PPD™ Vestrum Health™ Real-World Data: A game changer for ophthalmology clinical trials 

One of the most prevalent issues drug developers face when developing new ophthalmology therapies is the limited number of patients available for trials targeting specific indications. This problem is exacerbated by the high number of competing trials in many indications, particularly for conditions like geographic atrophy, which have few treatment options. Additionally, rigorous inclusion and exclusion (I/E) criteria add layers of complexity, leading to higher screen failure rates, the reduction of patient pools, and slowing recruitment, all of which can lead to serious delays in study timelines. 

To succeed, sponsors must have access to disease-specific expertise and the experience necessary to address these challenges early in the planning process. Drug developers must also balance these considerations while managing site quality and communication. With so many competing elements at play, small missteps can lead to sites facing debilitating delays, hurdles, and the need for protocol amendments. However, with the right tools, resources and expertise, these problems can be adeptly navigated to optimize a therapy’s path to success. 

Succeeding in the face of common challenges 

There are a few areas of focus that, when approached strategically, allow sponsors to avoid many of the most common challenges within ophthalmic drug development. When drug developers are equipped with the appropriate expertise, employ innovative approaches, select the right sites, and effectively optimize protocols, they are able to efficiently manage the clinical development process. With the right tools and team in place, these elements help facilitate a smooth and seamless drug development lifecycle and mitigate common hurdles like missed deadlines. 

Expertise and relationships 

Leveraging the best expertise while fostering strong relationships with site staff and investigators is critical to ensure a smooth clinical trial. Collaboration with partners and vendors, such as equipment and central image reading vendors, can make or break a trial. Clinical development teams that have built strong relationships with study sites and key opinion leaders are able to facilitate success through these connections. However, sponsors must invest significant time to build these relationships. Those that have the necessary capabilities and experience at their disposal — or commit the time needed to grow these areas — are better positioned to navigate these relationships with ease.  

Innovative approaches 

Using innovative delivery methods to increase adherence and efficiency is another approach to enable success in an ophthalmology clinical trial. This can be supported by the implementation of digital and decentralized tools that allow for more flexibility and accessibility for trial participants. Additionally, the recruitment process is streamlined when sponsors are highly intentional about I/E criteria that maximizes the available patient pool while still satisfying regulators and ethics committees. 

Strategic site selection 

It is also essential to not only identify the right sites, but to do it early in the planning process. The earlier a team determines the right sites for their study, the more likely they are to properly plan around regulatory requirements, site expertise, and availability of eligible study candidates.

Protocol optimization 

Avoiding protocol amendments is one of the best strategies for a smooth clinical trial, but this requires a deep understanding of and scenario planning for the potential issues that may arise. Balancing regulatory requirements with expeditious enrollment is key in planning a successful trial.  Sponsors ensure endpoints are protected and quality is maintained to plan a robust trial with the best chance at obtaining desired labeling claims.  

Your key to overcoming these challenges: Our Vestrum Health Real-World Data network 

PPD^™ Vestrum Health^™ Real-World Data—established in 2013 as Vestrum Health by retinal specialists—is a solution based on a robust network of sites resulting from years of fostering strong relationships with investigators dedicated to clinical research. Leveraging data from 3 million patients and 14 million patient visits via our relationships with more than 380 retina specialists, our Vestrum Health Real-World Data team provides invaluable insights and comprehensive data analysis.   

Key capabilities of the Vestrum Health Real-World Data team: Strategic enrollment and protocol optimization  

As part of the PPD™ clinical research business of Thermo Fisher Scientific, our direct access to sites’ EHR data allows us to programmatically identify sites with patients that meet the required criteria, thus reducing site burden. This approach, enabled by Vestrum Health Real-World Data, quantifies how the potential patient pool is narrowed by each I/E criterion prior to the study initiation. Specifically, we provide sponsors with the ability to run through their protocol or initial protocol design before it is finalized. This allows drug development teams to pressure test their I/E criteria, allowing them to catch issues or gaps before the trial start date. Addressing protocol issues or amendments early can prevent significant costs in terms of time and money. This combination of capabilities enhances a sponsor’s ability to optimize their trial and make confident decisions. From the site’s perspective, this support enables them to focus more on patient centricity and retention.  

Unique integrated expertise and tools 

The seamless connection between our clinical trial delivery team, scientific team, and our integrated Vestrum Health Real-World Data team results in combined capabilities that foster accelerated studies and cost savings. The synergies within our team and the sites we are connected to strengthen collaboration and communication across services. Our teams are comprised of experts in their respective fields and have demonstrated a track record of success in ophthalmic clinical development. Together, under the same organization, Vestrum Health Real-World Data and our PPD scientific and operational services team are greater than the sum of their parts, creating a suite of tools and resources that are unmatched in the drug development industry.  

Enabling customer success 

By understanding challenges before a trial begins, a sponsor can further evaluate the I/E criteria and assess the additional support needed to support successful enrollment, without costly delays. Drug developers that have partnered with us to employ this technology have seen strong returns on their investment, putting them ahead of competitors and streamlining their time to processes.  

Hear from our partners 

Working with the PPD clinical research business and the Vestrum Health Real-World Data team on a recent global Phase III registrational trial in geographic atrophy was a game-changer for our site. Even though we came in late—activated in March—we still finished as a top 10 U.S. site by July, with the highest randomization rate and lowest screen-fail rate in the country. Their data-driven pre-screening and hands-on site support made patient identification seamless and efficient. We enrolled fast, we enrolled right, and the trial wrapped nearly two months ahead of schedule. That kind of performance is exactly why I’d trust them to deliver on any large, complex Phase III program.  

-Deepak Sambhara, M.D., Eye Clinic of Wisconsin 

The team at the PPD clinical research business combines global reach with rapid site-level responsiveness, warm relationships with PI’s and site staff, and CRO management contacts who are eager to keep the company as clinical trial administrator of choice in the complex, active and exciting modern era of retinal clinical science. Having recently wrapped up enrollment for another global Phase III geographic atrophy (GA) trial in which we participated as a high enrolling site, I feel confident the PPD clinical research business could achieve the same success with other global Phase III GA trials as well!

-David Eichenbaum, M.D., Retina Vitreous Associates of Florida 

Our competitive edge 

Our competitors lack the same level of access to the Vestrum Health Real-World Data team’s extensive network and data for clinical trial enrollment and protocol optimization. While most competitors provide only a list of potential participants, our data and network enable us to offer bespoke services that are designed around each site’s needs. Our capabilities include:  

• Site relationships that allow us to work as an extension of their office with remote access to the EHR, as well as collecting a deidentified dataset from the EHR to aid in queries for patient identification. 
• The ability to flag charts electronically in sites’ own EHR to ease participant identification. 
• Full support throughout the clinical development process. 
• The ability to analyze the effects of several I/E criteria considered together. 
• A team of certified ophthalmologic techs that facilitate and validate the service. 

Other providers in the field do not have access to this level of dynamic data-based decision making. Our multi-faceted approach means that timelines are optimized, leading to cost reductions and increased efficiencies that our competitors don’t have the resources or expertise to replicate.  

Transform your ophthalmic clinical trials 

Partnering with the PPD clinical research business of Thermo Fisher Scientific, combined with our in-house Vestrum Health Real-World Data solution, is a winning strategy for any retinal ophthalmic therapy hoping to reach market. Our internal data analysis resources and capabilities are unmatched in the rest of the industry and our clinical development teams have a history of success advancing ophthalmology drug products throughout the development process. For sponsors that want the very best — our team is here for you.