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TABLE 1. Example performance metrics and benchmarks developed for the Palliative Care Research Cooperative Group (PCRC).
Structure – to be assessed for each site and whole PCRC
Ability of sites to use a centralized IRB for phase III and non-randomized trials
Goal: 90% since centralized IRB functions improve cooperative group efficiency but we don't want to restrict ourselves to only sites that make this allowance
Number of sites with experience in palliative care randomized controlled trials
Goal: 80%, since we have an objective to always be training some palliative care research naïve sites
Availability of a clinical research coordinator at the site experienced in palliative care research
Goal: 80%, since we have an objective to always be training some palliative care research naïve sites
Process
Assessment of the performance of the whole PCRC
Time from approval of study concept by the Scientific Review Committee to final version of the study protocol
Goal: 12 weeks
Time from identification of study-required TOP or SOP to finalization and distribution to study sites
Goal: 6 weeks
Time from identification of identification of the need to develop a CRF for a protocol to availability for use in the trial
Goal: 8 weeks
Time from final protocol to first IRB submission
Goal: 2 weeks
Proportion of site personnel with documentation of annual study-specific training
Goal: 100% (training is a SOP imperative)
Assessment of the performance of a specific PCRC study (note that summarizing these metrics contributes to assessment of overall cooperative group efficiency)
Time from IRB approval to first patient first visit at any site
Goal: 4 weeks
Time from IRB approval at a site to site training
Goal: 2 weeks
Time for an invoice to be paid when submitted from a site
Goal: 2 weeks
Time from data lock to analysis of main results available for manuscript development
Goal: 8 weeks
Time from availability of main results analysis to final manuscript ready for publication
Goal: 8 weeks
Assessment of the performance of a specific PCRC site (note that summarizing these metrics contributes to assessment of overall cooperative group and/or study efficiency)
Time from PCRC approval of a protocol for IRB submission at a site to site IRB approval
Goal: median 12 weeks
Time from IRB approval to first patient first visit at the site
Goal: 4 weeks
Outcomes
Assessment of the performance of the whole PCRC
Proportion of main study results published within 9 months of study completion
Goal: 75%
Number of research naïve sites added to PCRC each year
Goal: 5
Number of junior investigators supported through the PCRC each year (e.g., funding, access to data for pilot studies)
Goal: 5
Proportion of PCRC investigators participating in at least one face-to-face meeting each year
Goal: 80%
Proportion of annual reports submitted to PCRC sponsor(s) on time
Goal: 100%
Assessment of the performance of a specific PCRC study (note that summarizing these metrics contributes to assessment of overall cooperative group efficiency)
Proportion of accrual target achieved (benchmarked against a running accrual target for each month)
Goal: >80%
Proportion of CRFs entered into study database within 48 hours of data collection
Goal: 95%
Impact factor of journal where main results published
Goal: >10
Number of papers generated from study data
Goal: >5
Assessment of the performance of a specific PCRC site (note that summarizing these metrics contributes to assessment of overall cooperative group and/or study efficiency)
Proportion of accrual target achieved (benchmarked against a running accrual target for the site revised each month)
Goal: >80%
Proportion of CRFs entered into study database within 48 hours of data collection
Goal: 95%
Proportion of data elements entered generating queries for resolution
Goal: <0.05%
Proportion of allocated budget distributed to site