Applied Clinical Trials

Today in this blog topic we shall discuss in short the roles of technology in clinical research industry or fields.

It is quite noticeable the vast array of technological solutions that is bringing lots of changes to the clinical trials process. From a growing body of literature to webinars to multi-day conferences, it is clear that technology is key to a world focused on making great improvements such as rapid study start-up, streamlining transmission of clinical trial data, and supervising how studies are carried out.

Why now?

The advent of cloud-based capability could not come at a better time. It coincides from the FDA to adopt technology, as evidenced by the release of two guidance and one draft guidance on this subject.

New solutions

With the cloud gaining popularity, so, too, are the technologies it supports, such as eTMF, eSource, RBM and advanced-generation clinical analytic interfaces built on virtual, on-demand data warehouses. A brief review of these technologies says how they are essential to helping move forward the clinical trials.

Electronic trial master file (eTMF)

The eTMF refers to the electronic version of the important documentation required to conduct a clinical trial and assess the quality of the data produced. Initially, when the TMF went electronic, it was generally maintained on an in-house client server and worked mostly as an electronic file cabinet whereby paper documents were scanned and archived, but was significantly static. Over the time, this format matured to a cloud-based solution that has massive amounts of interactive data that could be used for strategic planning of an ongoing trial. To mention, the eTMF provides greater visibility of data among stakeholders, documents are always ready for audit, and there is working as a business planner tool, without need to maintain the IT infrastructure in-house. 

eSource

Another solution, eSource, is gaining rapidly, especially since September 2013 release of the FDA guidance on the subject, which encourages its utility. The guidance says. eSource is defined as data initially recorded in electronic format. Data taken during a study visit can be entered directly into an electronic case report form that is called eCRF, a process that has the advantage of lowering errors by removing the step of first writing on paper and then transcription.

eSource addresses one of the major issues of EDC: the need to transcribe document sources into CRFs.  With eSource, clinical information flows directly into the study’s clinical trial database in near real time or real time, permitting for earlier notice and a rapid start to data analysis. 

Risk-based monitoring (RBM)

RBM uses targeted approaches to remote or cloud-based supervising of subsets of the clinical trial data, and can take the form of statistical risk-based algorithms and partial SDV based on fixed risks tied to the protocol. TransCelerate BioPharma, a non-profit focused on innovation in R&D, has provided further clarification into RBM through its position paper on the subject. It explains 5 steps, starting with risk evaluation, and ending with looking after execution. As a part of this effort, TransCelerate makes frequent references to use of technology for central or off-site monitoring to make the wished efficiency profits without affecting patient safety. The intentions are to reserve onsite monitoring to further support patient safety, site process, and data quality.

Technology driving changes

With the use of the described cloud-based technologies, a change in the current business model is needed. Current model was developed decades ago, in response to a time when clinical trials were very different from today’s global multi-site approach. Even the introduction of EDC, which brought huge strides in terms of edit checks, a better query process, and rapid viewing of clinical trial data, was still rooted in the conventional business models with legacy approaches to supervision and validation. By comparison, other data-heavy industries have changed their business models, and research suggests similar changes in the clinical trials sector.

Not surprisingly, the industry is in different stages of adoption, reflecting different sizes of companies and levels of sophistication among stakeholders.RBM is a technology that helps to make many transitions. An industry expert, Whitaker appreciates and welcomes the changes offered by technology, but feels that, at least to some degree, the human touch is getting lost. She said her site is starting to notice that streamlined processes and technologies are shortening the research phase by getting the data collated and meeting contracted timelines, but we the human element with RBM is getting lost. The monitor can see the clinical trial data remotely, but they aren’t seeing documentation of the informed consent process or the actual signature of the investigator on various documents. Whitaker added that they aren’t seeing any notations, like why the patient was out of window or why certain factors were not reportable to an IRB.  

We conclude the discussion here. Hope you liked it and let us know what else could be the advantages of technology in the field of clinical research trials.

Stay connected with us for more discussions to come. Let us know your experience with us in the comment sections below.

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