Kanji Salmaan, Hayes Meghan, Ling Adam, Shamseer Larissa, Chant Clarence, Edwards David J, Edwards Scott, Ensom Mary H H, Foster David R, Hardy Brian, Kiser Tyree H, la Porte Charles, Roberts Jason A, Shulman Rob, Walker Scott, Zelenitsky Sheryl, Moher David
Department of Pharmacy, The Ottawa Hospital and Ottawa Hospital Research Institute, 501 Smyth Rd, Ottawa, ON, K1H 8L6, Canada,
Clin Pharmacokinet. 2015 Jul;54(7):783-95. doi: 10.1007/s40262-015-0236-8.
Transparent reporting of all research is essential for assessing the validity of any study. Reporting guidelines are available and endorsed for many types of research but are lacking for clinical pharmacokinetic studies. Such tools promote the consistent reporting of a minimal set of information for end users, and facilitate knowledge translation of research. The objective of this study was to create a guideline to assist in the transparent and complete reporting of clinical pharmacokinetic studies.
Preliminary content to be considered was identified from a systematic search of the literature and regulatory documents. Stakeholders were identified to participate in a modified Delphi exercise and a virtual meeting to generate consensus for items considered essential in the reporting of clinical pharmacokinetic studies. The proposed checklist was pilot tested on 100 recently published clinical pharmacokinetic studies. Overall and itemized compliance with the proposed guidance was determined for each study.
Sixty-eight stakeholders from nine countries consented to participate. Four rounds of a modified Delphi survey and a series of small virtual meetings were required to generate consensus for a 24-item checklist considered to be essential to the reporting of clinical pharmacokinetic studies. When applied to the 100 most recently published clinical pharmacokinetic studies, 45 were determined to be compliant with at least 80 % of the checklist items. Explanatory text was prepared using examples of compliant reporting from these and other relevant studies.
The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these studies and allow for better assessment of utility for clinical applications.
所有研究的透明报告对于评估任何研究的有效性至关重要。许多类型的研究都有可用且得到认可的报告指南，但临床药代动力学研究却缺乏此类指南。此类工具促进为最终用户一致报告最少的信息集，并有助于研究成果的知识转化。本研究的目的是创建一项指南，以协助临床药代动力学研究进行透明且完整的报告。
通过对文献和监管文件的系统检索确定要考虑的初步内容。确定利益相关者参与改进的德尔菲法练习和虚拟会议，以就临床药代动力学研究报告中被视为必不可少的项目达成共识。在100项最近发表的临床药代动力学研究中对拟议的清单进行预试验。确定每项研究对拟议指南的总体和逐项合规情况。
来自9个国家的68名利益相关者同意参与。需要进行四轮改进的德尔菲调查和一系列小型虚拟会议，以就一份被认为对临床药代动力学研究报告至关重要的24项清单达成共识。当应用于100项最近发表的临床药代动力学研究时，确定有45项至少符合清单项目的80%。使用这些及其他相关研究的合规报告示例编写了解释性文本。
研究信息报告不完整会极大地损害读者判断药代动力学研究有效性的能力。我们采用共识方法开发了一种工具，以指导临床药代动力学研究进行透明且准确的报告。研究人员、临床医生和期刊对这些指南的认可和实施将促进这些研究报告更加一致，并有助于更好地评估其临床应用价值。
