5,301名美国女性调查:仅11%曾受邀参加临床试验、7%真正入组,88%支持在研究中纳入女性并按性别报告结果

《科学报告》11月7日发表 Fida、Rajasekera、Roy 等作者的论文《理解美国女性参加临床试验的障碍:一项全国调查研究》。研究对5,301名18至70岁的美国女性进行了全国横断面在线调查,评估其参加临床试验的意愿(WTP)、既往经历,以及对研究中性别差异的认知。作者指出,女性,尤其是少数族裔女性,在临床研究中长期代表性不足,而她们自身对参与的看法此前缺乏系统刻画。
结果方面,在报告了族裔的4,987名受访者中,白人占77%、黑人占14%、亚裔占7%、其他占2%。多数人至少表达了试探性兴趣:23%回答「肯定愿意」、60%回答「也许愿意」;但只有11%的人曾被邀请参加临床试验,真正入组过的只有7%。调整后模型显示,黑人女性的参与意愿低于白人女性(β=−0.4,P=0.0003),而受教育程度更高、患有多种疾病者意愿更高。另有88%的受访者支持在临床研究中纳入女性并进行按性别的结果报告。
作者据此写道,受邀机会有限,加上结构性与信息性障碍,可能共同造成女性参与率偏低;论文提出,应评估以女性需求为中心的建立信任、减轻负担与文化适配的参与策略,并把强调研究的性别相关性作为一种待检验的招募办法。该研究为横断面调查,反映的是受访者自报意愿与经历,不直接证明因果关系;论文为正式发表的同行评审论文。
(来源:《科学报告》)
In a National Survey of 5,301 U.S. Women, Only 11% Had Ever Been Invited Into a Clinical Trial and 7% Had Enrolled, While 88% Backed Including Women and Sex-Specific Reporting
A paper published in Scientific Reports on November 7 by Fida, Rajasekera, Roy and colleagues, titled "Understanding barriers to clinical trial participation among U.S. women: a national survey study," reports a national cross-sectional online survey of 5,301 U.S. women aged 18-70, assessing willingness to participate (WTP), experiences with clinical trials, and awareness of sex-based differences in relation to research engagement. The authors note that women, particularly those from racially and ethnically minoritized groups, remain underrepresented in clinical research, while their own perspectives on participation are not well characterized.
Among the 4,987 respondents reporting race, 77% White, 14% Black, 7% Asian and 2% Other, most expressed at least tentative interest: 23% said "definitely" and 60% "maybe." Yet only 11% had ever been invited to take part in a clinical trial and only 7% had enrolled. In adjusted models, willingness to participate was lower among Black women than among White women (β = -0.4; P = 0.0003), while higher educational attainment and multimorbidity predicted greater willingness. In addition, 88% of respondents endorsed women's inclusion and sex-specific reporting in clinical research.
The authors conclude that limited invitation, together with structural and informational barriers, may contribute to women's low participation, and they support evaluating trust-building, burden-reducing and culturally responsive strategies centered on women's needs, including emphasizing the sex-specific relevance of research as an engagement strategy to be tested. The study is cross-sectional and rests on self-reported willingness and experience; it does not establish causation. The paper is formally published and peer-reviewed.
(Source: Scientific)
来源:《科学报告》
发布:GSM·美国(发布链接)
图片来源:图:临床试验志愿者接受检查(资料图)。CC BY 2.0,经 Wikimedia Commons。 / Photo: A clinical trial volunteer being examined (file photo). CC BY 2.0, via Wikimedia Commons.
GSM Global · 本篇英文版 English edition of this story

