The achievement of the first patient enrolled (FPI) into a clinical trial is one of the most highly anticipated events of the clinical development process. The pressure to reach this milestone, whether to meet a corporate target or outpace the competition, is intense. As a consequence, in the rush to achieve FPI, thoughtful study design and reasoned start-up considerations are often neglected and may cause the study to start prematurely, increasing the likelihood the study will be delayed.
The industry does not often get protocol design right the first time, resulting in a negative impact to overall timelines and cost. 86% of clinical trials are estimated to experience delays, and 94% of clinical trials are delayed by over one month. The protracted timelines associated with the clinical development process directly correlate with increased costs and decreased revenues. Careful protocol planning is key to preventing design-related delays, which impede last patient out milestones and generate unnecessary costs associated with protocol amendments.
Key Issues to Be Addressed When Instigating a Clinical Trial
The Tufts Center for the Study of Drug Development, in a 2016 paper, found that 57% of protocols had at least one substantial amendment, with nearly half of these considered “avoidable”. Pharmaceutical companies can evade these expensive amendments by taking into account many different considerations before the study. In a recent article published in the November 2017 edition of the European Biopharmaceutical Review, experts from Medpace discuss key issues that need to be addressed when instigating the clinical development process. You can access the article in its entirety here.