Addressing Ophthalmics Sponsors’ Most Pressing Challenges w/ Nicole Derthick

Nicole Derthick is Sr. Vice President of Clinical Operations and Delivery. She has been with us for over 4 years and has had a role in most of our clinical studies, accruing invaluable customer insights. Check out her learnings and advice for optimizing your ophthalmic studies.

In your experience speaking with ophthalmology clients, what do you think matters most to them for their studies?

The consistent message we hear time and again from the CEOs we speak with is that they care most about ensuring that their CRO partner helps them meet their study timelines. So that’s also our priority here at Lexitas, to help our clients deliver a new drug to market, both on time and within budget.

This really shouldn’t be a surprise. Industry-wide, 80% of all studies are delayed at least one month, costing sponsors significant money and resources. This is a broken status quo. Doing a better job of meeting study timelines is an area ripe for opportunity for CROs. And that’s particularly true in ophthalmology, given that it is such a unique subspecialty.

And because we are in a niche, I think it’s important to recognize that not every CRO is the same. There are some that are purely focused on a specific therapeutic area. Their employees are focused, passionate, and knowledgeable. It’s a combination that really has a lot of tangible benefits.

How does that translate to what your team is doing in clinical operations?

Focus, passion and knowledge is what we prioritize here at Lexitas. It all starts with our culture and values. We are selective about whom we hire. People have to have experience in ophthalmology and/or clinical trial operations. We’re 100% intentional about hiring people with this specific expertise.

Because we hire with purpose, our team members care about the industry and the patient, and they care about how they show up for clients. And we avoid hiring individuals who put “I” over “Us”. Collaboration is just one of the key values here at Lexitas. We live by that.

In what way does this impact clients?

We have strong cohesive teams in our delivery and operations groups. This has a huge, positive impact on our projects, and we hear that feedback from clients a lot.

For example, our company size provides a level of consistency throughout the delivery. New hires are trained into ‘the Lexitas way’ by the existing team and benefit from all that expertise that’s been accumulated over the years.

Our employee’s longevity also helps us get to know the client really well. We know what they prefer, we know how to handle those accounts. It leads to better client management and how we complete tasks for them. Our Project Managers and Directors meet regularly with each other so they can talk freely and share ideas for addressing issues. They get to know each other quite well also, and it increases collaboration.

And sponsors also benefit from our ophthalmology expertise because we are so close to the client. If they have questions about ophthalmology or operational questions about biostatistics, data analysis, or something like that, we provide direct help. They can get answers and solutions right away, and that’s something you will never get at generalist CROs. We are very collaborative in that sense. It’s easier to access our expertise.

All that put together leads to a better product for our clients.

And this probably translates to site relationships as well, right?

Absolutely. Our CRAs know the sites very well. They know what each site is capable of, and where they need help. It all leads to better management on our end.

Our coordinators have been working with specific sites for so long, they know everyone very well. It develops a level of trust and sites will sometimes prioritize our studies because of our relationships.

Have you seen a change in the site-sponsor relationship over the years?

We have. Before COVID, sponsors had all the leverage. But now the tables have turned. When sponsors are difficult to work with, it’s much harder to enroll those studies. The sites don’t want to work with them and end up giving preference to other sponsors. Basically, the power has shifted to sites.

So it really helps us that sites in our network trust our monitors and coordinators. In niche therapeutic areas like ophthalmology, sites can be picky about which studies they want to work on. But they’ll happily work with us because of those long-established relationships we’ve developed with them. A mega-CRO with loose or non-existent relationships with ophthalmology sites simply cannot deliver the same level of service.

So what should these companies look for when evaluating CROs?

In the ophthalmology space specifically, I think that sponsors really need to think hard about who they partner with. Should you work with a large CRO because they have expertise in all therapeutic areas, or are you better off working with a product development organization that has specific ophthalmics expertise? More often than not, I’d say it’s the latter. The focused product development organizations offer a deeper partnership by taking greater responsibility for the success of both the study and the drug.

What specific advice do you have for sponsors who are thinking about starting a clinical trial?

Enrollment has been a challenge for most protocols across therapeutic areas over the last few years. Therefore, it’s critical that you design your trial with the patients in mind. They need simple, they need convenient, and the benefits should outweigh the risk. It’s just a reality that efficient and pragmatic trials enroll faster. The data is cleaner and easier to reconcile and analyze. By reducing the burden on the patients, you’re also reducing your costs and time to complete the trial.

Actually, a couple of our clinical leads, Ashley and Rebecca, gave some wonderful and actionable advice on how to overcome the enrollment challenge in ophthalmology. Take a look.

Thank you Nicole!

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