Pfizer Inc, 300 Technology Square, Cambridge, MA 02138, United States of America.
Pfizer Inc, 445 Eastern Point Rd, Groton, CT 06340, United States of America.
Contemp Clin Trials. 2021 Jul;106:106421. doi: 10.1016/j.cct.2021.106421. Epub 2021 Apr 30.
The approval of new medicinal agents requires robust efficacy and safety clinical trial data demonstrated to be applicable to population subgroups. Limited data have previously been reported by drug sponsors on the topic of clinical trial diversity. In order to establish a baseline of diversity in our clinical trials that can be used by us and other sponsors, an analysis of clinical trial diversity was conducted covering race, ethnicity, sex, and age. This analysis includes Pfizer interventional clinical trials that initiated enrollment between 2011 through 2020. The data set comprises 213 trials with 103,103 US participants. The analysis demonstrated that overall trial participation of Black or African American individuals was at the US census level (14.3% vs 13.4%), participation of Hispanic or Latino individuals was below US census (15.9% vs 18.5%), and female participation was at US census (51.1% vs 50.8%). The analysis also examined the percentage of trials that achieved racial and ethnic distribution levels at or above census levels. Participant levels above census were achieved in 56.1% of Pfizer trials for Black or African American participants, 51.4% of trials for White participants, 16.0% of trials for Asian participants, 14.2% of trials for Native Hawaiian and Pacific Islander participants, 8.5% of trials for American Indian and Alaska Native participants, and 52.3% of trials for Hispanic or Latino participants. The results presented here provide a baseline upon which we can quantify the impact of our ongoing efforts to improve racial and ethnic diversity in clinical trials.
新药物的批准需要强有力的疗效和安全性临床试验数据，这些数据必须证明适用于人群亚组。此前，药物赞助商在临床试验多样性方面的报告数据有限。为了在我们的临床试验中建立多样性基准，以便我们和其他赞助商使用，我们对临床试验多样性进行了分析，涵盖了种族、民族、性别和年龄。该分析包括辉瑞公司在 2011 年至 2020 年间启动入组的干预性临床试验。该数据集包含 213 项试验，共有 103,103 名美国参与者。分析表明，黑人或非裔美国人的总体试验参与率与美国人口普查水平相当（14.3%比 13.4%），西班牙裔或拉丁裔的参与率低于美国人口普查水平（15.9%比 18.5%），女性参与率与美国人口普查水平相当（51.1%比 50.8%）。该分析还检查了达到或超过人口普查水平的种族和民族分布水平的试验比例。在辉瑞公司的试验中，黑人或非裔美国参与者的试验水平达到或超过人口普查水平的比例为 56.1%，白人参与者的试验水平为 51.4%，亚洲参与者的试验水平为 16.0%，夏威夷原住民和太平洋岛民参与者的试验水平为 14.2%，美洲印第安人和阿拉斯加原住民参与者的试验水平为 8.5%，西班牙裔或拉丁裔参与者的试验水平为 52.3%。这里呈现的结果为我们提供了一个基准，我们可以用它来量化我们正在努力改善临床试验中种族和民族多样性的影响。
