is scientific misconduct’. The evidence that has accumulated over the subsequent two decades has made clear that underreporting clinical trials is widespread and constitutes not only scientific misconduct, but also unethical misconduct. The result has been harm to patients and built-in inefficiency in efforts to discover useful and safer treatments.”
A la hora de publicar este post me recuerda @Bibliovirtual la página web The All Results Journals, un proyecto previo que trata de publicar la información no publicada.
Soy médico de familia en Collado Villalba, Madrid. Trato de acompañar a mis pacientes y orientarles ayudado de un equipo de compañeros en el centro de salud y de una potente red profesional en internet. Mi mejor herramienta: la comunicación, la escucha.