Linking Regulations with Diversity, Inclusion, and New Opportunities in Decentralized Clinical Trials
Isaac R. Rodriguez-Chavez

raditional clinical trials have created a series of deficiencies in diversity and inclusion (D&I). Decentralized clinical trials (DCTs) enabled by digital health technologies (DHTs) offer new opportunities to improve D&I. These trials offer advantages driven by increasing convenience for participants by breaking geographic barriers with the use of technology. However, the implementation of these trials alone will not be enough to address D&I deficiencies. Multipronged approaches are needed to overcome barriers and to realize the benefits of enhancing D&I in DCTs enabled by DHTs. These approaches should include D&I plans at the regulatory, organizational, and trial participant level.

Barriers to D&I in Traditional Clinical Trials

Traditional clinical trials have failed to enroll and retain diverse populations that reflect global trends and changes in the composition of racial and ethnic minorities and underrepresented populations. Reported D&I barriers include:

  • differences in socioeconomic strata of minority populations and access to trials,
  • unconscious bias and lack of cultural competencies among trial personnel,
  • lack of trust by minority populations, and
  • recruitment and retention hurdles, such as not targeting diverse populations, not enhancing screening pools, and not having acceptable transition of eligible to enrolled minorities.

The lack of D&I in traditional clinical trials has compromised the generalizability of results due to multiple sources of bias. Important knowledge has also been missed about the benefits and risks of administering novel medical products in minority populations. The lack of diversity among trial personnel has even created gaps in asking key health-related questions in diverse populations.

Benefits of D&I in Traditional and Modern Clinical Trials

Diversity drives quality in clinical research. It comprises characteristics such as race, ethnicity, gender, geographic location, socioeconomic status, cultural practices and beliefs, sexual orientation, and religion and class identity differences. Inclusion involves appreciating the contributions, presence, and perspectives of different groups of people and integrating them into an environment. Reported D&I benefits include:

  • allowing sponsors and investigators to more accurately test the safety and efficacy of novel medical products in diverse populations where these medical products will be used,
  • increased pool of individuals to be considered in clinical research,
  • opportunity to address health disparities and to aim at equity,
  • improved trust in clinical trials by diverse populations who can benefit from participating, and
  • enhanced new perspectives and innovation by including diverse personnel.

The benefits generated by implementing D&I strategies in DCTs enabled by DHTs are clear to all parties involved – including sponsors, trial personnel, trial participants, organizations, and societies at large.

To overcome the lack of D&I in DCTs enabled by DHTs going forward, multipronged approaches at different levels are needed, including at the regulatory, organizational, clinical team, and trial participant level.

Regulatory Level

In the US, the federal government has implemented a series of regulatory actions to overcome D&I deficiencies. However, these efforts should continue to address multiple dimensions related to the implementation of DCTs enabled by DHTs and the accessibility by diverse populations. Some of these regulatory actions include the following:

  • The National Institutes of Health’s 1993 Revitalization Act led to a policy on the inclusion of women and minorities as participants in clinical trials.
  • The Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) of 2012 set expectations for, but did not demand, sponsors to include greater representation of diverse trial participants relative to age, gender, race, and ethnicity in biomedical research.
  • Women’s Health Research Roadmap implemented by the FDA in December 2015 established a strategic framework for research funded by the FDA Office of Women’s Health.
  • Collection of Race and Ethnicity Data in Clinical Trials, Guidance for Industry and FDA Staff (2016) provided FDA expectations for and recommendations on the use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA-regulated medical products.
  • FDA Diversity and Inclusion Strategic Plan (2018 – 2021) promoted D&I at the FDA workplace.
  • FDA Reauthorization of PDUFA Act (2017) provided greater authority to address possible barriers in recruiting appropriate patient populations.
  • Enhancing the Diversity of Clinical Trial Populations, Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry (2020) recommended approaches that sponsors of clinical trials should take to increase enrollment of underrepresented populations in their clinical trials.

Organizational and Clinical Trial Team Level

The multiple dimensions of D&I at the organizational and trial team level include a diagnostic assessment of D&I gaps based on diversity composition, inclusion in the workplace, performance indicators of personnel, and inclusion competency metrics. It also includes an understanding of inclusion challenges, followed by sensible actions to improve organizational and trial team diversity. It entails developing a strategy and a tracking system to map out D&I status, focus on specific areas of enhancement, and create engagement and reward incentives based on performance. Some of the D&I at this level include:

  • implementing learning opportunities about implicit bias, health disparities, inequities, advocacy, and the need for D&I in clinical research;
  • enhancing training strategies to increase cultural competencies and to identify and overcome implicit racial and gender biases in personnel interactions with trial participants;
  • strengthening organizational commitment and accountability by creating D&I values and leadership competencies; and
  • establishing D&I in the workforce, trial team, and in the development of future leaders.

Trial Participant Level

The inclusion of diverse populations in traditional and modern clinical research should be at the front and center because it is ethically correct, the right equity action, and medically necessary. This perspective includes:

  • educating and training trial participants, reflecting contemporary D&I of societies;
  • using cultural competency approaches to conduct customized outreach strategies for minorities and underrepresented populations;
  • ensuring that lack of access to technology, technology services (e.g., internet), healthcare, transportation, and socioeconomic factors does not represent barriers to trial participation.

In summary, implementing multipronged approaches in modern trials like DCTs enabled by DHTs can greatly reduce past D&I failures of traditional clinical trials and will require actions at the regulatory, organizational, and trial participant level.