subject: Clinical Trials - The Importance Of Patient Enrolment And The Role Of Cros [print this page] The increased complexity of regulatory requirements and protocols, combined with access to a global patient population, makes clinical trial patient enrolment extremely difficult to manage effectively. We are going to look at what this means for pharmaceutical companies and the role CROs can play in patient enrolment.
The detriment of delays
The main problem of inefficient patient enrolment forecasting and management is costly delays. Any problems with enrolment completion can go on to affect approval submissions and eventually, the time it takes to get an asset to market. When a pharmaceutical company exceeds a budget or fails to get an asset to market within the predicted timeframe, it can incur huge costs to the tune of hundreds of millions of pounds.
Problems with patient enrolment account for 4.6 months worth of delays per trial. That totals around 26 months of annual cumulative delay. Translated into costs, a pharmaceutical company can lose approximately 5 billion a year.
This is brought into focus by the fact that only six percent of trials run to the project timeline and 72% or more of trials miss their completion date by over a month. Each day of delays affecting an asset getting to market can cost drug development companies 5 million.2
Clinical trial benchmarks and the role of CROs
DecisionView has recently launched a report on clinical trial enrolment benchmarks to assist pharmaceutical companies and CROs. CEO of DecisionView said: "There is tremendous demand for information that enables clinical trial executives and their teams to create more realistic enrolment plans, validate their assumptions and challenge their own organizations as well as their CRO partners in performing more optimally. Enrolment Benchmarks data further enriches the historical information they already have in StudyOptimizer and provides it right at the point of need - when they are making such critical, informed decisions."3
There is an upward trend in outsourcing to CROs when it comes to pharmaceutical companies making these informed decisions. Pharmaceutical companies need to ensure they select a CRO partner that has a long history of therapeutic excellence and a reputation for efficient patient enrolment. Selecting CRO partners with these attributes can greatly reduce the cost of getting a compound from the pipeline to peak sales.
