The growing disparity between clinical trial complexity and investigator compensation

The issue of investigator compensation in clinical trials is a contentious one, with opinions varying widely between academic researchers, clinical trialists and pharmaceutical companies. Many academic researchers maintain that clinical trial budgets are excessive. Clinical trialists are usually of the opinion that the study budgets are inadequate considering the many potential safety issues, the continuous monitoring of patients and the many 'hidden costs' involved in clinical trials. Pharmaceutical companies and clinical research organisations (CROs) are invariably of the opinion that their study budgets are appropriate. The Tufts Centre for the Study of Drug Development (CSDD) recently conducted a study that examined the impact of protocol design on clinical trial performance. The results indicate that the median number of procedures per clinical trial increased by 49% from 2000–2003 to 2004–2007, while the total effort required to complete these procedures grew by 54%. 1 According to the author, 'more complex and burdensome protocols are extending study cycle times, increasing costs and challenging patient recruitment and retention'. 1 In addition, the rise in the number of eligibility criteria used to screen volunteers has negatively affected the number of volunteers enrolling in clinical trials. This study also found a wide variability in the complexity between therapeutic areas and clinical study phases. Overall, growth in complexity grew at the slowest rate for phase III protocols as companies begin to gather more data in the early phases of clinical research in an attempt to minimise costs. 1 There have been growing concerns among investigators regarding grant amounts and the slow payment process. 2 A review of more than 52 000 study contracts from the CSDD showed that grant size has remained relatively constant since 1998, while the number of procedures per protocol has risen drastically. 2 In addition, the average dollars paid per procedure per patient has declined by 27% over that same period. 2 This review also reported that it takes pharmaceutical companies on average 140 business days to pay an investigator for work performed. 2 retrospective analysis We conducted a study to investigate firstly, the average payment per patient per visit at our site, and secondly, to determine the time taken from date of the patient's visit to date of site payment for CROs and for pharmaceutical companies. The study was conducted by TREAD Research, a site-managed organisation (SMO) based at Tygerberg Hospital, Parow, Western Cape, South Africa. Random clinical trial agreement (CTA) budgets …