"To Share or Not to Share?: Registration and Reporting of Clinical Trial Results"

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The异议竞选(在最近的一次interviewin our online magazineBiome) and books such as Ben Goldacre’s Bad Pharma have brought the issue of registration and reporting of clinical trials into the spotlight. The push for greater transparency continues to gain momentum. Recent discussions around the欧洲药品局(EMA)提案作为标准营销授权申请流程的一部分,主动发布提交给他们的信息进一步使问题成为了最前沿的问题。在EMA完成对申请的决策过程后,提交给EMA的该数据将用于独立重新分析。

Recently, BioMed Central attended apanel discussionOxbridge Biotech Roundtable(OBR) in which panellists, drawn from both academia and industry, discussed registration and reporting of clinical trial results as well as the complicated issue of access to individual participant level data. The panel was moderated by Andrew Jack, Pharmaceuticals Correspondent for theFinancial Times.

Discussions kicked-off with a question on how serious a problem there is with the current level of clinical trial reporting. David Tovey, Deputy CEO and Editor-In-Chief ofCochrane图书馆, feels there is a big problem, and it directly affects patient care. He explained that, since we quantify benefits and harms of specific treatments based on evidence, the absence of full access to the data skews clinical decision making. Systematic reviews, regarded as the highest level of evidence for medical interventions, are undermined when there isn’t full disclosure or data is incompletely reported. Bina Rawal, Director of Medical, Innovation and Research at the英国制药行业协会, thinks the situation is improving and that lessons have been learned; though, Tovey warned that we should not just look prospectively – a patient visiting their doctor today will be prescribed drugs that are available today, not those that may be available in the future. Mahdi Farhan, Group Clinical Director, Roche Products Ltd, added that there are missed opportunities within the pharmaceutical industry to share data with clinicians, researchers and other members of industry.

Panellists were asked whether academics and non-profit organisations should be held to the same level of disclosure as industry and all agreed they should. Deborah Ashby, Professor of Medical Statistics and Clinical Trials and co-Director of帝国临床试验部门explained that the problem is not limited to clinical trials or to industry. To her, the principles are clear:“所有试验,所有数据都应在那里。我们归功于参加的患者;我们归功于未来的患者”,但她补充说“魔鬼在细节上”explaining that there are complex practical issues around responsibility for data from historical trials, infrastructure, andconfidentiality with patient data.

Access to individual patient data is a notoriously tricky issue and discussions moved to who should have access. Panellists were divided on the need for ‘gatekeepers’ vs data being openly accessible. Rawal believes that responsible data sharing involves evaluating the request and the requester and that this is a particular issue with small data sets and rare diseases. Ashby welcomes different people doing different analyses, but cautioned that a delicate balance must be struck between the risk of re-identification from de-identified datasets and the limitations of completely anonymized data sets.

显然,临床试验的注册和报告问题将继续很重要。我们都在提高临床试验中的透明度中发挥作用,并且必须共同努力以确保对临床决策做出全部数据。Biomed Central将继续支持提高透明度的努力,例如通过我们的policy为了注册所有临床试验,ISRCTNregistry service, and publication of负面结果和未完成的研究.

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