How Skipping The CRO Helped RenovoRx Get Closer To Patients
A conversation with Leesa Gentry, chief clinical officer, RenovoRx
Most clinical trials involve three core parties in their execution: the sponsor, the site, and the CRO. Recently, this approach has maintained dominance, but from time to time, sponsor preferences change their approach and take execution of the trial into their own hands.
Such is the case with RenovoRx and TIGer-PaC, its Phase 3 head-to-head superiority trial for RenovoCath, which delivers chemotherapy intra-arterially instead of standard of care IV administration for those with locally advanced pancreatic cancer.
In this Q&A, RenovoRx Chief Clinical Officer Leesa Gentry explains why they decided to forgo a CRO partner, discusses their in-house expertise, and shares how the decision helped them get closer to patients.
Clinical Leader: Tell us about the TIGer-PaC team. What positions and people are in place, and what are their roles?
Leesa Gentry: Our team comprises full-time employees, contingent workers assigned specifically to the trial, and functional outsourcing. We have three full-time sponsor members: me, the medical monitor, and the clinical manager, who manages the day-to-day operations of the TIGer-PaC trial. We also have two CRAs, a data management lead, a biostatistics lead, a medical writer, a QoL nurse, a backup medical monitor, and another clinical operations professional who supports us as an embedded contingent worker assigned to the trial. Our clinical science and pharmacovigilance, central IRB, and translation services are functionally outsourced.
For this particular trial, you’ve opted not to use a CRO. What gave you the confidence to move ahead on your own?
This is a model I have employed before with significant success. Before joining RenovoRx, I led global infectious disease trials and regions with little clinical trial experience or CRO presence. TIGeR-PaC was already ongoing when I joined RenovoRx, but it is similar to my prior experience in a key area. TIGeR-PaC is evaluating a huge unmet medical need with multidisciplinary patient pathways that are new to CROs, even those that have relevant therapeutic area experience. From the beginning, we knew how to implement the trial and wanted to be a very hands-on sponsor, keeping project management in-house. This allows us to communicate quickly and effectively directly with sites. The ability to build trust and relationships across the multidisciplinary team at sites gave us the confidence to move ahead.
Would you consider working independently of a CRO and directly with sites again? Why?
Absolutely, and for one key reason: We regularly receive feedback from PIs and CRCs that we are the easiest sponsor to work with. When asked why, they typically note very quick responses to their questions, direct access to key decision makers, and flexibility to make the patient experience a positive one.
Given the close relationship, what are some things you’ve learned or heard from the site that you might not have if you had a CRO in place?
There are several examples I could share. Two that are perhaps most important in my view are the location and patient population-specific information on any enrollment challenges, and information about how patients are doing during and after treatment within the trial. We have found that there is definitely no one-size-fits-all solution to enrollment challenges. By getting more granular about how each site identifies potential patients and introduces the trial as a potential treatment option to both the patients and the tumor board review bodies, we have been able to craft site-specific enrollment strategies. For my own "why" it is also great to hear how patients are doing during and post-treatment, and that they can maintain quality of life.
We’ve heard some of the benefits. Now, were there any challenges to this approach, and how did you address or overcome them?
Well, mainly this is a commitment for all of us, and we all work long hours and wear many hats. It's a challenge to make sure everything is covered, but we communicate regularly as a team and support each other. The biggest challenge is flying the ship while building it. We have implemented regular key process reviews to ensure effectiveness, and we pivot if something isn't working well. This model is not something that will work for every company, but because of the passion and hard work of our team and the knowledge from early results that what we’re doing is really helping these patients, we’re excited to get out of bed each morning to work as hard as we do. But that doesn’t come without its own set of challenges. This work is not for everyone, and we did have some group turnover initially. Thankfully, that is something we worked through and built this passionate core team of efficient individuals who are in it to see this through to positively impact patient care.
How closely do you work with patients, and what lengths have you gone to uphold a positive patient experience?
We have implemented some protocol amendments to make the experience a bit easier and, from the beginning, we have tried to utilize procedures and tests as part of the standard of care to lessen the burden of participation. We have also provided support for transportation and lodging for patients who have to travel. Sometimes, patients or family members seeking information about the trial will contact us directly. We respond to them right away and help connect them to high-quality cancer centers close to them, even if they don't qualify for the trial.
What do you think this has done to contribute to the success of the trial?
The way we support our sites and strive to make the patient experience a positive one contributes to sites prioritizing our trial for enrollment and data cleaning, and sites can genuinely inform their patients that participation in the trial will be easy for them as they move through their treatment journey.
About The Expert:
Leesa Gentry brings 29 years of experience focused on improving clinical research programs in CRO, pharmaceutical, and biotech industries. Past employers include IQVIA (Quintiles), PPD, OmnicareCR, and Otsuka. Prior to RenovoRx, she was SVP of clinical operations at Evotec. At PPD, Gentry was global project manager and senior research specialist for clinical systems, where her team developed one of the pharmaceutical industry’s first clinical trial management systems. At Omnicare, Gentry grew the clinical research site network within long-term care; her work was featured in the Good Clinical Practice Journal. During her tenure at Otsuka, Gentry developed novel methods for improved, streamlined trial implementation in clinical operations, data management and third-party collaboration. Her work on registration trial implementation within resource-constrained environments was featured in the Bulletin of the World Health Organization. Gentry holds a B.A. in psychology and an M.S. in gerontology from the University of Central Missouri and an M.A. in psychology from the University of Mary Hardin-