Speak Out

Contributed by:

Dr. George Atiee, Vice President and Medical Director, Worldwide Clinical Trials Early Phase Services Unit

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Are Early Phase Clinical Trials and Electronic Data Capture Still an Unlikely Pair?

At a time when technology is well and truly embedded within people’s everyday lives, the adoption of modern technology within clinical research has been an obvious step forward for the industry. Fifteen years ago, Electronic Data Capture (EDC) in clinical research was still a relatively rare entity. However, fast forward to today’s clinical trials and electronic data capture solutions have a proven track record of supporting studies of all sizes and complexities.

The potential gains from EDC are now well understood across the clinical trials industry, including reducing long-term study costs, minimizing errors, providing access to real-time data, improved data access for all stakeholders, and shortening trial duration. They also support a patient-centric approach to research.

That said, while the value of EDC in late stage clinical research is now well-established, adoption in early phase clinical trials has been slow. Historically, early phase trials—particularly among smaller and mid-sized organizations—have preferred paper-based processes due to short study durations and low subject counts, the perceived initial setup cost of electronic data capture systems and the additional training needed for study teams, to name a few reasons. But it’s important for researchers to understand that early phase research programs can also significantly benefit from EDC use.

Benefits to Electronic Data Capture Solutions in Early Phase Clinical Research

First, electronic data capture solutions allow for quicker patient recruitment and approval to participate in the study. They also facilitate faster and more accurate collection of data, meaning errors and potential issues can be detected much earlier, and the challenges that first-in-man studies represent can be addressed much quicker than with paper-based processes. By evaluating the safety and efficacy of information more quickly and efficiently via the supply of the data in real-time, EDC solutions ultimately support moving a new drug through the development process and to market sooner.

Recent improvements in technology also mean that setup and training times have been drastically reduced. What’s more, by using an EDC system in Phase I of a clinical trial program, sponsors will already have a validated system in place when it comes to moving to the next phase of development, saving valuable time and providing consistency.

Despite the recognized benefits, the reality is that adoption of EDC has remained relatively slow in early phase clinical trials. However, thanks to advances in technology, many of the barriers that prevented small and mid-size organizations from making the switch have been removed.

New Electronic Data Capture Solutions for Phase I Studies Expected to Accelerate Timelines and Improve Data Quality

Worldwide is transitioning to implementation of a total electronic data capture solution for its Phase I studies, which will significantly speed up how it collects data, as well as provide sponsors with the opportunity to review data in real-time, as a study progresses. Data is electronically delivered from the collection device (blood pressure machine/ECG) into the EDC system where it can be viewed by way of customizable reports. This ‘paperless’ approach will allow us to accelerate our study timelines and is expected to provide Worldwide and our study partners with higher quality data.

To learn more about Worldwide’s early phase clinical research services, please contact Worldwide Clinical Trials at +1 (610) 964-2000 or visit worldwide.com.

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