Clinical Trials Termination: What are the Causes and How to...

Pharma Tech Outlook: Pharma Tech Magazine

Clinical Trials Termination: What are the Causes and How to Overcome them?

By Pharma Tech Outlook | Monday, October 12, 2020

Clinical Trials The most challenging tasks in the clinical trials are recruiting study participants, which is possibly one of the biggest obstacles to success in clinical research. The recruitment of enough participants for a trial was identified as one of the top three pain points for clinical trial performance in Forte's national survey for 2017 by over 900 clinical research professionals. For many studies, low registration is a chronic problem. According to a survey (Applied Clinical Trial Survey), 19 percent of registered trials which was either closed or terminated was unsuccessful (85 percent) or terminated at an early stage due to unsatisfactory accruals.

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Understanding the different factors influencing an individual’s study decision often helps researchers to determine the root cause of inscription problems. The financial, ethical, and scientific concerns of clinical trials ending early (or terminated), and to the extent to which the outcome of the trials is disseminated and the reasons for their termination were not well identified.

As the highest cause for trial termination is the low accrual rate, it is not surprising that in each phase the average registration efficiency (the number of planned subjects divided by the actual number of participants) is below 40 percent. The lowest registration efficiency in all phases was at 32.1 percent in phase III and 39.8 percent in phase IV. The average number of registered patients also suffered from Phase I 19.1 to Phase III just 79.9.

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This data emphasizes the need to address problems of poor registration in clinical trials and in particular oncology, which was the most frequently, terminated area of therapy. The feasibility of clinical trials is essential for minimizing risks, taking into account competitive activities, and ultimately choosing the right geographic position, sites, and trial investigators. The most significant obstacles for people who would otherwise be willing to participate in a clinical trial are misinterpretation and lack of awareness. Adopting positive, advanced information on clinical research and encouraging more industry stakeholders to take part in outreach efforts is essential to address those obstacles.

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