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As in other needs in the clinical trials chain, endpoint adjudication is an area that can be greatly improved by technology.
We recently published initial results from the Endpoint Adjudication Survey (designed by The Clinical Endpoints Independent Review & Adjudication Group and Ethical Clinical, and publicized on LinkedIn and through Applied Clinical Trials), and results have shown that endpoint adjudication technology solution adoption is widespread, however, personnel experienced cultural challenges with executing endpoint adjudication with technology solutions.
This article will focus on (a) understanding how functions and organization types feel regarding continued use of endpoint adjudication solutions, (b) uncovering organization types and functions that have not been exposed to endpoint adjudication software, and (c) differentiating behaviors between Excel-based and endpoint adjudication technology system users. Click Here to Register for CBI’s Endpoint Adjudication Event, May 4-5, 2016 in Philadelphia.
Endpoint Adjudication Software: A Want by Most Executives
It is clear that most executives want to use endpoint adjudication specific software, according to the survey. When respondents were asked about their plans on using endpoint adjudication software, most have indicated that they plan to use one in the future (Figure 1).
Figure 1 unveils an interesting trend; approximately 43% (13) of those who use traditional tools (i.e., Excel, email, etc.), plan to use an endpoint adjudication specific software in future studies, whereas the remaining 56% (17) of traditional users (representing 27% of all respondents) have not heard of endpoint adjudication specific software. This trend may suggest that there is a large group of traditional users who are not aware of endpoint adjudication specific software, and traditional users who are aware of software solutions are more likely to use them in future trials.
There are Organizations and Functions who are not aware of Endpoint Adjudication Software
Given the aforementioned findings, we delved deeper into the data to specify organization type and function behavior and attitudes towards endpoint adjudication software. Figure 2 illustrates that most organizations plan to use endpoint adjudication specific software in future clinical studies, with the majority of known organizations in pharmaceuticals (with a 68.4% rate), followed by Academic Research Organizations (at 61.1%), and CROs (at 57.1%). When analyzing those who do not know of any endpoint adjudication specific software, Figure 2 insightfully reveals that CROs exhibit the highest rate of not knowing that endpoint adjudication software exists (at a 42.9% rate), followed by pharmaceuticals (31.6%), medical device companies (25%), and AROs (22.2%).
Figure 2 may imply that a notable amount of personnel at CROs and biopharmaceuticals, have not been exposed to, or are aware of endpoint adjudication software solutions.
Figure 3 also depicts that most functions plan to use endpoint specific software in future clinical trials. Naturally, known functions, such as endpoint adjudicators (77.8%) and safety (100%) want to continue using software solutions in future studies, whereas data management (60%) and clinical operations (35.5%) followed.
It is important to observe in Figure 3 that 45% of personnel in the clinical operations function are unaware of endpoint adjudication software solutions. This observation is interesting because clinical operations personnel tend to plan and design study infrastructures for other functions, such as safety, and endpoint adjudication functions to use during clinical trial conduct. It is possible that the lack of knowledge in the clinical operations function is not creating opportunities for personnel in other functions to benefit from endpoint adjudication software.
“The clinical operations function is critical in triaging the operational design of clinical trials, which includes selecting endpoint adjudication technology systems,” said Mimmo Garibbo of Ethical Clinical. “Clinical operations personnel should be made aware that cloud-based endpoint adjudication software solutions exist, as such systems can reduce inefficiencies, and improve data quality in the adjudication process, and this is something that direct users in other functions, such as outcomes adjudicators, safety, data management, QA, and clinical endpoint committee members will appreciate,” added Garibbo.
Endpoint Adjudication Software is Increasing in Adoption with Users
Figure 4 demonstrates that most personnel currently involved with endpoint adjudication use a software solution. An overwhelming 68% (34 respondents) of those who are currently involved with endpoint adjudication projects are currently using an endpoint adjudication software, whereas the remaining 32% (14) use traditional models to conduct endpoint adjudication. Alternatively, 46.2% (12) of those who have previously been involved with endpoint adjudication studies, used software solutions, whereas 53.8% (14) used traditional models.
This data may suggest that the use of endpoint adjudication software solutions is becoming more widely adopted in newer studies compared to older ones, where traditional model execution is more common. “We are seeing more adoption and acceptability in endpoint adjudication software solutions, and clinical trial personnel see the value when presented with software solutions” said Garibbo. “However, it takes time for our champions to convince others to change their traditional endpoint adjudication processes,” added Garibbo.
In summary, we have identified that endpoint adjudication specific software solutions are increasing in adoption and awareness in the industry. Nonetheless, it is important to emphasize the observation that specific organizations and functions have still yet to become aware of endpoint adjudication specific software solutions. We expect that, with time, leveraging cloud-based endpoint adjudication software will become the norm in the industry, and that will increase, as clinical research entities and functions accept a culture of change and innovation, rather than hesitation and ossification.
Learn More at the 4th Annual Endpoint Adjudication Conference
and hear from FDA Senior Reviewer Andrew Farb, MD.