Findings based on study simulations detailed in new white paper from Spencer
MORRISVILLE, NC – July 17, 2019 – Medication adherence plays a substantial role in the success of clinical trials, according to data presented in a new white paper issued by Spencer Health Solutions. The white paper was released at the Drug Information Association’s 2019 global annual meeting.
“The impact of medication adherence on the cost and efficacy of clinical trials stands out when looking at the data,” said Alan Menius, chief scientific officer at Spencer Health Solutions and a co-author of the white paper. “Of course, adherence is one of many factors in clinical trials. These findings suggest that it may play a larger role than what has been generally accepted.”
Using the results of hundreds of simulated hypertension studies, Spencer found that low adherence increased the likelihood of stroke by 42 percent. Low adherence also was found to require a 40 percent increase in patients needed to generate a successful trial.
The white paper, “Better Adherence, Higher Engagement: Finding the Clinical Trials Sweet Spot,” describes how simulations were used to estimate the impact of adherence. A published stroke study formed the basis of the simulations. The U.S. Food and Drug Administration considers simulations to be important and relevant to clinical trials.1
The analysis was designed by Exploristics, which provides analytics, statistics, and exploratory data analysis, modeling and simulation services. Aiden Flynn, the founder of Exploristics, co-authored the white paper with Menius.
“Trial sponsors and clinical research organizations need to know which factors play the biggest role in the success of a trial,” Menius said. “These insights may help sponsors decide where to focus when trying to manage time and cost.”
The paper is available for download using this link.
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Exploristics provides analytics, statistics, exploratory data analysis, modeling and simulation services. They have unique expertise in handling large data resources, including Clinical Trials, Biomarker, Pharmacogenomic, Imaging, and Observational data.