Are Your Eligibility Criteria Costing You Time and Quality?
Protocol Pitfall Series - Issue #1: Eligibility Criteria
Author: Claire Dennis, Marketing Coordinator at ScienceMedia.
Clinical trials are the backbone of innovation in healthcare, but even the most promising studies can be undermined by unclear protocol design, especially when it comes to eligibility criteria.
This first in our Protocol Pitfall Series takes a closer look at how ambiguity in eligibility criteria can slow enrollment, increase deviations, and threaten study outcomes.
The Pitfall: Unclear Eligibility Criteria
In theory, eligibility criteria should help you define the right patient population with precision. In practice, this can often become a source of confusion. Are the criteria open to interpretation? Are all staff aligned on what constitutes "mild" versus "moderate" symptoms? Can site teams access the criteria quickly and confidently when screening?
Even minor misinterpretations can lead to protocol deviations, screening failures, and increased monitoring costs, not to mention delays in trial timelines.
A Smarter Approach to Training
That's where SMi Trial TM comes in. Our protocol compliance and risk-based training solution makes inclusion/exclusion clear and memorable. Staff can access their training resources from any device, right at the point of care or screening.
This approach results in:
Why It Matters
Eligibility criteria are often one of the first touchpoints your site teams encounter when launching a trial. Misalignment here sets the tone for downstream issues. With the right training tools in place, you can ensure clarity from day one.
Coming Next Month
Next in our series, we'll explore patient confusion around Investigational Medicinal Products and how SMi Engage, our neighboring clinical trial solution focused on study participants, can help to keep your trial on track.
If you're currently working on a study and experiencing challenges around eligibility, get in touch with us. We'd love to show you how SMi Trial can make a measurable difference.
To view more about this protocol compliance training solution for clinical trials, visit sciencemedia.com/trial.
Media Contact:
Claire Dennis
Marketing Coordinator
ScienceMedia, Inc.
619-339-0065
support@sciencemedia.com
Clinical trials are the backbone of innovation in healthcare, but even the most promising studies can be undermined by unclear protocol design, especially when it comes to eligibility criteria. This first in our Protocol Pitfall Series takes a closer look at how ambiguity in eligibility criteria can slow enrollment, increase deviations, and threaten study outcomes.
When it comes to clinical trials, staff and study participant training can be challenging, to say the least. With 90% of clinical trials failing and reported errors commonly sprouting from lack of site staff training and frequent confusion around trial protocols2, effective training is vital to a successful trial.
This all comes down to understanding the specific needs of that specific community, and none of us are the same. It's not always a one-size-fits-all. - Jocelyn Ashford on defining success in promoting health equity in clinical trials
The ultimate measure of success to me would be that we no longer need to focus specifically on this idea of diversity. It should automatically be embedded in everything that we do. - Jocelyn Ashford on defining success in promoting health equity in clinical trials
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To use a sports analogy, protocol deviations and violations in a clinical study represent unforced errors. The application of proper study training, like that delivered through SMi TrialTM, ScienceMedia's Protocol Compliance Management platform, has been proven to reduce and eliminate these entirely avoidable mistakes.
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My journey from participating in a trial, to supporting them.
Over the last four years at ScienceMedia, I have worked with dozens of study teams to understand the unique operational complexities of their clinical trials.
