Removing Socioeconomic Barriers and Increasing Diversity in Clinical Trials Would Have a Positive Economic Impact

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Between logistical burdens, distrust in the healthcare system, and lack of awareness and information in many non-English languages, key demographic groups like women, children, low-income households, and racial and ethnic minorities are effectively left out of clinical trials.

Clinical trials have a failure rate of 30% because they cannot meet their target patient enrollment, which is often caused by a lack of diversity in clinical trial candidates. This results in setbacks in 85% of clinical trials causing biopharmaceutical sponsors to lose $600K to $8M for each day a trial is delayed.(1) Limited representation and inclusion of a diverse population in clinical trials have far-reaching consequences by skewing clinical trial results, leading to poorer health outcomes and premature deaths among the U.S. population. Jeeva Informatics is the leading human-centric eClinical platform seeking to accelerate patient recruitment and retention by being champions of diversity, equity, and inclusion in clinical trials through decentralization and reducing socioeconomic barriers to healthcare.

“Recruitment for clinical trials is severely broken,” explains Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics. He notes, “Between logistical burdens, distrust in the healthcare system, and lack of awareness and information in many non-English languages, key demographic groups like women, children, low-income households, and racial and ethnic minorities are effectively left out of clinical trials.” The Future Elderly Model developed by the USC Schaeffer Center found that if drug development using more representative clinical trials eliminated just 1% of these health disparities, it would result in significant gains for patients and society. The study further concluded that increased representation in clinical trials could save billions of dollars and improve the quality of life for millions of Americans.(2)

One out of four patients cites logistical burdens, such as access/cost of childcare, transportation, and loss of pay, as the primary reasons for not taking part in clinical trials. The vast majority of participants are Caucasian adult males from affluent backgrounds.(1) Patients with an annual household income of less than $50,000 have 32% lower odds of trial enrollment. Aside from financial challenges, other socioeconomic obstacles, such as a lack of insurance, limited job flexibility, and health illiteracy, contribute to a generalized apprehension regarding clinical trials.(3)

Regulatory agencies are now taking steps to encourage researchers to make diversity a focus. The FDA recently released its “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” In it, they recommend financial reimbursement or compensation for expenses incurred, language assistance for participants with limited English language proficiency, and clinical trial sponsor enrollment goals for underrepresented racial and ethnic participants.(4)

In addition to saving billions of dollars and improving the health of all American citizens, improving diversity helps build trust between the pharmaceutical industry and the public, which has long been a strained relationship. Biopharmaceutical companies are forming partnerships with local communities and patient advocacy groups, offering financial support, and providing more convenient trial locations to help improve access, spread awareness, and build trust among more diverse populations.(5)

A decentralized trial model helps meet patients where they live and utilizes local community leaders to earn participants’ trust and make them feel more comfortable about the information. For Dr. Rajasimha, diversity has been a priority from day one. While regulatory bodies and researchers tout the benefits of diversity, the reality is harder to achieve and requires more time and resources. The traditional model of all in-person patient visits no longer works, and to achieve operational flexibility with reliable and accurate results, Dr. Rajasimha and his team developed the modular Jeeva™ eClinical Cloud by leveraging stakeholder inputs over the last few years. This human-centric and empathetic platform accelerates clinical research timelines over 3x faster.

With bi-directional communications, activity scheduling, eligibility screening, and remote touchless electronic informed consent, investigators can educate and enroll participants safely from their own mobile devices. Investigator teams can avoid repetitive tasks and save 70% of their time during enrollment. Dr. Rajasimha stresses, “It is imperative that, as an industry, we work to accelerate clinical trials to bring new medicines or vaccines to all patients, including historically underrepresented minorities, who need them, thus increasing the chances of survival. Our modular platform is fully scalable and facilitates diverse patient enrollment, engagement, retention, and evidence generation.”

About Jeeva Informatics

The personal experience of losing a child born with a rare disease and a brother with a chronic disease became the springboard for Dr. Harsha Rajasimha to apply his years of postdoctoral training at NIH and FDA to accelerating therapies for rare and common conditions. He knew that technology in itself is not the limiting factor and that patient-centered design guided by stakeholder needs and regulatory requirements would guide their continuous learning digital platform. By digitizing and automating manual repetitive tasks and reducing the logistical burdens on patients and study teams by over 70%, Jeeva accelerates the process of bringing new medicines or vaccines to patients who need them by over 3x faster. The Virginia-based company’s modular software-as-a-service platform is fully scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials on any browser-enabled mobile device. Visit https://jeevatrials.com/.

References
1. Frank Sasinowski, MPH. “Jeeva – Accelerate Clinical Research, Maximize Patient Diversity.” Decentralized Clinical Research Software as a Service, jeevatrials.com/.
2. Goldman, Dana, et al. “Lack of Diversity in Clinical Trials Costs Billions of Dollars. Incentives Can Spur Innovation.” USC Schaeffer, 30 Sept. 2022, healthpolicy.usc.edu/article/lack-of-diversity-in-clinical-trials-costs-billions-of-dollars-incentives-can-spur-innovation/.
3. Price, Kyla N., et al. “Facilitating Clinical Trials Participation of Low Socioeconomic Status Patients.” Dermatology, Karger Publishers, 15 Dec. 2020, karger.com/Article/FullText/511889.
4. “FDA Guidance on Diversity Plans in Clinical Trials: What You Need to Know.” Bass, Berry & Sims PLC, bassberry.com/news/diversity-plans-clinical-trials/.
5. “Achieving Clinical-Trial Diversity Requires Trust, Awareness, Access.” Deloitte United States, 2.deloitte.com/us/en/blog/health-care-blog/2022/achieving-clinical-trial-diversity-requires-trust-awareness-access.html.

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