Pfizer Inc, 10777 Science Center Dr, San Diego, CA 92121, USA.
Pfizer Inc, 445 Eastern Point Rd, Groton, CT 06340, USA.
Contemp Clin Trials. 2022 Jul;118:106807. doi: 10.1016/j.cct.2022.106807. Epub 2022 May 27.
Increasing the diversity of participants in clinical trials is important as it allows further examination of drug effects in all subgroups of patients who will be prescribed an approved medicine. It also gives patients more confidence in the medicine when they know that individuals similar to themselves have participated in pivotal efficacy and safety trials. Pfizer recently committed to ensuring that its clinical trials reflect racial and ethnic demographics of the patient populations in the countries and communities in which the trials are conducted. This paper furthers Pfizer's commitment by declaring what Clinical Pharmacology (CP) can do to advance this goal and expand patient populations to include other groups such as pediatrics, elderly, and those with organ impairment. This includes steps such as: Pfizer Clinical Pharmacology commits to these actions, which create a framework for the CP Community to enable increased diversity among participants in clinical trials and improved dosing recommendations for all patient subgroups.
增加临床试验参与者的多样性很重要,因为这可以进一步检查所有将被开处批准药物的患者亚组的药物效果。当患者知道与自己相似的个体已经参与了关键疗效和安全性试验时,他们也会对药物更有信心。辉瑞公司最近承诺确保其临床试验反映出试验所在国家和社区的患者人群的种族和民族人口统计学特征。本文通过宣布临床药理学(CP)可以采取哪些措施来推进这一目标,并扩大患者群体,包括儿科、老年患者和器官损伤患者等其他群体,进一步推进了辉瑞公司的承诺。这包括采取以下步骤:辉瑞临床药理学承诺采取这些行动,为 CP 社区创建一个框架,使临床试验中的参与者更加多样化,并为所有患者亚组提供更好的剂量建议。