The development of groundbreaking and vital medicines relies significantly on the success of clinical trials. However, one of the largest hurdles that clinical trials face is effective and efficient patient recruitment. Approaches for patient recruitment include identifying the right study sites. Sponsors aim to identify high-volume sites with patients who fit specific inclusion/exclusion criteria. Traditional methods for site selection often begin with the usual suspects: previous interaction with the site, the home base of key opinion leaders, or investigators with overall patient experience. While in some cases, these methods have been successful, clinical trials are still marred with obstacles – many fail to meet enrollment timelines, are underpowered, and some are even terminated due to low accrual rates. Read this white paper on how Verana Health used a data-driven approach to help streamline site selection for a recent client.
Read this white paper on how Verana Health used a data-driven approach to help streamline site selection for a recent client.
In addition to selecting study sites with high potential for yielding enrolled trial participants, another source of recruitment challenges arises from pre-screening requirements which require clinical research coordinators and other personnel to spend time and effort identifying which of their patients fit the correct clinical characteristics.
“Identifying patients based on inclusion/exclusion criteria is a nontrivial task in any setting, but in this case, it’s almost impossible for the study coordinator to spend enough time to exhaustively go through all of the charts and find the things that are indicative of good candidates to screen for the trial,” says Michael Mbagwu, MD, a Stanford University School of Medicine ophthalmologist and Senior Medical Director at Verana Health
Improving patient recruitment in ophthalmology trials
Verana Health is helping to streamline patient recruitment and site selection processes with an innovative, data-driven approach. Most recently, a client was looking to recruit patients for their phase 2 study, which was focused on patients who experience chronic pain (chronic induced corneal pain, CICP) after laser refractive surgery. CICP is a condition with a complex patient journey and no diagnostic code, making patient recruitment difficult to navigate through standard means. By providing expertise in healthcare data and analytics, Verana Health was able to support this client with both study site selection and, under the direction of the site, patient identification through its exclusive data partnership with the American Academy of Ophthalmology IRISⓇ Registry (Intelligent Research in Sight).
The IRIS Registry is the largest specialty society clinical data in all of medicine with electronic health record (EHR) data from over 78 million de-identified patients and approximately 16,000 contributing clinicians. Verana Health helped alleviate some of the challenges associated with patient recruitment for this CICP trial by working with the client’s medical team to translate their detailed patient journey work into an algorithm to identify potential patients who may be a fit for the study. In doing so, Verana Heath was able to comb through a large volume of EHR records with clinician notes to surface a group of patients who were potential fits for the study.
The lead research coordinator of this site credited Verana Trial Connect for their recruitment success, “Our ophthalmologists see hundreds of patients daily, therefore Verana Trial Connect has allowed us to narrow down potential patients for the trial.
Verana Health has the ability to uncover study sites that might be missed by sponsors. Notably, Verana Health linked the client with a multi-specialty practice that helped lead to successful identification of patients and ended up being one of their highest enrolling sites. This site utilized Verana Trial Connect, which is a tool that efficiently checks patient records, to identify a group of potentially eligible patients and reduce some of the prescreening burden placed on site coordinators. The lead research coordinator of this site credited Verana Trial Connect for their recruitment success, “Our ophthalmologists see hundreds of patients daily, therefore Verana Trial Connect has allowed us to narrow down potential patients for the trial. Patients are generally very receptive to our invitation to participate in the study and are oftentimes eager to start! The portal has been very easy to navigate and update throughout the course of the trial as well. Overall, we are very happy to be able to utilize the Verana Health database for the study.”
To learn more about how Verana Health was able to support this phase 2 study and identify new sites for the study sponsor, view the white paper here.