As industry leaders, Clinical SCORE’s mission is to help clients be more successful by identifying and addressing factors which are, or will, hinder completion of their trials. We continue to innovate by exploring different aspects which affect timely completion of trials.
For example, we have evaluated factors by geographic regions of the world, and also by therapeutic areas. In this email, I will evaluate factors hindering clinical trials by types of sites. I’ve grouped sites into four categories:
- Dedicated research
- Small clinic sites
- Large clinic sites
We evaluated factors that determine whether each type of site is able to randomize their targeted number of patients. There are some common factors for all types of sites and some factors which are distinct to specific categories of sites.
Universally Common Factors: Software and protocol-related issues significantly influence the success of all four types of sites. As I have mentioned in earlier emails, software-related issues have the biggest impact on site success or failure. We just completed an oncology study for which each site had a median of 30 active trials.
Assuming four software programs per trial, this equates to 120 software programs!
The most common protocol-related issue is…eligibility criteria. This is hardly a surprise. Many studies have shown studies have become increasingly complex with more and more eligibility criteria being required.
Moderately Common Factors: Training-related issues have a significant influence on academic and small clinic sites. Training and reference documents are important to academic sites because of the numerous ongoing trials and the size of the typical research settings. Small clinic sites frequently have less experienced staff and rely on training more than large clinic sites or dedicated research sites.
Recruitment support have a significant influence on dedicated research and small clinic practices. Both rely on external patient recruitment more than the other types of sites.
Issues distinct to specific types of sites: Compensation and CRA/Monitor personnel issues have significant influences only on small clinic sites. Consistency between central and local laboratories has a significant influence only on dedicated research sites. Excessive “pushing” to enroll patients is an issue only for academic sites.