Meet the Experts: Roisheen Doherty, Manager, Clinical Trials

Roisheen Doherty has deep experience in research operations, from conducting fitness assessment protocols for firefighters, Olympians, and NHL players, to supporting patients in breast care oncology research, to managing trials for pediatric brain cancer. 

She brings that insight and an ongoing quest for improvement (“What am I seeing and how can I make this better?”) to her work supporting pharmaceutical companies and contract research organizations (CROs), clinical trial sites and physicians interested in finding trials for their patients.  

In this conversation she describes the multi-disciplinary, collaborative efforts she manages, leveraging data to help clients identify trial sites, patient cohorts, and practices with potential participants. 

Share a bit about your background: How did you arrive in this role?
I began my career in human subject research in exercise sciences, as an instructor and in lab operations. This included kinesiology research in sports and workplace scenarios, from designing physical education programs, to work on obesity studies and pediatric exercise plans, to establishing fitness regimes and testing for wildland firefighters and Royal Canadian Mounted Police. Even working with Olympic-level athletes and NHL players on their training programs.

I moved into clinical research as a clinical research coordinator (CRC) in breast care oncology. There I really got an understanding for the importance of the CRC role. Along with the administrative and coordinating tasks, this particular role was very high touch. I worked very closely with the participants; they could contact me for support at any time. I would assist in enrolling and scheduling and often, I’d go to the infusion center with them, and visit them before surgery. 

Then I worked as a clinical trial manager and project manager in pediatric neuro-oncology at University of California San Francisco (UCSF), working hands-on with protocols and regulatory processes, managing trials and CRCs, and supporting the primary investigators in protocol development.

At UCSF I became interested in registries, and product applications for electronic data capture (EDC) and clinical trial management. Verana Health presented a great opportunity to work with data and software and support trials from a different angle.

Are there key insights or lessons from your previous experience that influence your work at Verana?
My philosophy is influenced by my experience in operations: What am I seeing and how can I make it better? Where are the opportunities for improvement? 

Physicians and trial site staff are so busy. The more streamlined we can make processes, the more we can help them access and decipher the data, the better the chances for success.

A key insight from my previous experience relates to the informed consent process, which can take anywhere from a day to six weeks. It’s important to understand that there are people at the end of the data. The real heroes of clinical trials are the CRCs, who work with all the data and build relationships with candidates. 

What are the key issues that clients should consider as they prepare for a clinical trial?

A primary issue for sponsors or CROs is resourcing: When searching for sites – Can a site run the trial? Do they have the equipment and staffing? Then it becomes a matter of setting the trial up for success. 

That’s where we come in. Verana can help find patient cohorts and practices or sites with potential patients so they can meet enrollment requirements more successfully. We can help find sites in the right locations so that patients can actually get there. We use data to look at ways to decrease the access burden for patients, and to decrease the decision-making burden for sponsors.

Patient advocacy is also becoming an important issue. There’s a lot going on in the industry to make it attractive for a patient to participate. Some sponsors are doing a great job of bringing in patient advocates in their disease area.

Are there any issues related to setting up clinical trials that don’t get enough consideration or are often overlooked?

One consideration is the lengthy time required for site feasibility and set up: Finding appropriate sites with the patient cohort and the effort to engage and enlist participants. 

It is common for sponsors and CROs to continually go back to the well. They go back to the same sites they’ve used over and over again. The problem with that is twofold: Those sites may become heavily impacted because other sponsors and CROs are also trying to use them. And they may or may not have the patients you need. 

With access to exclusive registries, we know where the patients are, what conditions they have and we can help determine which ones may be eligible to screen for a particular trial. So sponsors can uncover sites they weren’t aware of instead of spending all their time trying to get a site that may not have the patients.

Could you elaborate on the trial site feasibility process, and how Verana helps sponsors/CROs identify suitable sites?

There’s a huge process involved in choosing a site to run and conduct the trial. It’s very specific to the sponsor’s requirements, the protocol requirements and the disease: Do they have the right experience, equipment, staffing? Can they demonstrate they have the correct patient cohort?

Verana can help by searching the registry data for patient cohorts. For example, with an ophthalmic study, we can look at all of the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) data to find which existing trial sites have the correct patient cohorts are, and also where nearby practices may have potential patients. This can also help with where to focus recruitment efforts.

This helps the CRO or sponsor plan trials, ensure the right geographical coverage. It can reveal potential sites they’ve never worked with and create an opportunity to expand their access to patients and practitioners. If sponsors need help connecting with a trial site that they haven’t worked with before, we can navigate introductions to them. 

What does pre-screening support entail and how does that benefit clients?

For pre-screening support we run the data through an algorithm matched to the protocol to screen out patients that are not eligible. This helps practices focus their attention on who’s a likely candidate. Then they can go through and confirm their likelihood, and if they’re likely, start the patient engagement. Are they interested and willing to do the trial?

What are some of the tools and resources available to clients?

Verana provides simple-to-use tools that apply real-world data to help sponsors and CROs make data-driven decisions. For example, Verana Trial Connect helps trial sites to identify eligible trial patients from their own data. It automates protocol eligibility chart review and provides a curated list of their pre-screened patients with a high potential for enrolling.

With Site Explorer, sponsors can easily find the right patient cohorts with the matching trial sites. They can model study protocols and identify optimal sites based on inclusion and exclusion criteria.

If a customer has an unusual study topic and needs a more sophisticated search, we can build a customized algorithm to uncover more specialized information.

What are the primary advantages of working with Verana Health that potential clients should know?

With clinical trials, data is essential for decision making and finding actionable insights. So simplified access to exclusive data registries is invaluable. 

At the same time, from a project management perspective, we do a really good job of operationally aligning with the client and being creative to meet their needs. We’re very service-oriented, and nice to work with. 

We have in-house experts and medical advisors, experience dealing with every aspect of supporting clinical trials, from site engagement to qualitative science, data science, data engineering and software engineers. We partner to help clients find patient cohorts and patients, and to process and enroll more efficiently. 

Outside of work, what captures your interest? 

I’m fortunate to live in San Francisco, which is a very hilly city, and one of the things I love to do is hill walk. Little day hikes in the city. I live in a neighborhood almost like a small village, so it’s a good community with friends. Coming from exercise science, I try to include  some daily exercise!

Watch a quick overview of SiteExplorer and Verana Trial Connect

Contact us for more information on support for clinical trials.