Implementing eClinical Tools: A Daunting Task

December 1, 2018
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-12-01-2018, Volume 27, Issue 12

Survey highlights thoughts on digital integration, managing data sources.

This fall, our survey partner SCORR Marketing and

Applied Clinical Trials

set out to find out what the eClinical technology landscape looked like. The full results of the survey is downloadable

here

. Like

other recent surveys and conferences

conducted in eClinical, an inconsistent and frustrating picture emerged.

And it is no wonder. Bracken Marketing, an agency that is dedicated to eClinical providers, offered an infographic of over 190 vendors in the eClinical space, segmented by their core expertise. That’s a lot of choices and clinical trial parts to be managing. For example, our survey found that 54% respondents said their relevant clinical function team was the primary decision-maker on a software purchase, as well as the person who determined if a solution was needed at all. Anecdotally, this has led to a phenomenon of duplicate software purchases at large pharma or situations of duplicate efforts by therapeutic teams in reviewing technology products. In fact, in the article linked above, Shelley Padgett, senior director of IT at Eli Lilly & Co., observed the exploding number of third-party solutions involved in the company’s infrastructure, as well as the amount of data and platforms. Her goal now? To establish a model that brings together its workflows but with a smaller set of platforms.

Quality concerns

Similarly, in an article by Jim Streeter, global vice president, life sciences product strategy, Oracle Health Sciences, which is in this issue and based on a survey by the company, it revealed that more than half of the clinical data professionals surveyed are not confident in the quality and completeness of their clinical data from an audit and compliance perspective. And, again, not a surprising revelation, given the number of vendors in the eClinical space. The Oracle survey reported that 50% of respondent companies have between one to five data sources for a typical clinical trial; 37% between six to 10; 7% have 11 to 15, and 6% have more than 15 data sources.

This fact was also not lost on the respondents to our survey. To the question, “Does your organization currently have an initiative to integrate its clinical trial systems and processes?” 55% responded yes; 25% responded they were in the planning stages; and 20% said they did not or were unsure.

On a different note, however, our survey found 47% and 27% of respondents found the benefits of digital data collection to their organization to be improved data quality and access to real-time data, respectively. Further, 40% of the respondents noted that, overall, these technological advances provide better quality data, and 25% optimistically say that technology leads to more cost-effective clinical trials.

RBM impact limited

One area of clinical trials that seem poised to take off and provide that promised cost-effectiveness was risk-based monitoring (RBM). Five years ago, the FDA initiated back-to-back guidances on RBM and then using eSource in clinical research. Unfortunately, as this issue’s article, Barriers to RBM, as well as this peer-reviewed article online note, that success has not been found. From the latter article, the authors state: “Since publication of the regulatory guidance on risk-based monitoring five years ago, the concept of centralized monitoring has developed amid the emergence of technological enablers that make clinical research more data-driven than ever. ...Despite its unique potential for improving the quality of clinical trials, centralized monitoring can appear so technical that sponsors often elect to renounce its use in favor of costly and less efficient traditional monitoring methods.”

And in the former article, the barriers to RBM adoption ranged the gamut, but technological barriers included having the technology tools work together is difficult; difficult to understand the different RBM approaches; difficult to choose which approach is best for our organization; and technology tools are confusing, difficult to know which are needed.

To the last point-technology tools are confusing and it’s difficult to know which are needed-that is indeed daunting. And not just relegated to choices in monitoring. In our survey, obstacles that have hindered your organization from implementing technological and eClinical solutions included, in order of highest to lowest, cost; fear of change; data integrity/security; insufficient collaboration; lack of resources; and lack of internal support/training.

Level-out looms?

With the future of clinical trials looking to move studies closer to the patient’s point of care, become increasingly smaller and more targeted, and introduce analytics and more reliable measures of mHealth to help virtualize trials, the plethora of software solutions may even out and become less daunting. In the meantime, companies can be assured they are, in many cases, gaining the benefits they originally hoped for in their digital choice, and comforted that others face the same confusion.

 

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lisa.henderson@ubm.com. Follow Lisa on Twitter: @trialsonline

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