What affects patient recruitment and enrollment? At the site level, which issues are important depends on the type of site. Academic sites are frequently larger with more infrastructure than many private practices. Their issues differ from private practice or dedicated research sites.
Recently, we conducted a survey among academic site staff to identify the issues they encounter frequently during clinical trials. More than 100 site staff completed the survey; of those, 53% were sites that enrolled 75% or more of the targeted number of respondents.
The most common issues among academic sites were:
- Protocol-related tasks required more staff time than budgeted (51% of respondents)
- There were an excessive number of queries from study-related software vendor (47%)
- Amendment-related tasks required more staff time than budgeted (45%)
- There were too many passwords to remember (45%)
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). Three attributes with the biggest separation between successful and unsuccessful sites were:
- Too much turnover of CRA staff (22% of successful sites vs 61% of unsuccessful sites)
- Amendment-related tasks required more staff time than budgeted (27% vs 65%)
- CRA lacked knowledge of the protocol (16% vs 45%)
What is striking to me about this list is that none of the top four issues were related to eligibility criteria. In fact, no protocol-related issues were selected by more than 30% of respondents.
The takeaway message? Focus on relationships. As I commonly quote, they want to know you care before they care what you know.
When on-time delivery of your clinical trial is critical, contact me. We can ensure your trials deliver on time.
Ross H. Weaver, PharmD, MBACo-Founder Clinical SCORE Phone: 610-256-5623 Email: firstname.lastname@example.org www.clinical-score.com