Growing acknowledgment of the integral role that clinical research associates (CRAs) play in ensuring clinical trial success combined with rising concerns about the unprecedented demands placed on CRA workload have prompted regulatory agencies, sponsors and CROs to explore new approaches to reduce that workload including risk-based study monitoring.
Despite intensifying attention on the CRA landscape, little empirical data exists on study monitor workload and utilization. In response, Tufts Center for the Study of Drug Development (Tufts CSDD) conducted a study to gather baseline metrics quantifying CRA responsibilities and summarizing how their time is utilized. The results of this study offer insights into how CRA time is allocated and workload is apportioned, and assist managers in measuring the impact of new reforms designed to improve CRA effectiveness and efficiency.
Capturing Baseline Data
Tufts CSDD convened a group of 18 mid-sized and major pharmaceutical and biotechnology companies and contract research organizations (CROs) to participate in the study. Participants worked collaboratively with Tufts CSDD to develop an online survey instrument delivered globally. The online survey instrument provided detailed definitions of CRA responsibilities including: On-site monitoring activities; off-site monitoring activities; administrative activities; training activities; and travel-related activities. Detailed definitions of workload measures and time allocation categories were also provided in the online survey.
Workload was measured on a per month basis across several dimensions including the number of protocols maintained; number of planned and actively monitored investigative sites; the number of active study subjects under CRA oversight and the number of site monitoring visits. CRA utilization was measured in hours per month.
Tufts CSDD received 3,970 completed online surveys representing a 36% response rate. Seven out of ten respondents (2,763) were CRAs employed by contract research organizations, 26% (1,030) of respondents were employed by pharmaceutical and biotechnology companies and staffing agencies employed 4% of respondents.
Ninety-four percent of respondents were employed as full-time study monitors overseeing clinical trials across a broad and representative range of therapeutic areas. Nearly half was involved with oncology and cardiovascular clinical trials – 55% and 47% respectively; one-third was involved with CNS (33%) and endocrine trials (30%); Approximately one-out-of-four respondents oversaw infectious disease (27%) and respiratory (26%) trials.
Four-out-of-ten respondents were based in Europe; 35% in North America; 14% in Asia/Pacific, 9% in Latin America and 2% in the rest of the world. Respondents overall have worked as CRAs for an average of 6.3 years.
The majority of respondents (83%) monitor phase II and III studies and for the remainder of this article, we’ll focus on CRA workload and utilization in these phases.
8 visits per month and 62 Patients
The average reported workload per month for CRAs monitoring phase II and III studies was 3.5 protocols in the maintenance phase; 5.8 planned and 8.9 activated investigative sites; and 61.9 active study volunteers. CRAs conducted 7.9 site monitoring visits on average each month.
Regional workload differences were observed. CRAs based in Latin America conducted a high average number of site monitoring visits per month and oversaw the highest average number of active study subjects. Study monitors in Canada performed the highest average number of site monitoring visits and oversaw the highest average number of protocols per month. US and Western European CRAs monitored a relatively high average number of activated sites. CRAs in the US also monitored a relatively high average number of protocols.
CRAs in Asia/Pacific had significantly lower workload across all dimensions. These study monitors also had lower average numbers of activated sites, and monitoring visits.
42-Hour Work Week
Overall, CRAs spend a total of 165 hours each month-or 42 hours a week-managing all of their responsibilities. Four out of every ten hours (41%) re spent on-site conducting monitoring visits. Approximately 22% of total CRA time – 36 hours on average per month – is spent on off-site monitoring activities. Eighteen percent of total CRA time is spent traveling to meetings and monitoring visits. Administrative tasks and training make up the remaining 19% of total CRA time at 22 and 9 hours respectively.
CRAs employed by pharmaceutical and biotechnology companies work an average of 14 hours more per month than do those employed by CROs. Sponsor company CRAs spend more time conducting on-site monitoring visits, off-site monitoring activities and on administrative tasks each month. Contract service provider CRAs spend more time traveling to and from investigative sites each month.
There were wide variations in time utilization by geographic region. North American-based CRAs spend the highest average total time each month performing their responsibilities. US-based CRAs spend an average of 178 hours each month; and Canadian CRAs spend 171 hours on average each month.
American and Canadian CRAs spend the highest amount of time conducting on-site monitoring visits every month. US-based CRAs also spend the most time traveling. Whereas CRAs outside the US reported that more than half of their site-monitoring visits were to local locations. Only 27% of US-based CRA travel is local – the majority of their time (73%) is to remote locations.
Asia/Pacific CRAs spend significantly fewer hours performing on site monitoring visits than do their North American colleagues. CRAs based in Latin America spend significantly more time than their North American counterparts on administrative tasks. Latin American and Asia/Pacific study monitors spend significantly more time each month on professional development and training.
Looking more closely at time utilization, it is evident that CRAs in less mature regions take on many responsibilities that are eventually handled by support functions in more mature regions. Sponsors and CROs often require their CRAs in less mature regions to translate contracts and budgets into local languages and to negotiate these agreements and budgets. In North America, dedicated teams typically handle these duties. CRAs in less mature markets must dedicate some of their time to review confidentiality agreements and feasibility questionnaires.
CRAs in Western and Eastern Europe spend the least amount of total time per month performing their responsibilities. Western European CRAs spend 45% fewer average hours traveling than do their US-based peers.
Base Case Workload and Utilization
Is 40% of CRA time spent at the investigative site sufficient to nurture an effective relationship and engage study staff? Is 8 visits, 4 active protocols and 62 study participants per month adequate use of CRA capacity? The results of this study cannot answer these questions though the results will serve as important baseline measures in the future.
Tufts CSDD plans to conduct future research on trends in CRA time allocation and on the impact of reduced in-person monitoring time and risk-based monitoring approaches on investigative site performance and morale. Additional research is also needed to determine if study monitors are handling too many responsibilities and devoting adequate time to their investigative site relationships.
There is no question that CRA roles and responsibilities will evolve substantially over the next several years due to a variety of factors including the advent of new technology solutions (e.g., electronic health records), changing global operating environment and infrastructure for conducting clinical trials, and organizational and regulatory pressures to adopt risk-based monitoring approaches. Pharmaceutical, biotechnology and CRO companies also face unrelenting pressure to lower clinical development costs and improve efficiency. The results of this Tufts CSDD study set baseline metrics from which trends and newly implemented practices can be evaluated and refined.
The article originally appeared in the CLINICAL TRIALS YEARBOOK 2013 Published By ARENA INTERNATIONAL EVENTS GROUP.