Building a Single, Connected Platform for EDC, Randomization and ePRO

Leading pharma regulators such as the U.S. FDA continue to impose, and enforce, strict compliance standards with regard to approval of new drugs. The U.S. watchdog’s strict vigil means that for every new medical device or drug securing market release, thousands get rejected – cumulatively representing billions of dollars, and years of research.

One of the most important factors that decides whether a new drug or device will ever find its way to the public is clinical trials. Typically occurring in multiple phases, clinical studies attempt to conclusively determine whether the product under the lens is safe to be used by its intended recipients.

Starting with a handful of volunteers in the first phase, and concluding with a few thousand subjects, trials seek to establish the veracity of the drug/device in question by means of concrete data. This crucial data is collected through coordination between the clinical research team, clinical sites, contract research organizations (CROs), and the volunteers/patients. Also important is randomization (IVRS and IWRS), which ensures the reduction of any bias that could inadvertently affect the trial outcome.

The advent of digital technologies has revolutionized clinical trials. With electronic data capture systems (EDC), the process of collecting and analyzing user data has been streamlined, leading to a significant increase in time to market for new drugs and medical devices. Also emerging on the scene are electronic patient reported outcome (ePRO) systems, which leverage ubiquitous smartphones and computers to simplify data aggregation across patients/volunteers, and ensure regulatory compliance. This dynamic has not only removed the various complexities associated with storing data on paper, but has also made the data far more accessible, and easier to analyze.

However, in the course of using these tools, clinical research teams often come across different electronic systems and interfaces. So, the team might find itself using a particular EDC system for CRF, and an entirely different interface for patient reporting outcome.This is because trial sponsors are usually wary of building integrated, custom tools that combine CRF and ePRO data, due to the complexity and investments involved in terms of time and resources.

As a result, the researcher must switch between the two different data streams while analyzing the results. What’s more, the divergent data streams would eventually have to be combined in order to provide a complete picture. This process is far from being smooth, as it introduces additional complexity, and even delays trials because of data synchronization and matching issues.

The next step in the evolution of the trials industry is the adoption of end-to-end systems that combine the different eClinical tools used for data collection and analysis. These systems can provide a host of benefits to the trial program including:

• Single-platform access to subject assessment and visit data
• Investigators tracking subjects’ data entry habits through time stamps embedded with ePRO and ensuring compliance
• Ease of comparing administrative and subject data to reconcile discrepancies
• Execution of more comprehensive randomization criteria

While randomization and ePRO would usually be standalone tools, trial sponsors and CROs will do well to consider combining them to create an end-to-end, connected, holistic offering. Such a platform can provision data concerning randomization plan generation, subject randomization and ePRO, and be accessible with a single login. Institutionalizing this offering would allow the research team to store, view, extract, and analyze data in a seamless, hassle-free fashion.