3 Strategies For Diverse, Large-Scale Clinical Studies
By Chuanbo Xu, senior director, clinical development, Freenome
According to the American Cancer Society, colorectal cancer (CRC) is the second-most common cause of cancer deaths in the United States.1 What people may not know is that CRC can be treated and even prevented when detected early. That’s why getting screened is so critical. And yet, one in three people eligible for screening haven’t been screened.2
For some, taking a few days off work for a colonoscopy is inconvenient or unrealistic. For others, the bowel preparation or stool experience can be off-putting. To improve adherence and reduce these kinds of barriers, Freenome is developing a test that’s convenient, less cumbersome, and easy to administer with a standard blood draw at a doctor’s office or health clinic. If we want to bring our test to everyone, we needed to design a robust study that would inform how to best expand screening access to patient populations.
When we began designing this study in 2019, we thought long and hard about our patients and who they were, where they lived, and their available resources. Our patients had varying levels of knowledge and understandable fears about clinical trials. They ranged in age, race, ethnic background, and socioeconomic status, including those without health insurance.
The population of clinical studies remains mostly White. However, research shows racial and ethnic minorities are generally willing to participate in clinical trials at levels comparable to that of Whites3 but frequently lack easy access to participate.4 We had to think differently to reach a broader population and to change that statistic. Anyone, in any ZIP code, should be able to participate in clinical trials.
By working through a few challenges that many other companies have surely faced in clinical trial development, we were able to maintain our anticipated launch timeline, training standards, and goal of recruiting a diverse pool of patients that ultimately led to a successful trial launch. Information learned from the design process revealed insights that will not only positively impact our design process in the future but may also provide helpful insights to others.
1. Build Relationships With National And Local Partners To Better Understand Patient Communities And Their Needs
Traditional teaching hospitals are great study partners, but we need more. We need to enlist credible partners on the ground to reassure patients and provide education on CRC screening and clinical trials. Our clinical development teams need training in working with sites with limited resources or no experience supporting clinical trials.
For us, partnerships with organizations like Colorectal Cancer Alliance (CCA), Intercultural Center for Health Research, Día de la Mujer, Morehouse School of Medicine, and CVS Health’s Clinical Trial Services were crucial to understanding different patient populations and extending our reach. Clinical trial designers should think strategically about which local and national organizations may help them reach more patients.
Going out and building these relationships takes time and should not be forced. It’s important to think of them like any other relationship and prioritize trust and transparency. Trust that your partner is bringing their unique expertise to help the group reach the shared goal. Ensure transparency on strengths and weakness to divide and conquer. Throughout the trial development process, we kept an open dialogue with our partner organizations, creating a true team environment where they were able to utilize their strengths to help equip our team with the resources and education to conduct community outreach.
2. Provide Flexible Participation Options
When we launched PREEMPT CRC in spring of 2020, we had multiple avenues and options for people to participate:
- Brick-and-mortar study sites: With more than 200 study sites, including health systems, teaching hospitals, community hospitals, and tertiary clinics across the country, we ensured patients had options for in-person participation.
- PREEMPT CRC website: A dedicated website was developed offering information and the option to ask questions and register for PREEMPT CRC.
- Electronic consenting and virtual enrollment: Working with our physician investigators, we offered electronic consenting to make it more convenient for patients to consent and enroll in the study online.
- Mobile phlebotomy: For those patients who were not close to a hospital or other brick-and-mortar study sites, we provided mobile phlebotomy teams to conduct blood draws at patients’ homes.
- 24/7 patient support: Phone calls and email communication from the study staff provided patients with additional support and information to navigate the study process.
By offering a variety of in-person and virtual ways for participants to learn about the study and communicate with providers, patients felt supported throughout the study. Flexible options not only allow studies to reach more participants but can also build trust between researchers and their patients.
It’s important to note that offering multiple options for participation may take a toll on a company’s internal team and resources. By removing silos to create a true team environment, we were able to increase bandwidth and leverage our partners to ensure flexibility for our patients. Because we made sure to reinforce our shared goal of a patient-focused strategy, team members were more motivated to put in the additional effort to ensure the site and virtual participation options were available in a timely manner.
3. Hire Culturally Competent Staff To Tailor Communication To Diverse Populations
A strategic clinical trial design should also consider who communicates with patients day-to-day. A culturally competent staff understands the diverse communities they are working with. What works for one community may not work for another. By tailoring communications and materials to the population’s language and culture, we built trust and empowered providers to better address patients’ unique needs and fears.
We took the time to meet with our potential new hires and considered how best to leverage their unique insights and experiences. This helped us hire a culturally representative staff. Finding the right personnel requires reevaluating your hiring process. Consider these questions throughout the interview process: Are you hiring like-minded people who share your goals? Will these new hires understand the patient community in which you are looking to recruit?
What were considered creative and innovative recruitment practices in 2019 must now become the norm for all researchers. While we did not plan for a global pandemic, offering remote options allowed us to maintain a steady cadence of enrollment in 2020 through 2022.
When we closed enrollment earlier this year, we had more than 35,000 completed participants. Early data suggests that 11.3% of our participants are Black and 10.3% are Hispanic. Typically, Black and Hispanic people represent only 5% and 1% of clinical trial participants, respectively.5
Conducting a clinical study during COVID-19 was challenging, but the takeaways were incredible and can be applied across any diagnostic or therapeutic area. By getting into the mindset of patients, researchers can offer a variety of options for education and participation:
- Community partners extend reach and offer trust and credibility to educate patients on the clinical study process and their role.
- Virtual recruitment, electronic consent, and mobile phlebotomy create options to reach patients outside of urban areas with teaching hospitals.
- Culturally competent staff tailor communication to specific populations.
As clinical studies evolve in this new normal, a patient-first mindset will continue to be instrumental in all aspects of study design. A diverse study takes time and effort, but as our results show, it’s worth it.
- https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and- figures/colorectal-cancer-facts-and-figures-2020-2022.pdf
- Durant, R. W., Legedza, A. T., Marcantonio, E. R., Freeman, M. B., & Landon, B. E. (2011). J. Cult. Divers., 18(1). 8-19
- doi: 10.1200/EDBK_100021 American Society of Clinical Oncology Educational Book 39 (May 17, 2019) 3-10.
- The Society for Women's Health Research United States Food and Drug Administration Office of Women's Health. Dialogues on diversifying clinical trials; 2011.
About The Author:
Chuanbo Xu, Ph.D., leads clinical development at Freenome. His department is responsible for the design and implementation of product development clinical studies, including the more than 35,000-subject PREEMPT CRC trial. Prior to Freenome, Xu held leadership roles at GRAIL, Wako, Abbott, Genaissance Pharmaceuticals, and GSK. Throughout his career, he has led and participated in product development across multiple disease areas, including oncology, cardiovascular, and infectious diseases. He holds a Ph.D. in immunology.