Real-World Evidence and eSource in Clinical Trials

What Is Real-World Evidence?

Randomized clinical trials are operated under controlled conditions and are the fastest way of obtaining regulatory approval. However, they seek to answer the questions within a trial-defined frame and as such do not necessarily provide clinical relevance for the real-world environment.

Real-World Data in medicine is data obtained from many independent sources that follow healthcare outcomes in a diverse population. The data is primarily sourced from real-world settings, such as patient surveys, clinical trials, and observational studies. RWD data is mainly observational and related to real clinical practice, in contrast to strictly controlled experimental data provided by, for example, randomized double-blind clinical trials.

Real-World Evidence is data obtained from RWD, and it refers to data acquired via routine clinical practice. RWE is generated by analyzing data stored in Electronic Health Records (EHR) or other sources.

The data is exceptionally valuable in patient care, especially in the case of a rare or novelty disease when clinicians cannot account for the entire afflicted population. RWE analyzes the effects of drugs over a longer period, and it regards the usage and potential benefits, or risks of a medical product derived from analysis of RWD.

It is mainly utilized by pharmaceutical companies and health insurance payers to understand mechanisms of disease progression and provide relevant assessments and appropriate care. In the US, FDA uses RWD and RWE to monitor post-marketing activities and adverse events to make regulatory decisions.

RWD is sourced in patient registries, healthcare databases (EHRs), pharmacy and health insurance databases, patient-generated data, and e-health mobile devices.

Despite the increasing reliance on RWD, challenges and limitations exist that complicate the generation, collection, and use of this data. In order to reduce disparities in RWD collection, major software use or reference global code sets, such as SNOMED CT, ICD-10, and LOINC.

There is an increasingly growing managerial initiative to adopt global codes in local healthcare settings, which could facilitate worldwide data exchange and more quickly feed the RWD database with valuable information.

What is eSource in Clinical Trials?

Initial data within the study or “source” data is the data acquired from the central element of the study. In usual settings, the data is sourced manually, and further on captured to a distanced electronic device and fed to an online database.

eSource is the digitized process of data capturing on-the-spot, which eliminates duplicate entry while reducing errors at the same time. The technology promotes real-time entry of electronic source data during subject visits, thus reassuring for completeness and accuracy of entered data.

eSource increases the compliance levels of all parties by reducing redundant tasks while at the same time enabling remote monitoring. Platforms that allow eSource facilitate faster input of more precise data, perfect real-time data synchronization and reduce query resolution costs.

However, for full compliance, the users of the technology in healthcare facilities need to install eSource applications on their EHR systems.

The Difference Between Classical EDC and eSource

Although they are both designed for recording source data in a trial, there is a slight difference between the two.

The classical use of EDC is popular in clinical trials. However, the EDC templates can be filled at any time. Usually, trial operators or Clinical Research Associates can capture the data after the patient is gone or retype them from EHRs during scheduled visits. This delayed or double EDC feed often leaves room for errors.

On the other hand, eSource is a technology designed for clinical trial operators to be used by participating physicians at the moment of examination, thus inputting more valuable compliance-related information from the patient.

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