Decentralized Clinical Trials May Address Gender Bias, Inclusivity of Clinical Trials

Gender gaps, with consistent underrepresentation of females, present a substantial challenge in clinical research.¹ Achieving a balanced representation of both genders has proven exceedingly difficult, necessitating solutions to address this pervasive issue. Decentralized clinical trials (DCTs) are emerging as a crucial avenue for transforming this gender bias and fostering inclusivity within health care research.

Attaining quality and effectiveness of clinical trials depends on eliminating gender bias and ensuring that female representation is encouraged. This article delves into the complexities of gender disparity in clinical trials, as well as highlights the importance of DCTs and its transformative role in fostering inclusivity, eliminating gender bias, and promoting patient-centric research methodologies.

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Looking Into the Complexities of Gender Disparity

To devise effective solutions, it is imperative to understand the multifaceted factors that contribute to gender disparity. These factors encompass social, biological, and systemic barriers that collectively impact female participation in clinical trials.

Social Barriers: A Link to Socioeconomic Status

An in-depth analysis reveals that low socioeconomic status is a major contributor to gender bias.² This prevents women from taking part in clinical trials and creates geographical barriers, thus hindering their engagement in both remote and traditional studies.

Biological Constraints: Addressing Health Inequalities

In regions with poor health care access, women often face malnutrition. Further, there is a lack of awareness about clinical research in these regions. These factors, coupled with stringent eligibility criteria, further limit women’s participation in clinical trials.

Systemic Challenges: Bridging the Understanding Gap

The complexities inherent in clinical trials are not always comprehensible to research participants. A detailed explanation of the procedure is not always given to the patients. This gap between participant expectations and trial requirements contributes to concerns, fears, and doubts, leading to higher attrition rates.

Historical Bias and Gender-Specific Health Concerns

There is a persistent historical bias toward male participants in clinical research. This bias, in addition to inadequate recruitment strategies that favor men, continues to discourage female participation. Further, gender-specific health concerns often take a backseat in the funding of clinical research due to the underrepresentation of women in decision-making roles for such funding. As a result, targeted approaches addressing women’s health and their health concerns are often unaddressed.

The Plan of Action: Empowering Clinical Research Through DCTs

The transformative role of DCTs in overcoming gender bias becomes evident with their accessible and patient-centric methodologies. These methodologies are designed to be user-friendly and can even be used with geographical barriers. They play a crucial role in encouraging women to participate, thereby narrowing the gender disparity gap.

The transformative role of DCTs in overcoming gender bias becomes evident with their accessible and patient-centric methodologies.

Integrating Telemedicine: A Crucial Step

To harness the full potential of clinical trials, integrating telemedicine into the trial process is crucial. This integration, supported by digital health technologies such as virtual engagement tools, e-consent, and digital platforms enhance participation rates and fosters a more inclusive environment for women to engage in clinical research.

DCTs also eliminate the need for physical travel, significantly reducing travel expenses.³ This shift makes participation less tiring, less time-consuming, and less complicated, fostering a more inclusive and accessible environment for research participants.⁴

Ensuring Data Security and Inclusivity

DCTs foster a culture of transparency and engagement while ensuring the security of patient data. Thorough scrutiny of these trials ensures the secure storage of that data, retaining patient trust through the encryption of exclusive patient information.

Benefits of Inclusivity in DCTs

The incorporation of digital health technologies into DCTs brings forth myriad benefits. This is seen particularly in the realm of inclusivity. By seamlessly integrating digital health, DCTs transcend traditional limitations and offer real-time data collection capabilities that revolutionize the entire research landscape. This technological synergy not only simplifies the analysis process but also furnishes researchers with comprehensive insights into the intricacies of women's health.

One of the primary advantages of this integration is the facilitation of a targeted and precise approach to health care intervention. It is possible to tailor interventions according to the unique health care needs of women with the real-time data collected through digital health tools. This personalized approach contributes to the development and identification of gender-specific biomarkers specifically designed to cater to women's health.

Furthermore, the continuous and instantaneous nature of data collection in DCTs, made possible by digital health integration, allows for a dynamic understanding of women's health during the trial. This perspective enhances the overall effectiveness of health care interventions and ensures responsive to evolving health patterns and individual participant experiences.

In essence, the benefits of inclusivity in DCTs, facilitated by the integration of digital health, extend beyond the conventional boundaries of clinical research. They pave the way for a more nuanced, personalized, and responsive approach to women's health, ultimately contributing to the advancement of gender-specific health care practices and the discovery of innovative solutions tailored to the diverse needs of female participants in clinical trials.

The Key to Successful Clinical Trials: Embracing Diversity for Effective Research

A diverse participant pool contributes to a more comprehensive understanding of diseases, promoting better research outcomes. Remote tools available with DCTs facilitate active participant engagement, providing automated reminders to enhance study adherence. These methods can be used to keep participants actively engaged in a trial, especially by providing automated reminders when study tasks are due.⁵

Considerations for Stakeholders Adopting DCTs: What’s in The Store?

In the context of the growing interest from stakeholders, sponsors, and investigators in embracing DCTs, it becomes essential to meticulously ensure regulatory compliance and robust data security measures. The fundamental requirement is in keeping up with the ethical standards, particularly in guaranteeing the utmost privacy of patient data. This commitment not only fosters transparency in the realm of clinical research but also plays a pivotal role in retaining the trust of participants.

Establishing transparent communication protocols between stakeholders and patients is needed to highlight the ethical practices within the intricate landscape of drug development. Additionally, actively engaging research organizations and stakeholders is essential in crafting a comprehensive framework for the seamless implementation of DCTs.

A collaborative impact creates an environment that prioritizes the collective advancement of health care research and aligns with ethical principles. This ensures a responsible and trustworthy foundation for the evolving landscape of DCTs.

Transformative Steps Towards Targeted Health Care

DCTs have emerged as a pivotal force in rectifying the historical gender disparity prevalent in clinical research. This actively promotes the inclusion of women and fosters a culture of inclusivity.

In the health care research arena, DCTs stand as transformative agents. They profoundly influence the landscape by addressing and mitigating gender-specific concerns. This massive shift not only propels drug discovery endeavors but also contributes significantly to shaping present-day health care initiatives.

Ultimately, the adoption of DCTs signifies a step in the direction of targeted health care for women. By actively engaging in patient-centric practices and adhering to regulatory frameworks, stakeholders not only bridge gender gaps but also contribute to the alignment of global health care initiatives with sustainable development goals. In essence, DCTs herald a new era where health care research is characterized by inclusivity, responsiveness to diverse needs, and a commitment to advancing the health and wellbeing of women, thereby bridging the gender gap.

About the Author

Harsha Rajasimha, PhD, MS, is the founder and CEO of Jeeva Clinical Trials Inc, based in Virginia. The personal experience of losing a child born with a rare congenital disorder and a brother with a chronic disease became the springboard for Rajasimha to apply his years of postdoctoral research experience at the NIH and FDA to accelerate therapies for rare and common conditions. He founded Jeeva with the mission of lowering the cost of drug development and accelerating the speed of clinical trials by purpose-building a modern technology platform that empowers sponsors to run clinical trials, with fewer fragmented systems, fewer employees, with significantly less burden on clinical researchers and patients, which has allowed for a more globally diverse population to access clinical trials remotely.

Today the Jeeva eClinical Trial platform supports sponsors and CROs across the globe helping reduce the logistical burdens on patients and study teams by over 70%. Its complete suite of technology supports fully decentralized and hybrid clinical trials and has resulted in being selected by research hospitals, CROs, and sponsors developing pioneering therapeutics such as Frantz Viral Therapeutics and ImmunoACT. The Virginia-based company's modular cloud-resident software-as-a-service is highly scalable and facilitates patient enrollment, engagement, and evidence generation in clinical trials from one login from any browser-enabled mobile device. Visit https://jeevatrials.com/.

References

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2. Sharrocks K, Spicer J, Camidge DR, Papa S. The impact of socioeconomic status on access to cancer clinical trials. Br J Cancer. 2014;111(9):1684-1687. doi:10.1038/bjc.2014.108
3. Dorsey ER, Kluger B, Lipset CH. The New Normal in Clinical Trials: Decentralized Studies. Ann Neurol. 2020;88(5):863-866. doi:10.1002/ana.25892
4. Banks MA. Core Concept: In the wake of COVID-19, decentralized clinical trials move to center stage. Proc Natl Acad Sci U S A. 2021;118(47):e2119097118. doi:10.1073/pnas.2119097118
5. Hanley DF Jr, Bernard GR, Wilkins CH, et al. Decentralized clinical trials in the trial innovation network: Value, strategies, and lessons learned. J Clin Transl Sci. 2023;7(1):e170. doi:10.1017/cts.2023.597

[This article was originally published by our sister publication, Pharmacy Times.]