Clinical Trials-Related Administrative Workload and the Methods Used to Assess It
Woodroffe, Annette A.
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The 2012 Faculty Research Survey Research Report conducted by the Federal Demonstration Partnership (Survey) found that clinical trials were one of the 22 most common administrative workload burden activity areas. This Project was launched from that finding and makes the case for a greater recognition of clinical trials as a clinical research subspecialty impacted by clinical trials-related workload problems. The clinical trials findings from the Survey were compared to available measurement tools on workload and clinical trials to determine whether the same and/or other workload administrative variables would be found. The researcher found that each measurement tool contained some of the variables that had been identified in the Survey. Those variables that were identified in the Survey and other measurement tools included: 1) Difficulty negotiating acceptable protocol; 2) Redundancy in reporting data; 3) Concerns about informed consent; 4) Working with boards such as the Institutional Review Board for the Protection of Human Subjects (IRB); 5) The requirement to post and update trials results; 6) The requirement to post and update trials progress; and 7) The degree of coordination required in managing clinical trials. Yet there were variables in the measurement tools that were not found in the Survey. For example, a single module in one of the measurement tools covered distinct workload activities pertaining to informed consent that included: more information on face to face contacts with patients and more telephone contacts to clarify trial participation, and also documented continuous psychological support to the subjects. None of the measurement tools captured the frustrations in the Survey that salaries were not keeping pace with the cost of living, and reporting requirements were not being uniformly enforced. In conclusion, the measurement tools other than the Survey were designed specifically to measure clinical trials workload and included an analysis that intentionally focused on multifaceted dimensions of workload. This focus specifically on clinical trials resulted in a more comprehensive examination of clinical trials workload. In an analysis of other measurement tools compared to the survey results, the researcher uncovered numerous areas that had not been addressed by the Survey. Furthermore, the measurement tools were not only designed to measure the workload burdens of the principal investigator, but those of the team who worked in clinical trials, thus allowing for a more comprehensive understanding of workload and administrative workload. The findings support the need identified by the Project.