By Sabrina Johnson, CEO, Daré Bioscience
When the WHO declared COVID-19 a pandemic, the world shut down. It was an unforgettable time in history: countries sealing borders, businesses closing, and governments issuing stay-at-home orders. Biotech and pharmaceutical companies around the globe fought to keep their clinical trials on track. But with altered clinic procedures, packed hospitals, masking, social distancing, and constantly evolving guidelines, we all felt the impact across clinical site engagement, study design, and patient enrollment. Effectively engaging with a CRO assisting with study execution had never been more important than in that moment — and during the two years that have passed since the WHO’s initial declaration of the pandemic.
At Daré Bioscience, we experienced the various challenges the pandemic caused for companies conducting clinical trials firsthand as we were set to begin a Phase 3 multicenter study for bacterial vaginosis (BV), the most common vaginal condition affecting women of reproductive age, just as the pandemic hit. With so much uncertainty related to potential shutdowns, we did not want to delay our study start. BV is a significant health issue facing women, and the approved treatment options at the time had relatively insufficient clinical cure rates or could be inconvenient for women to use. We wanted to move quickly to reimagine our trial design and recruitment strategy to ensure success during such an uncertain time, including how best to engage with our CRO.
Building a collaborative and highly engaged partnership with a CRO to optimize study enrollment is critical for a company’s success, particularly with so much reliance on virtual interactions. Here are some tips on how to do just that.
Choosing The Right CRO
Selecting the right CRO can be a daunting and arduous process. Here are some criteria to keep in mind when selecting the ideal CRO partner for your organization.
One key consideration is experience and service. It is important to assess the company and staff’s overall experience, but most importantly, their expertise in your therapeutic area. Ask questions about their track record and the results they have delivered. Find out if they have worked on clinical trials at all stages of development and if they have experience working in the disease indication for which you are developing a treatment. Determining the scope of services that a CRO can provide is equally important. If your company is conducting multiple studies, a CRO with a broad range of services in multiple therapeutic areas may be a good fit. On the other hand, if your trial requires niche expertise, you may be better off with a specialized CRO with experience in fewer therapeutic areas.
For example, with our BV study, we chose to partner with Health Decisions, a Division of Premier Research. Health Decisions is a full-service CRO specializing in all areas of women’s health and diagnostics clinical research. Fortunately, we had successfully worked with Health Decisions on prior clinical studies, so we knew their expertise in clinical development of women’s health products, existing network of clinical sites, and relationships with KOLs and investigators would help accelerate clinical development in an efficient manner. However, when we initially engaged with the company, we asked these questions during our vetting process to ensure their expertise aligned with the specific nuances of not only conducting research in women’s health, but more specifically, the intricate nuances of our product candidate and the indication we would be pursuing.
It is also important to make sure it is a good cultural fit. When you interview a potential candidate for a position at your company, you ask yourself, “Will this person’s beliefs and behaviors align with our core values and company culture?” The same principle applies when hiring another company to work with you on conducting a clinical trial, which is such a critical component of a drug development program, and ultimately, registration for market authorization. Before combining forces, it is crucial to assess the CRO’s company culture to determine if values, priorities, practices, and management styles would mesh well.
CRO And Study Site Management
Identifying the CRO best suited for your company is the first challenge. The next then becomes managing the CRO relationship and working collaboratively together to remain on track with the trial sites and overall study objectives.
Establishing clear roles and responsibilities for both parties is a simple – yet crucial – first step in managing the CRO relationship. Every company has different needs and unique approaches to conducting a clinical trial, so it is of paramount importance to communicate these as clearly as possible.
I also strongly recommend frequent communication with the CRO. Routine meetings can help foster a strong partnership mentality and help build a cohesive team — one that can work seamlessly together toward your collective objectives. Additionally, with new study protocols required to adhere with COVID guidelines, regularly meeting with the CRO to proactively identify and address issues in real time helps ensure the established timelines and study milestones are met.
At Daré, we met on Zoom regularly with the team at Health Decisions and conducted a “therapeutic training” to reinforce the benefit of study participation, while ensuring that study vendors and our CRO could help sites easily adapt to new guidelines and a virtual environment. Also, our site monitors conducted weekly outreach on therapeutic questions, site queries, data entry, and enrollment trends. This, coupled with our CRO conducting monthly calls with investigators to discuss high-level study updates, including enrollment progress and operations, helped support seamless project execution.
Our CRO also helped our study sites adapt to “new norms,” providing training and support as needed to assist in navigating new challenges. Working hand-in- hand to uncover patient engagement and enrollment strategies proved to be incredibly helpful, and it ensured our study remained not only on track, but ultimately ahead of projections.
"Building a collaborative and highly engaged partnership with a CRO to optimize study enrollment is critical for a company’s success, particularly with so much reliance on virtual interactions."
Growing With Your CRO
As we all know too familiarly, the COVID-19 pandemic fundamentally shifted how our industry conducts clinical trials and our overarching drug development processes. However, I have seen firsthand how establishing a foundational CRO relationship helps eliminate many of these challenges — as well as provide new opportunities for efficiencies.
Daré’s high study engagement during the global pandemic indicates the need for continued virtual and decentralized management options. Enrollment in our bacterial vaginosis trial occurred nearly twice as fast as anticipated, and sites were highly engaged and effective throughout the process. I have no doubt that building a collaborative relationship and working closely with our CRO partner played a critical role in the success of our trial enrollment and, ultimately, the FDA approval of our BV product.
While it is a process that requires an investment of time and effort initially, choosing the right CRO collaborator pays off. I believe that the selection of the right development partner will become increasingly important throughout the drug development process for biotech and pharmaceutical companies of all shapes and sizes — regardless of disease area or therapeutic focus.
About The Author:
Sabrina Johnson is the CEO of Daré Bioscience.