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eClinical for Today and Tomorrow

As posted in DIA's Global Forum:

Jonathan Andrus

As eClinical concepts continue to emerge throughout the drug discovery and development spectrum, they become more important and frequent topics for discussion among industry professionals of every function and discipline. Jonathan Andrus, MS, CQA, CCDM (BioClinica, Inc.), who serves as Chair of the DIA eClinical SIAC and also on the Board of the Society for Clinical Data Management, shared these thoughts on the importance of eClinical initiatives to industry, and the value of the eClinical SIAC to the DIA member and volunteer community.


There has been much discussion but seems to be precious little consensus: Like the word “interface,” is “eClinical” a noun (a thing) or is it a verb (an action or process)?

eClinical is a thing, or a series/collection of things. It constitutes the process or conduct of clinical trials in an electronic manner. It is the application of a thing or things (a noun or nouns) to a verb (action or process) to enable the management of a clinical trial. eClinical tools are a noun, but their application to our processes is a verb. How you use it within the clinical trial environment is what’s important.


If most experts agree that “eClinical” and “electronic data capture” are related but are not synonymous terms, then why do they seem to be so often used interchangeably?

They are absolutely related, but they are not the same. EDC, electronic data capture, is one of many eClinical tools that are used by clinical research professionals to complete clinically oriented tasks (data collection, monitoring, site payments, randomization, study drug management and patient-reported data collection, to name a few). eClinical allows for data to be collected in a less arduous and manual manner. In talking about eClinical, people often refer to EDC because that is the most commonly recognized, and had been used probably the longest and most widely, of eClinical tools.


How can eClinical initiatives help advance the pharmaceutical industry’s current emphases on transparency and drug safety?

Through the use of these eClinical tools, stakeholders (professionals in clinical, data, and statistics departments, plus senior management) can have access to their data in a more real-time and in theory, better quality way. Data can be quickly accessed and presented to a wide variety of audiences to provide early detection of trends in safety, enrollment/recruitment, data quality and study design. These tools can be used to improve overall data quality and lead to quicker, more assured study decisions. This also leads to the transparency you suggest in your question. Through the use of eClinical tools, one can gauge data quality and data integrity by looking for query trends, data changes, study design changes, etc.

Further, using web-based reporting tools provides the transparency needed to keep an eye on all eClinical data. All parties involved can gain insight into the data and determine how personnel are performing. Are they conducting their site visits when expected? How much work are they getting done when they are onsite? What additional/refresher training might be needed to address observed trends? How are the data managers doing? Are queries being cleaned up and addressed in a timely manner? How is coding moving along? Judging from the way that AE and ConMed terms are being reported, is additional training needed? What are the type and significance of adverse events that are being reported? These are just some examples of the transparency and drug safety items that can be addressed through eClinical!

It’s not just about data management or validation or ePRO: It’s about all the different eClinical tools and processes. We’re all clinical research professionals. Maybe a subject matter expert who’s a data manager shares insight or guidance with a CRA to help them better perform their role during monitoring; conversely, the CRA can say, “While I’m monitoring, it would be really helpful if you were doing these things from a study design perspective or the way that you word your queries.” How can you use these tools to make the clinical trial process – the verb – much more effective by using the tools – the noun – to improve data quality, transparency, and safety. How are we doing from a query management perspective? Are my monitors performing in accordance with timelines? Are there areas of the study design that are confusing the sites, which we’re seeing through an increased number of data discrepancies? Maybe it requires refresher training – you know, actually use eClinical tools to help affect study outcomes.


What needs of the clinical research/drug development community can the eClinical SIAC help meet?

We are looking to tackle topics related to the successful implementation and use of eClinical tools in the conduct of clinical trials, and how to properly deploy and utilize these tools to further advance issues previously discussed: How do we integrate and interface more effectively with existing tools to help reduce redundant data collection? How do we utilize standards within eClinical to help speed and improve the quality of planning, designing, and developing clinical trials? What areas are people within industry struggling with? How can we work more effectively across all of clinical research? We want to get away from best practices for the data manager, or best practices for the CRA, but rather embrace more of a model of best practices for the Clinical Research Professional. How can the functional, specific roles within the clinical research profession work more effectively together? What can a data manager share with a CRA that would make their job more effective and more fulfilling, and in turn, what can a CRA share with a data manager that would help to improve the processes that they employ in eClinical? Getting all clinical research parties working toward a more common and cohesive goal is a big goal of the eClinical SIAC: We are looking to tackle topics related to the profession in a way that brings together different subject matter experts to arrive at cohesive conclusions.

One of the reasons I was drawn to the eClinical SIAC is that eClinical is kind of a “clearing house” of all these different tools, processes, people, and resources that need to come closer together. These eClinical tools are forcing us to work more closely together, but people are still kind of pushing back. I really feel strongly that the eClinical SIAC is a great place to start to break down some of those industry “silos.” eClinical embodies and covers all these different areas. I cannot emphasize this enough: We’re not data managers, not CRAs, not statisticians, but we’re all “CRPs,” clinical research professionals. And if you view it that way, this eClinical SIAC should really be geared to serving these needs and developing best practices and guidance that benefit all of us, not just one single group. That’s the area that can be bridged with this SIAC and what will be of most interest to our association.


What did we not ask you that you would like to share about eClinical initiatives?

It is important to note that anyone can get involved and be a part of this change. Don’t just sit back and wait for a society, association, or consortium to bring standards and guidance to you. Be a part of its development. Have a say in the future. Be on the cutting edge of industry changes. Be a participant, not a spectator! To get involved, share ideas or brainstorm, feel free to contact me directly at jonathan.andrus@bioclinica.com 

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