This is a follow-up to last week’s email about academic sites. This week I focus on non-academic practice sites.
What affects patient recruitment and enrollment for them?
Recently, we conducted a survey among non-academic site staff to identify the issues they encounter frequently during clinical trials. More than 120 site staff completed the survey; of those, 52% were sites that enrolled 75% or more of the targeted number of respondents.
The most common issues among non-academic practice sites were:
- Excessive turnover among CRAs/monitors (50% of all non-academic practice sites)
- There were an excessive number of queries from study-related software vendors (44%)
- Protocol-related tasks require more staff time than budgeted (43%)
- Data entry is excessively repetitive (43%)
- Payments to sites are delayed (42%)
We also compared the frequency of issues encountered by sites which were ‘successful’ in patient enrollment (i.e., 75%+ targeted enrollment) with ‘unsuccessful’ sites (less than 75% targeted enrollment). Five attributes with the biggest separation between successful and unsuccessful sites were:
- Site initiation visits are too general (identified by 11% of successful versus 41% of unsuccessful sites)
- Central laboratory results are inconsistent with local laboratories (8% vs 34%)
- Software ‘crashed’ too frequently (14% vs 39%)
- Sponsor was too pushy about enrollment (6% vs 31%)
- Site staff was inadequate training on hardware (0% vs 25%)
What is striking to me about this list is, once again, that none of the top five issues were related to eligibility criteria. Software/hardware issues were far more common issues. The takeaway message? Eligibility requirements may hinder site participation. They are not the major barriers for site engagement.
When on-time delivery of your clinical trial is critical, contact me. We can ensure your trials deliver on time.
Ross H. Weaver, PharmD, MBA