Not all issues that site staff complain about influence study success. In this note I’m going to discuss five common complaints that, based on our database from more than 400 sites, are not determinants to study success.
These issues are important because they will be heard frequently by your team, CRAs and MSLs. They are common. Yet, based on our data, they are less likely than many other issues to influence the ultimate number of patients randomized in trials.
1. Protocol-related tasks require more site staff time than budgeted
The most commonly identified issue among all of the studies we evaluated was that protocol-related tasks require more staff time than budgeted. According to our data, 44% of unsuccessful sites (i.e., sites which randomized less than 75% of the number of patients targeted during feasibility) complained that protocol-related tasks required more staff time than budgeted. This is an issue that you, your CRAs and MSLs are likely to hear from sites.
Unfortunately, the same percent (44%) of successful sites complained about this same issue. There is no difference in the percent of successful vs unsuccessful sites which have an issue with protocol-related tasks requiring more staff time than budgeted.
2. Delayed payments to site
The second most commonly identified issue among all studies was that payments to site were delayed. 38% of unsuccessful site staff said that payments to their site were delayed. Unfortunately, 37% of successful site staff had the same complaint, a non-significant difference of 1%!
There is no excuse for pharma companies taking months to pay their bills. However, delayed payments is unlikely to be a major cause of trials being unsuccessful.
3. CRA personnel request same documents multiple times
You probably hear site staff complain that they are required to submit the same documents multiple times. It is true. 33% of site staff for unsuccessful trials identify this as an issue. It is also true that 30% of site staff for successful trials complain of the same issue.
4. Patients perceive length of visits as too long
Patient visits are frequently too long. Prolonged visits require some patients and/or caregivers to miss work. Patients who travel significant distances to sites have to rise early and sometimes stay overnight at a nearby hotel.
However, for both successful and unsuccessful studies, 24% of site staff complain that patients perceive the length of visits to be too long.
5. Too few patients are referred from other physicians
The fifth frequent complaint that does not discriminate between successful and unsuccessful studies is that too few patients are referred from HCPs. 26% and 23% of unsuccessful and successful studies identify insufficient HCP referrals as an issue, respectively.
For more information on how you can accelerate your trials, contact me.
Ross H. Weaver, PharmD, MBA