你需要在临床试验?

The world relies on clinical trials to evaluate how safe and effective drugs are before they go to market. But efficacy can vary based on age, race, ethnicity, sex, or other intrinsic factors. This is why diversity matters in clinical research – yet it often isn’t seen.

The challenge is a long standing one, but recent events like the COVID pandemic, social justice movements, and the release of 2020 guidelines by the Food and Drug Administration (FDA) have shined a spotlight on the disparities that persist within clinical trials and other areas of health care.  

“Seeing how the pandemic disproportionately impacted Black and Hispanic communities has really brought more attention around the health equities that are embedded across our health care system, and this is galvanizing people to make a more concerted effort to address them,” said Kim Ribeiro, head of diversity and patient inclusion at AbbVie. “For those of us within the pharmaceutical industry, this is an opportunity to revisit why this is still a problem and what we can do differently.”

参与临床试验应该反映患者人群疾病的影响,但在许多情况下表示不足。AbbVie的多样性和病人包容看需要做什么将来的临床研究工作的进展。

世界依靠临床试验来评估安全有效药物之前他们去市场。但是功效可以随年龄、种族、种族、性别、或其他内在因素。这就是为什么多样性问题在临床研究,但它往往不是。

所面临的挑战是长期的吗,但最近的事件像COVID大流行,社会正义运动,和2020年发布指导方针由美国食品和药物管理局(FDA)已擦亮关注临床试验中存在的差距和其他卫生保健领域。

”看到大流行不成比例的黑人和拉美裔社区的影响确实带来了更多的关注在健康股票嵌入在我们的卫生保健系统,这是镀锌人们做出共同努力解决这些问题,”Kim里贝罗说,AbbVie多样性和耐心包容主管。“对我们这些在制药工业中,这是一个机会重新审视为什么这仍是一个问题,我们能做的不同。”

“While everything else in society is pretty much on-demand, clinical trials are one of the few areas where we’re often asking the patient to come to us. For participants, this may involve taking time off work, traveling and spending long hours at the study site. That’s a hard sell for anyone, especially those who don’t have the luxury of working remotely,” Ribeiro said.

AbbVie worked to address these kinds of barriers while studying uterine fibroids in African American women. In the study, the clinical team had to collect sanitary products participants had used, every single month for over a year. To make the process easier, trial conductors offered transportation assistance, stayed open late and gave patients reminders through a mobile app. These efforts helped keep women on the trial for more than two years.

时间和资源的限制是最常见的障碍病人参与临床研究。

“在一切社会几乎是随需应变,临床试验是为数不多的几个领域,我们经常问病人来找我们。参与者,这可能涉及到请假工作,旅行,花长时间在研究网站。对任何人来说都很难,特别是那些没有奢侈的远程工作,”里贝罗说。

AbbVie致力于解决这些障碍在研究非裔美国女性子宫肌瘤。在这项研究中,临床团队收集参与者使用卫生产品,每个月一年多了。使这个过程更容易,审判导体提供运输援助,一直营业到很晚,给病人通过移动应用程序提醒。这些努力有助于保持女性两年多的试验。

"A lot of times when you talk to patients about considering a clinical trial, it’s very easy for them to articulate the logistical barriers, but emotional barriers are more nuanced," says Sasha Tyndale, director, patient engagement and inclusion solutions, AbbVie.

的后勤障碍、情感障碍时坚持招收人试验。这些类型的障碍可能是受误解的临床试验的价值,医疗行业的不信任或其他的误解。

“很多时候,当你和病人谈谈考虑临床试验,它很容易表达的后勤障碍,但是更微妙的情感障碍,”萨沙廷代尔说,导演,病人参与和包容的解决方案,AbbVie。