Diversity & Inclusion in Clinical Trials
支持多样性行动计划
We can help you meet regulatory requirements and ensure that therapies are developed in a population with demographic characteristics of the intended use population in the real world.
Proven experience
Meet Diversity Action Plan requirements with the team that has completed ~15% of the drug products and medical device plans submitted to the FDA thus far.
Expert support
Advance your negotiations with regulators for concurrence on your Diversity Action Plan.
Powerful technology
Leverage in-study diversity insights with the Fortrea Diversity and Inclusion Study Insights Dashboard.
Leading the way on Diversity Action Plans
On June 26, 2024, the U.S. FDA’s draft guidance on improving diversity was published: Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. This draft guidance is now open for comments through September 26, 2024. Until the final version is published, it replaces the FDA’s previous guidance published in April 2022.
The Fortrea Regulatory Strategy Consulting team closely tracks the U.S. regulatory landscape to understand how other regulatory agencies (e.g., EMA and MHRA) are working to meaningfully improve the diversity of clinical trial participants in global studies.
Creating solutions beyond the plan
We write and support the implementation of Diversity Action Plans that set diversity goals and help eliminate gaps in participation. Throughout your clinical development, we are an extension of your team to support your diversity goals and inclusion practices. With our unique combination of consulting services, mobile and digital capabilities, strong investigator site network and our innovative Diversity and Inclusion Insights Dashboard, we're ready to enable greater patient access and improve healthcare for all.
Upgrade your diversity planning with real-world data
Our experts help you set realistic diversity goals. 多样性计划从详尽的流行病学评估开始，采用真实世界数据和文献来确定疾病在目标患者群体中的流行情况。 Our experts then consult to understand the requirements, applicability to your program and map out a path forward.
Locate, attract and retain—bringing your plan to life
With access to multiple data platforms, our Site Advisory Board and technology-enabled solutions, our team identifies where diverse patients are located and implements strategies to attract and retain them.
Supporting regulatory interactions
您的多样性行动计划是一套动态文件。在研究和项目过程中，我们持续收集指标、撰写报告并按需支持您与监管方的沟通。
Fortrea多样性和包容性研究洞察板
Leverage powerful, in-study diversity insights and end-of-study reporting
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In-study enrollment monitoring
To help ensure your study is reflective of a real-world population, we provide in-study enrollment monitoring of the predefined demographic and non-demographic characteristics of participants. From study startup through conduct and closeout, our proprietary dashboard can:
- 按种族、年龄、性别和族裔分析数据，以帮助确定具有人口针对性的标志
- 根据入组被试者的主要参数资料，评估研究药物的安全性和有效性
- 审核不同分组/试验现场的任何被试者退出和失访病例，以改进您的保留策略
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A real-time view of current trends
With powerful, in-study diversity data from the dashboard, you’ll have a real-time view of current trends in your trial so you can:
- 做出知情决策，评估您的多样性行动计划的影响力
- 调整您的入组和保留策略
- 采取矫正行动
- 生成报告，以支持持续的法规互动和报告提交