SOURCE: Cutting Edge Information

Cutting Edge Information

September 22, 2015 09:00 ET

Life Sciences Companies: Implement Risk-Based Monitoring Approaches During Longer Clinical Trials to Maximize Financial Impact

RESEARCH TRIANGLE PARK, NC--(Marketwired - September 22, 2015) - For many life science companies, risk-based monitoring (RBM) is an effective cost-reduction technique for clinical trials. Whereas on-site monitoring is a significant expense that can equal up to 60% of overall clinical trial costs, RBM strategies allow a smaller team of monitors to handle communication with sites remotely and to review only a percentage of incoming data for accuracy. In addition to maximizing personnel and time resources, these strategies can also minimize financial expenditures, especially during longer clinical trials, according to primary intelligence provider Cutting Edge Information.

However, although RBM trials can be more cost-effective than traditional trials, it is important to note that not every RBM study will cut spending. The clinical development phase, as well as the study duration and number of clinical sites, impact overall RBM costs. An executive at a Top 50 life sciences company explained that RBM trials still include a number of on-site visits for many companies. At this executive's organization, teams conduct the initial site visit -- as well as the first one or two monitoring visits - in person before transitioning to remote or reduced frequency monitoring. The company also performs periodic on-site monitoring visits -- typically once per six months -- and an on-site final monitoring visit. This strategy allows the company to ensure high levels of data accuracy and site efficiency.

"Similar RBM strategies may only reduce on-site monitoring visits by one or two instances in shorter trials, thereby limiting monitoring-related savings. However clinical teams can significantly reduce the number of on-site visits and increase the number of sites per monitor during longer studies," said Sarah Ray, senior research analyst at Cutting Edge Information.

Overall, surveyed companies report the greatest savings during Phases 3 and 4 -- at an average 21% and 22% total savings, respectively. These data are significantly impacted by an outlier, a device company reporting 80% total savings during Phases 1 and 4 -- the highest percentage saved by any company in any development phase. This company's reported savings influence the small and device company average as well as the overall average. Surveyed CROs report similar savings during Phases 3 and 4, following the overall trend. These companies average 21% and 23% savings, respectively.

"Risk-Based Monitoring: Inject Remote Risk Assessment to Optimize Clinical Trial Outcomes" by Cutting Edge Information provides benchmarks on budgets and staffing for risk assessment teams and RBM activities. The report also includes best practices for implementing RBM strategy and tactics associated with risk-based monitoring usage. The report segments companies' existing use of risk-based monitoring strategy by therapy and trial phase to showcase RBM's role in efficient clinical trial management.

The study will help clinical operations executives:

  • Avoid implementing overly complicated RBM techniques
  • Balance existing budget and staffing resources
  • Map out clinical strategy well before trial initialization

To learn more about Cutting Edge Information's research report offerings and CEIConnect subscription services, please visit http://cuttingedgeinfo.com/.

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