The State of Clinical Study Feasibility

Q1, 2012

Patient recruitment has been and will likely continue to be one of the most challenging steps in the clinical development process. Sponsors need to know how long it will take to bring a product to market, how much it will cost to get to approval, and if it is possible to recruit the necessary volume of patients in order to collect data with sufficient statistical power to meet regulatory requirements.

For this information they rely heavily on CROs and investigators who will, through the use of neglected databases and draft protocols with incomplete inclusion/exclusion criteria, promise the moon in an attempt to win business.

The quetsion we ask is: What good is a feasibility assessment that is not predictive of actual site and patient enrollment?

ISR would argue that the importance of these objectives warrants more energy being expended to tighten the bolts on a very loosely coupled process. This research was conducted to answer a few very specific questions:

• Is the state of feasibility in clinical trials different than it was when we addressed this topic in 2009?
• Are there any organizations doing it meaningfully better than others?  If so, who?  And what are they doing?
• How, if at all, has the industry embraced available technologies?
• How would sites and pharma personnel like to see feasibility change?

Download the free Report Preview to recieve sample report pages and a full table of contents.