Clinical research relies on the volunteer participation of qualified patients to understand the safety and efficacy of novel treatments. Therefore, the recruitment of eligible participants is vital. Unfortunately, recruitment challenges have persisted for decades, especially in underrepresented groups. Enhancing diversity in Clinical research can expand the safety and efficacy profile of new therapies, ensuring sponsors release a diversely effective product.

In the therapeutic area of oncology, particularly Ovarian Cancer trials, recruitment poses numerous challenges that can significantly impact the advancement of medical research. This article explores the intricacies of recruiting for ovarian cancer trials, highlighting the hurdles faced by researchers, clinical research organizations, and patients alike.

Recruitment Hurdles in Ovarian Cancer Trials

Various therapeutic areas suffer from similar patient recruitment challenges. Recruitment remains one of the top factors in a clinical trial’s failure or success. However, for certain therapeutic areas and specific indications, those challenges are magnified. This is the case for ovarian cancer clinical trials.

Difficulty with recruiting diverse women

One of the reasons for this is that ovarian cancer trials require diverse women to participate, which can arguably be one of the most difficult populations to recruit. One study showed that women who responded to an inquiry regarding an ovarian cancer trial noted that “inconvenience” was the most commonly reported reason to opt out of participating in the study. This was especially prevalent in patients who identified as rural residents.

Women are considered underrepresented in clinical research for many other reasons, as well. Since women are oftentimes responsible for childcare, another reason for the lack of participation is in finding adequate childcare during required site visits or trial-specific procedures. In recent decades, as women have more boldly entered the workforce, another reason for the underrepresentation lies in balancing their careers. Women, in particular, struggle to balance their work and family responsibilities, so adding the demands of a clinical trial on top of that can be burdensome.

Compounding diversity also has an effect on participation in clinical trials. While separately, women and people of color make up a small percentage of clinical trial participants, ethnically diverse women are significantly underrepresented. In ovarian trials where there is already restriction on gender, ensuring ethnically diverse women are accounted for can be difficult.

Similarly, elderly women are also less likely to participate in an ovarian cancer clinical trial. While there are many reasons for disinterest in participation, some include a lack of education, mistrust in the staff, and the potential hassle that additional clinic visits might cause. However, not all age-related misrepresentation is due to the patient, but instead is caused by the eligibility criteria.

Stringent eligibility criteria

Clinical trials often come with strict eligibility criteria designed to ensure the safety and efficacy of the interventions being tested. While these criteria are necessary, they can also exclude a significant portion of patients with ovarian cancer, particularly those with comorbidities or late-stage disease.

Oftentimes, there are age limits on study participants that automatically exclude the elderly. Elderly patients can have more complex medical histories and, therefore, can be less likely to qualify for enrollment into a clinical trial. This challenge emphasizes the need to strike a balance between scientific rigor and inclusivity.

Limited patient awareness

Awareness about clinical trials among ovarian cancer patients is notably limited. Many patients and their families may not even be aware that trials are an option, or they might harbor misconceptions about trial participation. This lack of awareness stems from inadequate patient education and communication within the healthcare system.

Physicians play a pivotal role in trial recruitment by identifying potential participants and referring them to trials. However, some oncologists may hold reservations about referring patients to a trial due to concerns about experimental treatments or logistical challenges. Many physicians won’t offer clinical trial information to cancer patients until standard treatment methods have failed.

Guidance from the FDA on Recruitment for Clinical Trials

The FDA has recently provided guidance on the development of a diversity plan to ensure that sponsors are taking a proactive approach to recruitment. Specifically, the FDA stresses the importance of collecting data on race, ethnicity, and/or gender, which is critical to identifying population-specific safety and efficacy signals. The Revitalization Act of 1993 was drafted to ensure that women and minorities were included as participants in clinical trials. Further, the guidelines mandated that clinical trials were designed to elicit information across racially diverse and ethnic subgroups.

Understanding diverse populations

Regulatory officials recommend taking a realistic approach to understand how many individuals from diverse populations can feasibly be enrolled, given the diversity of the geographical areas of each site. By including the number of subjects initially planned for and actually enrolled that belong to underrepresented populations in annual reports, sponsors can proactively correct any ethnic or gender misrepresentation before the conclusion of a study.

Patient-centric study design

Similarly, sponsors can design patient-centric studies by considering the patients’ needs. Offer financial reimbursements for incurred expenses, provide language access to participants with limited English language proficiency, and partner with community-based organizations to provide support for trial participants.

In order to include all demographics in a clinical study, access to the institution must be feasible. This requires additional considerations such as extended office hours to accommodate patients who have restrictive schedules, childcare onsite for mothers and caregivers, and travel arrangements or stipends for participants who must travel a longer distance.

Good Clinical Practice (GCP)

Another consideration lies in the trustworthiness of the clinical staff. Due to the unethical experiments performed in the history of clinical research, patients may be skeptical of the ethical nature of a study when initially approached. However, Good Clinical Practice (GCP) guidelines provide an ethical and scientific framework for the design, conduct, monitoring, and reporting of clinical trials. GCP aims to ensure that the rights, safety, and well-being of trial participants are protected, while also generating reliable and credible data.

By offering comprehensive guidance and education, practitioners can address patients’ doubts, making them feel more at ease about participating in trials. This trust-building process is essential in dismantling the skepticism that historical injustices have sown and encouraging patients to consider the potential benefits of clinical trial participation.

Further Advances in Patient Recruitment

While these guidelines are helpful, there is still a significant challenge in ensuring that a sufficient number of racially, ethnically, and elderly diverse women are enrolled in ovarian cancer clinical trials. Therefore, sponsors oftentimes elicit the help of experienced clinical research organizations (CROs) to assist with recruitment.

The Vial CRO is committed to implementing a tech-enabled patient recruiting strategy. Vial has tested over 30 marketing channels across clinical trials to determine the best methods. They have found that social media advertisements, direct mail flyers, radio commercials, and even phone call inquiries are some of the best ways to announce the need for patients to participate in a trial.

Similarly, Vial uses EMR filtering software to find patients who qualify for a study already established at a particular institution. By inputting study criteria, the software can filter through the EMR and find patients with specific laboratory values, diagnoses, and previous treatments.

Overcoming the Challenges of Recruiting for Ovarian Cancer Trials

Patient recruitment for gender-defined therapeutic areas, such as ovarian cancer, can be limiting, especially in regard to ethnically, racially, and elderly diverse women. While there are many reasons that patients may be apprehensive about agreeing to participate in a clinical trial, the FDA gives strategic guidance on ensuring that all demographics are represented.

Overcoming the challenges of recruiting for ovarian cancer trials necessitates a multi-faceted approach involving researchers, healthcare providers, patient advocacy groups, and innovative technologies. As medical advancements accelerate, collaboration and innovation become increasingly vital. Sponsors can partner with experienced Oncology CROs to enhance their recruitment efforts and provide more comprehensive efficacy and safety data for impactful new therapies.

At Vial, we understand the critical nature of clinical trial recruitment, especially in complex areas like ovarian cancer research. Our Oncology CRO services are tailored to address these recruitment challenges head-on. With years of experience, a deep understanding of oncology, and a technology-forward approach, we have the right strategies to help oncology sponsors run faster, better, and more affordable clinical trials.

Ready to run more affordable oncology clinical trials? Contact a Vial team member today!