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A discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.

When Should the Audit Trail Begin?

Video interview with Sepehr Shojaei, VP, Design Solutions, Lightship

Lightship's Approach to Accessible, Representative, and Impactful Clinical Trials

Lightship prioritizes patient accessibility and centricity in clinical trials, ensuring a seamless and positive experience for every participant. Learn more about:

Lightship's mission and core purpose as a company

How Lightship’s mobile nursing teams and home visits enhance study participation and retention

The role of mobile research units in the community and how they enhance participant education, accessibility, and convenience

Sepehr Shojaei, VP of Design Solutions at Lightship, talks about how the company works with pharma and contract research organization (CRO) partners to support clinical trials that are patient-first and accessible.

Latest Conference Coverage

Lightship’s Approach to Accessible, Representative, and Impactful Clinical Trials

Video interview with David MacMurchy, CEO of Lightship

Accelerate Inclusive Enrollment and Delivery with Lightship

Lightship focuses on patient accessibility and centricity in clinical trials, ensuring the patient experience is a positive one. Learn more about:

Lightship's impact on achieving diversity in clinical trials by engaging underrepresented patient populations

How Lightship utilizes hybrid and decentralized trial designs to reduce patient burden

The impact a patient centric model has on clinical trial participation and outcomes

David MacMurchy, Chief Executive Officer at Lightship, offers some insights into the company's mission toward improving equity and diversity in clinical trials. 

Focus on biotech: Harnessing FSP engagements to deliver on-time, on-budget

The FDA has increasingly issued guidelines and set expectations for industry to enroll clinically relevant and diverse trial populations.

 Prior to the enactment of legislation through the Food and Drug Omnibus Reform Act of 2022, there were no widespread mandates requiring representative enrollment in industry-sponsored studies. In fact, during a cross-sector clinical research meeting in 2011, representatives stated industry would take initiative and strive to improve the representativeness of clinical research without the need for regulatory mandates.

 It appears that many key players in the clinical trial ecosystem did exactly that—implementing policies and practices that directly or indirectly support more inclusive and representative clinical trials, such as:

 began requiring authors to report on disease background and study population representativeness—an approach now adopted by many journals.

 Launched in 2012, the FDA’s Patient-Focused Drug Development (PFDD) program introduced patient listening sessions and industry guidance for incorporating patient voice into medical product development.

 Although PFDD began in response to a congressional mandate under FDASIA, FDA remained committed to enhancing this initiative.

Guided by the PFDD framework, advocacy groups have led over 100 externally hosted patient listening sessions.

Companies such as Bristol Myers Squibb have set goals to conduct trials at sites located in racially and ethnically diverse metro areas to improve accessibility.

Federal policy on trial participation coverage.

 US policy now requires Medicare, all state Medicaid programs, and private insurers to cover routine care costs for trial participants.

Cross-sector partnership launches EQBMED.

 Initially funded by PhRMA and established as a cross-sector collaborative, Equitable Breakthroughs in Medicine Development (EQBMED) launched a pilot to develop an infrastructure of community-based trial sites.

 Many health systems have adopted diversity, equity, and inclusion (DEI) and health equity programs to better reflect and partner with their communities.

 The Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard has issued guidance and toolkits to promote representation in research across dimensions such as race, ethnicity, disability, LGBTQIA+ identity, and more.

Meanwhile, mandates for clinical trial diversity are beginning to take effect. Unless modified, the current legislation enacted under FDORA will soon require sponsors to submit diversity action plans (DAPs) to the FDA for all pivotal studies.

 Encouragingly, many sponsors have already begun submitting DAPs voluntarily ahead of these statutory requirements.

DAPs offer a valuable framework for proactively planning inclusive research across the development lifecycle and should be considered best practice—regardless of legal obligation. They can guide trial design, site selection and staff training, culturally tailored recruitment and retention strategies, and ongoing engagement.

We appear to be moving in the right direction toward sustainable change in clinical trial inclusivity—even in the absence of mandatory policies. According to various published reports, clinical trials supporting FDA approvals have shown progress in demographic diversity, with increased representation of women, older adults, and Black participants, and a decline in White overrepresentation—dropping below 75% by 2020.

However, representation remains inconsistent across studies, with some populations over- or underrepresented depending on the condition and benchmark used.

Despite ongoing variability in enrollment by demographic subgroup, progress is evident compared to 2011, when 83% of participants in domestic industry-funded trials were reportedly non-Hispanic White.

 However, much of the focus to date has been on demographic characteristics. At a 2024 National Academies of Sciences, Engineering, and Medicine workshop, FDA and NIH leaders acknowledged progress in racial, ethnic, and sex-based inclusion, but emphasized that representation remains lacking across a broader spectrum, including rural populations, older adults, Indigenous peoples, people with disabilities, and sexual and gender-diverse individuals.

In January 2025, new disruptions emerged with the administration’s executive orders and efficiency measures—banning DEI initiatives, threatening investigations into “illegal DEI practices” in the private sector, significantly cutting funding for research grants, and eliminating or downsizing several Health and Human Services divisions focused on addressing health disparities.

Staffing and policy changes at the FDA, along with efforts to lower prescription drug costs, have prompted some biotech companies to move early-stage trials overseas and may discourage investment in innovation and additional indications—leading to fewer opportunities to offer clinical research as a care option.

 Collectively, these shifts threaten to erode progress in inclusive research—reducing investments in innovation, narrowing patient access, and weakening the infrastructure needed to sustain equitable participation—and, more broadly, pose risks to clinical development that depend on diverse participation for real-world relevance.

These are not the policies the clinical trial ecosystem had hoped for.

While policy should support rather than hinder progress, the question remains whether mandates are truly effective. Although the NIH has required the inclusion of women and members of diverse groups and their subpopulations—distinguished by racial, ethnic, or cultural heritage—in NIH-funded clinical research since the 1993 Revitalization Act, many researchers fall short in planning how to meet these goals.

Many NIH-funded principal investigators do not establish recruitment goals for all demographic subgroups, suggesting a lack of intentional planning. In one study, published in 

, fewer than 3% of National Heart, Lung, and Blood Institute-funded researchers set goals for all demographic groups and were more likely to miss goals for Black (51%), Asian (55%), and Hispanic (44%) participants than for White participants (30%). In a related study, published in 

, only 36% required cultural competency training for site staff, despite recommending it as a best practice.

The implications are clear: disparities in trial participation persist in NIH-funded research. Participant demographics vary widely across NIH institutes and centers, with Hispanic individuals appearing to be the most underrepresented.

 Trends from National Cancer Institute trials between 2005 and 2020 show lower participation by older adults, women, Asian or Pacific Islander, American Indian or Alaska Native, and Hispanic individuals compared with their representation in the US cancer population.

NIH initiatives, however, demonstrate how accountability can drive inclusive research practices. For example, to maintain federal designation, Alzheimer’s disease research centers must engage in ongoing community education—reaching diverse populations, including non-English speakers.

Community-building efforts such as those from EQBMED and other sponsor—or site-led initiatives—are expanding but more efforts are needed. Sponsors and CROs could adopt a points-based system for site efforts and allocate resources to support site-level community engagement. NIH also requires institutional review boards to consider both its inclusion policy and the FDA’s (now-withdrawn) guidance on evaluating gender differences in drug research.

Amid uncertain regulatory expectations, many leading organizations are setting the standard by integrating inclusive practices into their trial operations. To drive meaningful and measurable impact, these efforts must become standard, consistently applied, and reinforced through clear accountability across the research ecosystem.

, PhD, is a clinical research recruitment and inclusion executive and strategist. In her most recent role, Johnson led the clinical trial recruitment and diversity, equity, and inclusion functions at SPARC. Prior to that, she held several leadership positions within IQVIA’s patient recruitment team, including advising pharmaceutical sponsor teams with their efforts to achieve more diverse trial populations. Johnson has a Master’s in Public Health and a PhD in Health Sciences. Her doctoral dissertation research focused on increasing access to clinical trials for historically underrepresented populations.

The evolution of US FDA diversity requirements in clinical research. 

https://globalforum.diaglobal.org/issue/december-2023/the-evolution-of-us-fda-diversity-requirements-in-clinical-research-2/

2. Coakley, M., Fadiran, E., Parrish, L., Griffith, R., Weiss, E., & Carter, C. (2012). Dialogues on diversifying clinical trials: Successful strategies for engaging women and minorities in clinical trials. 

3. The Editors. (2021, September 13). Striving for diversity in research studies. 

4. United States Department of Health and Human Services (USHHS), Food and Drug Administration (2025, March 21). 

FDA-led patient focused drug development (PFDD) public meetings

https://www.fda.gov/industry/prescription-drug-user-fee-amendments/fda-led-patient-focused-drug-development-pfdd-public-meetings

5. United States Department of Health and Human Services (USHHS), Food and Drug Administration (2025, March 21). 

FDA patient-focused drug development guidance series for enhancing the incorporation of the patient’s voice in medical product development and regulatory decision making

https://www.fda.gov/drugs/development-approval-process-drugs/fda-patient-focused-drug-development-guidance-series-enhancing-incorporation-patients-voice-medical

6. Food and Drug Administration Safety and Innovation Act, Public Law No 112-144, S. 3187, 21 U.S.C. 301 

Patient centricity in the biopharmaceutical industry: Are we nearly there yet? A collection of perspectives from researchers, approvers, and patients. 

8. Bristol Myers Squibb. (2024, August 1). 

Diversity in clinical trials is a scientific imperative

https://www.bms.com/media/media-library/scientific-media-resources/importance-of-clinical-trials-and-role-of-diversity.html

Medicaid coverage of “routine costs” for clinical trials

https://www.appliedclinicaltrialsonline.com/view/medicaid-coverage-of-routine-costs-for-clinical-trials

https://www.govtrack.us/congress/bills/116/s4742/text

11. Equitable Breakthroughs in Medicine Development (EQBMED). (2024, September 12). 

Equitable breakthroughs in medicine development (EQBMED) to work with inaugural sponsor companies to drive greater diversity in clinical trials

https://www.prnewswire.com/news-releases/equitable-breakthroughs-in-medicine-development-eqbmed-to-work-with-inaugural-sponsor-companies-to-drive-greater-diversity-in-clinical-trials-302246462.html

Anti-‘woke’ backlash forces health industry to adapt DEI efforts. 

https://www.modernhealthcare.com/hospital-systems/healthcare-dei-anti-woke-law-ron-desantis-trinity-health

CommonSpirit to expand DEI programs despite federal pushback. 

https://www.modernhealthcare.com/providers/commonspirit-dei-program-extensions-morehouse

14. The MRCT Center of Brigham and Women’s Hospital and Harvard. (2024). 

The MRCT Center of Brigham and Women’s Hospital and Harvard.

https://dev.mrctcenter.org/project/representation-in-research/

15. Food and Drug Administration. (2024, June). Diversity Action Plans to improve enrollment of participants from underrepresented populations in clinical studies: Guidance for industry. 

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-action-plans-improve-enrollment-participants-underrepresented-populations-clinical-studies

16. National Academies of Sciences, Engineering, and Medicine. (2024).

 Toward a framework to improve diversity and inclusion in clinical trials: Proceedings of a workshop (2024)

. Washington, DC: The National Academies Press. 

17. National Academies of Sciences, Engineering, and Medicine. (2022).

 Improving representation in clinical trials and research: Building research equity for women and underrepresented groups

18. Getz, K., Smith, Z., & Peña, Y. (2020). Quantifying patient subpopulation disparities in new drugs and biologics approved between 2007 and 2017. 

Therapeutic Innovation & Regulatory Science, 54

19. Smith, Z., Botto, E., Johnson, O., Rudo, T., & Getz, K. (2024). New benchmarks on demographic disparities in pivotal trials supporting FDA-approved drugs and biologics. 

Therapeutic Innovation & Regulatory Science, 58

20. Peroutka, S. (2024). Demographic comparison of subjects in FDA-approval trials in the United States to disorder specific demographics using Real World Data. 

Contemporary Clinical Trials Communications, 

21. Reid, M., Davis, S., Henry, O., Mathew, A., McCallister, S., Nero, T., Rabheru, S., Sampson, S., Vanderslice, T., & Williams, D. (2023). Demographic diversity of US-based participants in GSK-sponsored interventional clinical trials. 

22. Exec. Order No. 14173, 3 C.F.R. 8633-8636 (2025). 

https://www.govinfo.gov/content/pkg/FR-2025-01-31/pdf/2025-02097.pdf

23. Exec. Order No. 14151, 3 C.F.R. 8339-8341 (2025). 

https://www.govinfo.gov/content/pkg/FR-2025-01-29/pdf/2025-01953.pdf

24. Exec. Order No. 14168, 3 C.F.R. 8615-8618 (2025). 

https://www.govinfo.gov/content/pkg/FR-2025-01-30/pdf/2025-02090.pdf

25. Seminera, M. (2025, March 8). Universities are facing big cuts to research funding. At Duke, it’s a time for ‘damage control’

https://apnews.com/article/trump-cuts-research-funding-nih-duke-7f24b33bbad54490583520536ab40e0c

26. Constantino, A. (2025, April 30). RFK Jr. is gutting minority health offices across HHS that are key to reducing health disparities

https://www.cnbc.com/2025/04/30/rfk-jr-hhs-job-cuts-minority-health-offices.html

27. Whitlock, J. (2025, May 1). US drugmakers increasingly look abroad for clinical trials as confidence in FDA wavers

https://endpts.com/us-drugmakers-seek-clinical-trials-abroad-as-confidence-in-fda-wavers/

28. Fick, M. (2025, May 14). Upheaval at FDA pushes some biotech firms to move early trials out of US

https://www.reuters.com/sustainability/boards-policy-regulation/fda-upheaval-pushes-some-biotech-firms-plan-early-trials-out-us-2025-05-14/

The inflation reduction act and Medicare drug price “negotiation

https://phrma.org/policy-issues/government-price-setting/inflation-reduction-act

30. United States Department of Health and Human Services (USHHS), National Institutes of Health. (2024, October 21). 

NIH policies and guidelines on the inclusion of women and minorities as subjects in clinical research. 

https://grants.nih.gov/policy-and-compliance/policy-topics/inclusion/women-and-minorities/guideline

31. Durant, R., Davis, R., George, D., Williams, I., Blumenthal, C., & Corbie-Smith, G. (2007). Participation in research studies: Factors associated with failing to meet minority recruitment goals. 

32. Boden-Albala, B., Carman, H., Southwick, L., Parikh, N., Roberts, E., Waddy, S., & Edwards, D. (2015). Examining barriers and practices to recruitment and retention in stroke clinical trials. 

33. Choradia, N., Karzai, F., Nipp, R., Naqash, A., Gulley, J., & Floudas, C. (2024). Increasing diversity in clinical trials: Demographic trends at the National Cancer Institute, 2005-2020. 

Journal of the National Cancer Institute, 116

34. United States Department of Health and Human Services (USHHS), National Institutes of Health, Office of Extramural Research. (2018, January). 

(Funding opportunity announcementRFA-AG-19-001)

https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-19-001.html

Advancing more inclusive and representative clinical trials through action and accountability.

Valdo Arnera, MD

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