論文標題：Adherence to the International Committee of Medical Journal Editors』 (ICMJE) prospective registration policy and implications for outcome integrity: a cross-sectional analysis of trials published in high-impact specialty society journals
期刊：Trails
作者：Anand D. Gopal, Joshua D. Wallach, Jenerius A. Aminawung, Gregg Gonsalves, Rafael Dal-Ré, Jennifer E. Miller and Joseph S. Ross
發表時間：2018/08/23
數字識別碼：10.1186/s13063-018-2825-y
原文連結：https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2825-y?utm_source=WeChat&utm_medium=Website_linksSocial_media_organic&utm_content=CelZha-MixedBrand-multijournal-Multidisciplinary-China&utm_campaign=ORG_AWA_CZH_BMCWechat_dailyposts_blogs
微信連結：https://mp.weixin.qq.com/s/HeWDO4Aev93vwfaYfGT7JQ
原文作者：Anand D. Gopal, Joshua D. Wallach, Jenerius A. Aminawung, Gregg Gonsalves, Rafael Dal-Ré, Jennifer E. Miller and Joseph S. Ross
前瞻性試驗註冊的目的在於發現和預防選擇性報告和發表偏倚。 今天在Trials上發表的一項研究評估了10本高影響力專業醫學團體期刊上發表的多個臨床試驗的註冊情況，作者探討了試驗註冊對醫學領域發展的影響以及我們該如何解決回顧性註冊可能帶來的問題。
我們可能需要為期刊編輯和審稿人制定關於臨床試驗註冊評估更詳細的指南以促進科研透明。
為提高醫學研究的完整性和透明度，前瞻性臨床試驗註冊是大勢所趨。臨床試驗普遍登記有助於發現和預防選擇性（或歪曲）報告，包括未詳細描述的試驗修改和/或在已發表的研究中添加有利的（即統計學有意義的）的結果或去除不利結果。今天發表在Trials上發表的研究評估了10本高影響力專業醫學團體期刊上發表的大量臨床試驗的註冊情況。
2005年，國際醫學期刊編輯委員會（ICMJE）採取了一項鼓勵臨床試驗前瞻性註冊的政策。ICMJE要求所有從2005年7月開始的臨床試驗必須在招募第一個患者時或招募前（即「前瞻性」）進行登記，這一條將作為在ICMJE成員期刊上發表研究的條件。儘管大部分期刊現在都參照ICMJE稿件發表指南，但有證據表明期刊編輯和出版商通常並不能堅持遵循前瞻性註冊的政策。
曾有研究對高影響力綜合醫學期刊所發表試驗的註冊率進行評估，結果表明超過四分之一的已發表試驗進行的是回顧性註冊，這意味著研究人員可以更改研究設計和試驗結果。
雖然現在因為多種舉措的推出，臨床研究註冊和預說明已經變得越來越普遍，但大家對高影響力專業團體期刊上發表試驗的註冊情況仍知之甚少。這些期刊一般由專業組織（如美國神經病學協會（ANA）、美國肝病研究協會（AASLD））管理，通常體現其成員專家的觀點。因此，專家們常常傾向於通過這些期刊了解臨床試驗和相關指南。
Trials最近發表的研究目的在於評估ICMJE前瞻性試驗註冊政策的遵循情況。作者想知道的是，有多少試驗的註冊時間過晚以致於研究人員已有機會對所收集的數據進行初步分析。此外，研究人員還分析了進行前瞻性註冊的試驗都具有哪些特徵，以及註冊和發表的主要結果之間的不同。
研究發現，2010年1月1日至2015年12月31日期間發表在10個影響力最大的美國專業醫學團體期刊上的487項試驗中，近10％未註冊。這些試驗中約有25％進行的是回顧性註冊，其中大部分（68％）註冊的時間比較晚，因而研究人員有機會在登記前對數據進行了初步分析。總體而言，未註冊試驗比註冊試驗更有可能報告有利結果。
期刊是這些研究結果最終的發表渠道，因此期刊在保證研究完整性中扮演了非常重要的角色。此外，專業團體期刊發表的研究通常可能對其目標臨床讀者產生重大影響。因此，這些期刊有責任確保充分且及時的臨床試驗註冊以最大限度地減少結果報告偏差。
為改進現有系統，期刊編輯在評估臨床試驗投稿時需要進行更嚴格的審查。儘管期刊通常要求將公開試驗註冊信息作為同行評議過程的一部分，但研究表明，註冊和報告材料之間的潛在差異不會影響稿件的錄用。在一項對支持ICMJE指南的期刊編輯的調研中，大約三分之二的編輯表示會考慮發表回顧性註冊的臨床研究。
今後可能有必要為期刊編輯、審稿人和作者提供關於臨床試驗註冊評估方面更詳細的指導意見。例如：
1. 在投稿文章中，作者必須明確說明註冊日期；如果是回顧性註冊，也應明確說明。
2. 在同行評審過程中，編輯和/或審稿人應核查試驗進行的前瞻性註冊還是回顧性註冊。
3. 在處理未註冊或回顧性註冊研究時，編輯和/或審稿人應特別注意結果的顯著性（比如，只報告有利結果）。
4. 如果期刊最終決定要發表未註冊或進行回顧性註冊的試驗，則應採取措施確保讀者了解試驗推遲註冊的事實，比如在發表的文章中加入解釋為何沒有註冊/延遲註冊的聲明。
5. 如果期刊最終決定要發表未註冊或進行回顧性註冊的試驗，編輯應要求作者提供原始試驗方案及其後續的修正。如果不能提供這些方案，那文章中應明確說明為什麼無法獲得這些材料。
也許這些措施有助於減少非標準臨床試驗前瞻性註冊的潛在負面影響。總之，此項研究表明，更嚴格地遵循ICMJE試驗前瞻性註冊政策有助於提高臨床研究的完整性和透明度。
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摘要：
Background
Registration of clinical trials is critical for promoting transparency and integrity in medical research; however, trials must be registered in a prospective fashion to deter unaccounted protocol modifications or selection of alternate outcomes that may enhance favorability of reported findings. We assessed adherence to the International Committee of Medical Journal Editors』 (ICMJE) prospective registration policy and identified the frequency of registrations occurring after potential observation of primary outcome data among trials published in the highest-impact journals associated with US professional medical societies. Additionally, we examined whether trials that are unregistered or registered after potential observation of primary outcome data were more likely to report favorable findings.
Methods
We conducted a retrospective, cross-sectional analysis of the 50 most recently published clinical trials that reported primary results in each of the ten highest-impact US medical specialty society journals between 1 January 2010 and 31 December 2015. We used descriptive statistics to characterize the proportions of trials that were: registered; registered retrospectively; registered retrospectively potentially after initial ascertainment of primary outcomes; and reporting favorable findings, overall and stratified by journal and trial characteristics. Chi-squared analyses were performed to assess differences in registration by journal and trial characteristics.
Results
We reviewed 6869 original research reports published between 1 January 2010 and 31 December 2015 to identify a total of 486 trials across 472 publications. Of these 486 trials, 47 (10%) were unregistered. Among 439 registered trials, 340 (77%) were registered prospectively and 99 (23%) retrospectively. Sixty-seven (68%) of these 99 retrospectively registered trials, or 15% of all 439 registered trials, were registered after potential observation of primary outcome data ascertained among participants enrolled at inception. Industry-funded trials, those with enrollment sites in the US, as well as those assessing FDA-regulated interventions each had lower rates of retrospective registration. Unregistered trials were more likely to report favorable findings than were registered trials (89% vs. 64%; relative risk (RR) = 1.38, 95% confidence interval (CI) = 1.20–1.58; p = 0.004), irrespective of registration timing.
Conclusions
Adherence to the ICMJE’s prospective registration policy remains sub-standard, even in the highest-impact journals associated with US professional medical societies. These journals frequently published unregistered trials and trials registered after potential observation of primary outcome data.
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https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2825-y?utm_source=WeChat&utm_medium=Website_linksSocial_media_organic&utm_content=CelZha-MixedBrand-multijournal-Multidisciplinary-China&utm_campaign=ORG_AWA_CZH_BMCWechat_dailyposts_blogs
期刊介紹:
Trials(https://trialsjournal.biomedcentral.com/, 2.067 - 2-year Impact Factor, 2.343 - 5-year Impact Factor) encompasses all aspects of the performance and findings of randomized controlled trials in health. We publish articles on general trial methodology and research into trial processes, as well as study protocols and statistical analysis plans for randomised controlled trials, commentaries and traditional results papers - regardless of outcome or significance of findings.
（來源：科學網）
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