Celebrating International Clinical Trials Day

On May 20, 1747,James Lindpioneered a scurvy trial on board the HMS Salisbury. Providing some crew members with two oranges and one lemon per day, while others were given cider, vinegar, sulphuric acid or seawater, along with their normal rations, Lind’s experiment is ranked as one of the first clinical trials in the history of medicine. More than 250 years later, the anniversary of his groundbreaking work is celebrated asInternational Clinical Trials Day。林德(Lind)工作原则每年由美国国家卫生研究所(National Shealth Research)举行,仍然是现代临床试验的基础。

In acommentary为了试验,Dr David Sackett他对临床试验的最新发展提供了他的观点,评估了过去十年中发生的变化,并考虑了试验实践的未来。One noticeable change, Dr Sackett notes, is that patients are becoming ever more informed and demanding: ‘Patient groups are increasingly holding trialists’ feet to the fire and forcing us to honour our obligations to them and their diseases, illnesses, predicaments, and other patient-relevant outcomes, rather than focusing only on our interests and those of the drug and device industries.’ The commentary also highlights the growing number of trials conducted in the developing world by trialists hailing from those regions, and the higher levels of recognition this research is receiving.

The future of clinical trials looks positive, not least in the way trial results are used. Just as registering clinical trials has become the norm, there are calls for the publication of all trial results (regardless of outcome) to be an established practice. TheAlltrials倡议, launched in January 2013, is gathering pace, gaining support from the European Medical Agency, many patient groups, and ‘big pharma’ giants, most notably GlaxoSmithKline which is now dedicated to releasing all of its trial results online. The shift towards publication of all results is an important one in the eyes of many researchers. A combination of journals dedicating publication space to more interesting positive findings, and reticence on the part of researchers to publish unwelcome results has led to publication bias and a wider distrust among doctors and patients as to whether the interventions they are prescribing and taking are really the best for the patient. In a Q&A withBiome, the new online magazine from BioMed Central,Dr Ben GoldacreAllTrials倡议的创始人之一,进行初步的探讨s the campaign, and how it can dramatically change the landscape of trial reporting. Dr Goldacre comments that ‘doctors, patients, payers, and researchers need access to all the results, of all the trials that have been conducted on a treatment, in order to make informed decisions about which is best. The idea that trial results should be withheld is ludicrous, it simply breaks evidence based medicine, and exposes the medical profession to justified mockery.’

The shift towards publication of all results can be seen as part of a wider move towards making research more available to an increasingly educated public, as well as those researchers and clinicians that directly use results from such research. Last year, the UK government commissioned theFinch report, which advised parliament to demand that all research funded by public money be published as either ‘green’ or ‘gold’ open access. Universities and science minister, David Willets, promptlymade the announcementthat £10 million would be earmarked to aid the introduction of such a policy.

As a pioneer of open access, BioMed Central has seen the benefits that opening up research can bring. Tapping into the need for more transparency in clinical trails, the journal试验以及发布试验和试验方案的所有其他生物元期期刊,要求作者注册其临床试验作为提交条件。为此,中央奔跑当前的对照试验on the behalf of ISRCTN, the UK’s trial registration service. To date, the register holds records of over 11,500 trials. BioMed Central also welcomes theHRA proposals“将临床试验的注册在约定的时间范围内成为伦理批准的条件”,并与出版商合作,以消除对发布结果的困难的神话和看法”。

负面结果的发布是在研究人员,尤其是审判者中受到更多关注。试验期刊支持出版负面结果,以及Journal of Negative Results,为发布意外结果或与当前理解相抗衡的唯一目的而建立。

Today, billions of people across the globe will take drugs – from paracetamol tablets to anti retrovirals – that are life saving and life enhancing, and that have all been through a lengthy process of intense testing. Over a quarter of a millennium researchers have refined this process, and continue to do so today, ensuring that the work James Lind began on the HMS Salisbury endures.

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