One of the critical factors determining the success of a clinical trial is the selection of appropriate clinical sites that have evidenced access to specific patient populations. Siting can significantly impact a trial’s efficiency, cost-effectiveness, and ability to generate robust, reliable data.
Patient recruitment accounts for 32% of all trial costs and patient drop out averages 18%, according to Deloitte figures. A new Clarivate report: Harnessing the power of RWD in clinical trials, explores how trial sponsors are thinking more strategically and incorporating real world data into their trials.
Real World Data
In recent years, the use of real world data (RWD) has emerged as a powerful tool for enhancing clinical site selection. RWD encompasses a wide range of information, including electronic health records (EHRs), insurance claims data, patient registries, wearable device data, and even social media content.
In addition to clinical data tied to sites and investigators, RWD allows trial sponsors to know which investigators have experience in conducting a clinical trial in their patient population. Importantly, it can help to identify those PIs that are more likely to have access to their specific patient population of interest.
In therapeutic areas where there is competition for trial participants (e.g. oncology), trial productivity is essential. Identifying sites with oncologists and clinical staff that have expertise in treating a specific cancer type is critical. RWD sources such as cancer registries hold a lot of applicable information on the prevalence of specific cancer types, while patient databases and cancer centers’ historical data are valuable sources for understanding the number of eligible patients and their willingness to participate in clinical trials.
In areas such as rare disease, where patients may be few and often unevenly geographically distributed, RWD can help to optimize site feasibility by adding information from EHRs, patient registries, and claims databases to augment transparency around disease prevalence and patient demographics.
Drinking from the firehose
Valuable real world data is abundant but disjointed, being scattered across myriad formats and public and private databases. This poses a huge challenge for effective utilization, especially for small-to-mid-sized companies. Fortunately, numerous entities, including non-profits, consortia and commercial enterprises, are gathering and centralizing this real-world data, enabling its meaningful application.
These include patient networks such as PatientsLikeMe, the Innovative Medicines Initiative’s EHR4CR project and the Sentinel Initiative, created by the U.S. Food and Drug Administration.
The importance of trusted and robust data sets that can be joined up and used in tandem cannot be overstated. Clarivate’s Cortellis Clinical Trials Intelligence product overlays clinical sites with incidence and prevalence data, allowing trial planners to see epidemiological data in relation to clinical sites.
On top of this, Cortellis Clinical Trials Intelligence has recently incorporated U.S. claims data, meaning that those using this service can analyze site information overlayed with epidemiological data, and from there can access individual site details for a U.S. hospital to see the claims data in the past 12 months. Having access to clinical data with epidemiological and real-world data, all in one offering, can streamline the site selection process.
RWD is transforming the landscape of clinical site selection, offering a data-driven, patient-centric approach to trial planning. By harnessing the power of data, pharmaceutical companies, research institutions, and healthcare organizations can enhance the efficiency, diversity, and relevance of clinical trials, and thereby realize faster drug development, better treatment options, and improved patient outcomes.
The integration of RWD into clinical research is likely to become even more pivotal in shaping the future of medicine. If trial sponsors can access this data in a trusted and layered way, RWD will save dollars and lives, a win-win for all stakeholders in the healthcare ecosystem.
To learn more about the use of RWD to accelerate clinical trials, download the report, Harnessing the power of RWD in clinical trials. You can learn more about the Clarivate Cortellis Clinical Trials Intelligence solution here.