Promoting Diversity and Inclusion in Clinical Trials: Insights on the FDORA Initiative

Promoting Diversity and Inclusion in Clinical Trials: Insights on the FDORA Initiative

The underrepresentation of minority populations in clinical trials has been an ongoing issue in clinical research. Many factors compound the problem within the research process that limits the recruitment and participation of diverse populations. Including racial and ethnic minority populations is essential to support science-based approaches to understanding the population’s needs impacted by the condition or disease being studied. Without diversity and inclusion in clinical trials, study findings may not be generalizable to all populations.

The U.S. Food and Drug Administration (FDA) has recognized the need for better representation of subgroups of the population in clinical trials and has subsequently made strides to implement change.

This article will discuss the most recent step in promoting diversity and inclusion in clinical trials and the Food and Drug Omnibus Reform Act (FDORA) initiative. The enactment of the FDA’s new FDORA bill provides guidance on improving clinical trial diversity through a myriad of recommendations for CROs and sponsors. The bill outlines guidance regarding diversity action plans, implementing public workshops, increasing decentralized clinical studies, and modernizing clinical trials. These provisions will require sponsors to create clinical trials that are more inclusive, which will increase participation from underrepresented groups.

FDA’s Previous Attempts to Implement Clinical Trial Diversity

Over the past decade, the FDA has been enacting changes within the biopharma industry to adopt an approach to promote diversity and inclusion in clinical trials. These changes were sparked by a report published in 2013 under the Food and Drug Administration Safety and Innovation Act (FDASIA) section 907, which explored the demographic profile of crucial clinical trials of recently approved medical products. This report revealed what many in the clinical research industry already assumed, that the majority of subject pools did not accurately reflect the distribution of the disease in racial minorities and other disadvantaged populations.

This report provoked the FDA to implement modifications to encourage diversity and inclusion in clinical trials. The FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data was released in 2014. Then, the FDA issued two guidance documents to standardize the collection and reporting of race and ethnicity data in submissions for clinical trials in 2016. One document was aimed at drug studies, while the other was for device studies. The subsequent year, congress executed the FDA Reauthorization Act of 2017 (FDARA). The FDARA required the FDA to publish guidance to promote diversity in clinical trials. In 2020, the guidance was finalized and included inclusive clinical trial practices, trial design and methodological approaches, and broadening trial eligibility criteria using enrichment strategies.

The impacts of the COVID-19 pandemic stopped many trials and altered the clinical trial field. These unique challenges impacted the recruitment of all populations, especially underrepresented groups. Although telehealth provided opportunities to continue accessing clinical trials for some populations, it is unclear if the elderly and disadvantaged had access to these resources. Even with the increased use of telehealth, COVID-19 trials were still found to be inadequately diverse.

In April 2022, the FDA recognized this continued concern and dispatched a draft guidance recommending sponsors develop diversity action plans to improve the enrollment of diverse populations in clinical trials. Now, with the issuance of the FDORA initiative, these plans are mandatory for most clinical trials.

What is the FDORA Initiative?

What exactly is FDORA? The FDORA initiative is a new subsection added to the 505(z) of the Food, Drug, and Cosmetic Act (FDC Act) that requires sponsors and CROs to submit diversity action plans by the time they submit their study protocol. Additional provisions aim to promote diversity and inclusion in clinical trials by modernizing clinical trials by altering patient recruitment, encouraging decentralized clinical trials, and using digital health technologies.

Benefits of the FDORA Initiative

All of the changes set forth by the FDORA initiative are a massive step toward promoting diversity and inclusion in clinical trials. Some of the benefits include:

  • Standardization of the implementation of diversity and inclusion in trials.
  • The new requirement of diversity action plans for all phase III clinical trials.
  • Revised recruitment strategies that specifically target underrepresented populations.
  • Enhanced training and education ensure study teams and investigators are culturally sensitive and competent to engage diverse populations properly. This will help teams better understand the unique challenges minority populations face to develop approaches to address them.
  • Monitoring diversity metrics to ensure studies complies with FDORA. This data will also provide crucial information on assessing the effectiveness of recruitment strategies and guide future changes.
  • Adapting study designs to accommodate the needs of underrepresented populations better. This may include implementing decentralized clinical trials and utilizing digital health technologies.
  • Addressing barriers that diverse populations may face to participate in clinical trials. Breaking barriers might include utilizing decentralized clinical trials and digital health technology.
  • Public workshops where comments can be solicited regarding increasing the enrollment of underrepresented populations in clinical studies. A report must be published on the recommendations raised in the workshop. These recommendations can help guide future studies that anticipate recruiting similar demographic populations.
  • Ensuring compliance by engaging with regulatory authorities. This might include guidance on changing study designs or participating in workshops. These recommendations will promote international coherence.

What is a Diversity Action Plan?

One of the most significant changes mandated by the FDORA initiative is the requirement of submission of a diversity action plan with the study protocol.

Diversity action plans are extremely detailed and must contain the sponsor’s goals for the clinical study enrollment broken down by age group, sex, and racial and ethnic characteristics. Sponsors and CROs must explain the reasoning for their specific enrollment goals and detail the disease or condition and its prevalence or incidence among various demographic groups. The sponsor must also delineate how they intend to meet their goals by including demographic-specific outreach, enrollment strategies, and diversity training for personnel.

The enforcement of diversity action plans are aimed at improving sponsor’s and CRO’s procedures and subsequent completion of recruiting diverse populations during clinical trials. They require sponsors and CROs to think ahead about how they will effectively broaden their pool of participants.

Importance of Adopting Decentralized Clinical Trials

The FDORA initiative encourages decentralized clinical trials to encourage inclusivity and diversity. Decentralized clinical trials allow some or all clinical trial activities to occur at locations other than usual research sites. This can include places like the trial participants’ homes or other local healthcare facilities instead of requiring participants to travel to specified research sites. Follow-up visits might be conducted using telehealth, allowing participants to avoid repeat travel.

The expectation is that by guiding sponsors and CROs to utilize decentralized clinical trials, accessibility will be improved for those with rare diseases, mobility challenges, geographical barriers, and financial constraints.

Utilizing Digital Health Technology to Improve Diversity

The FDORA initiative makes numerous recommendations regarding employing digital health technologies to better include diverse populations. Digital health technologies allow the transmission of data remotely from trial participants wherever they are located. Popular digital health technologies include Electronic Clinical Outcome Assessments (eCOA) and Electronic Patient-Reported Outcomes, patient engagement platforms, and the use of telemedicine.


eCOA/ePRO allows patients to report their outcomes electronically. This drastically reduces the burden on participants while also improving data accuracy.

Patient Engagement Platforms

Patient engagement platforms can also help bridge the communication gap between patients, healthcare providers, and study teams. Sponsors and CROs can use patient engagement platforms to provide personalized support and resources to underrepresented populations, increasing inclusivity. They facilitate information exchange and break down the barriers to care diverse populations often experience.


The application of telemedicine has revolutionized the healthcare industry, so it is no surprise that it is a key player in promoting diversity and inclusion in clinical trials. Allowing televisions for patients located in isolated and underserved areas removes geographical limitations and increases the participation of this rarely included population.

How Do These Changes Impact Regulations?

The FDORA initiative will increase the use of decentralized clinical trials and digital health technologies. These new protocols can create confusion regarding the overlap of the new FDORA guidelines and the common rule and previous FDA requirements. Additionally, the use of digital data collection through digital health technologies is another area of regulation that will require fine-tuning.

FDORA has set a precedent for international standards regarding diversity and inclusivity. Still, foreign regulators must facilitate a mutual understanding of monitoring decentralized clinical trials and digital health technology. When it comes to regulations, there is a great deal of uncertainty regarding who exactly is responsible for the oversight of each trial element, which can make working with a CRO like Vial extremely helpful.

Working Together To Promote Diversity and Inclusion in Clinical Trials

The FDORA initiative urges unity in global regulation to establish a mutual understanding for navigating diversity and inclusion in clinical trials. These guidelines will reduce patient barriers and standardize how sponsors and CROs achieve these goals. The application of diversity action plans, the use of decentralized clinical trials, and digital health technologies will promote diversity and inclusivity and result in improved, more widely applicable treatments worldwide.

By partnering with Vial, biotech companies can access a wealth of expertise tailored to their unique needs. Vial CRO’s mission is to help inspire researchers to uncover groundbreaking scientific therapeutics to help people live healthier and happier lives. Promoting diversity and inclusion in clinical trials is essential to Vial. Vial CRO’s modern, intuitive technology platform integrates trial onboarding, patient enrollment, site communication, and data collection processes into one connected system, allowing for faster, more efficient clinical trials.

Additionally, Vial offers biotech companies a fixed-fee pricing model, which delivers drastically lower costs for biotech companies with smaller budgets. Contact us for additional information on how Vial can support your biotech company.

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