Nordic Cochrane Centre, Rigshospitalet 7811, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Syst Rev. 2018 Jan 18;7(1):8. doi: 10.1186/s13643-018-0675-z.
Unabridged access to drug industry and regulatory trial registers and data reduces reporting bias in systematic reviews and may provide a complete index of a drug's clinical study programme. Currently, there is no public index of the human papillomavirus (HPV) vaccine industry study programmes or a public index of non-industry funded studies.
By cross-verification via study programme enquiries to the HPV vaccine manufacturers and regulators and searches of trial registers and journal publication databases, we indexed clinical HPV vaccine studies as a basis to address reporting bias in a systematic review of clinical study reports.
We indexed 206 clinical studies: 145 industry and 61 non-industry funded studies. One of the four HPV vaccine manufacturers (GlaxoSmithKline) provided information on its study programme. Most studies were cross-verified from two or more sources (160/206, 78%) and listed on regulatory or industry trial registers or journal publication databases (195/206, 95%)-in particular, on ClinicalTrials.gov (176/195, 90%). However, study results were only posted for about half of the completed studies on ClinicalTrials.gov (71/147, 48%). Two thirds of the industry studies had a study programme ID, manufacturer specific ID, and national clinical trial (NCT) ID (91/145, 63%). Journal publications were available in journal publication databases (the Cochrane Collaboration's Central Register of Controlled Trials, Google Scholar and PubMed) for two thirds of the completed studies (92/149, 62%).
We believe we came close to indexing complete HPV vaccine study programmes, but only one of the four manufacturers provided information for our index and a fifth of the index could not be cross-verified. However, we indexed larger study programmes than those listed by major regulators (i.e., the EMA and FDA that based their HPV vaccine approvals on only half of the available trials). To reduce reporting bias in systematic reviews, we advocate the registration and publication of all studies and data in the public domain.
未删减的药物行业和监管试验注册和数据可以减少系统评价中的报告偏倚，并可能为药物的临床研究计划提供完整索引。目前，没有公开的 HPV 疫苗行业研究计划索引，也没有非行业资助研究的公开索引。
通过向 HPV 疫苗制造商和监管机构发送研究计划查询，并搜索试验注册和期刊出版物数据库，我们对 HPV 疫苗临床研究进行了索引，以此为基础来解决 HPV 疫苗临床研究报告系统评价中的报告偏倚问题。
我们对 206 项临床研究进行了索引：145 项行业资助研究和 61 项非行业资助研究。四家 HPV 疫苗制造商中的一家（葛兰素史克）提供了其研究计划的信息。大多数研究通过两个或更多来源进行了交叉验证（160/206，78%），并在监管或行业试验注册或期刊出版物数据库中列出（195/206，95%）-特别是在 ClinicalTrials.gov（176/195，90%）。然而，只有大约一半的已完成研究在 ClinicalTrials.gov 上公布了研究结果（71/147，48%）。三分之二的行业研究具有研究计划 ID、制造商特定 ID 和国家临床试验（NCT）ID（91/145，63%）。期刊出版物可在期刊出版物数据库（Cochrane 协作中央对照试验注册库、Google Scholar 和 PubMed）中获得已完成研究的三分之二（92/149，62%）。
我们相信我们已经接近索引完整的 HPV 疫苗研究计划，但只有四家制造商中的一家提供了我们索引的信息，并且有五分之一的索引无法进行交叉验证。然而，我们索引的研究计划比主要监管机构（即基于可用试验仅批准一半的 EMA 和 FDA）列出的研究计划更大。为了减少系统评价中的报告偏倚，我们提倡将所有研究和数据在公共领域注册和公布。
