TY - JOUR
T1 - Improving clinical trial accrual by streamlining the referral process
AU - Afrin, Lawrence B.
AU - Oates, James C.
AU - Kamen, Diane L.
N1 - Publisher Copyright:
© 2014 Elsevier Ireland Ltd.
PY - 2015/1/1
Y1 - 2015/1/1
N2 - Objective: Poor accrual rates impede clinical trial efficiency and significantly contribute to development costs for new interventions. Many providers recognize investigational treatments are their patients' best opportunities for improvement, but operational clinical burdens impede providers' awareness of, and ability to leverage, such opportunities. We aimed to develop a new workflow for non-intrusively apprising providers of trial opportunities for their patients and enabling providers to efficiently refer potential trial candidates to study teams for preliminary eligibility review. Materials and methods: We developed a small information system to monitor institutional systems, identify patients potentially eligible for ongoing clinical trials, and give providers a non-intrusive, one-click method to refer such patients to study teams for preliminary eligibility vetting. Results: In 18 months of pilot experience, providers invited study teams to vet 11% of 1844 patients found potentially eligible for 38 trials registered with the system. Seventy-nine patients were conservatively estimated to be accrued. Accrual rates were boosted for several trials. Results of a survey indicated most users were satisfied with the system. Discussion: Providers' time constraints impede their pursuit of investigational opportunities for their patients. In pilot experience, our novel approach to facilitating such pursuits yielded improved accrual, benefiting trials and presumably patients, too. Our approach may bear particular fruit for cross-disciplinary referrals for screening. Conclusion: Systems for assisting providers in making investigational opportunities available to their patients may benefit from careful attention to provider workflow and time constraints. Our system might further benefit from improved patient/trial matching and shorter messages.
AB - Objective: Poor accrual rates impede clinical trial efficiency and significantly contribute to development costs for new interventions. Many providers recognize investigational treatments are their patients' best opportunities for improvement, but operational clinical burdens impede providers' awareness of, and ability to leverage, such opportunities. We aimed to develop a new workflow for non-intrusively apprising providers of trial opportunities for their patients and enabling providers to efficiently refer potential trial candidates to study teams for preliminary eligibility review. Materials and methods: We developed a small information system to monitor institutional systems, identify patients potentially eligible for ongoing clinical trials, and give providers a non-intrusive, one-click method to refer such patients to study teams for preliminary eligibility vetting. Results: In 18 months of pilot experience, providers invited study teams to vet 11% of 1844 patients found potentially eligible for 38 trials registered with the system. Seventy-nine patients were conservatively estimated to be accrued. Accrual rates were boosted for several trials. Results of a survey indicated most users were satisfied with the system. Discussion: Providers' time constraints impede their pursuit of investigational opportunities for their patients. In pilot experience, our novel approach to facilitating such pursuits yielded improved accrual, benefiting trials and presumably patients, too. Our approach may bear particular fruit for cross-disciplinary referrals for screening. Conclusion: Systems for assisting providers in making investigational opportunities available to their patients may benefit from careful attention to provider workflow and time constraints. Our system might further benefit from improved patient/trial matching and shorter messages.
KW - Clinical research workflow
KW - Clinical trial accrual
KW - Clinical trial information systems
KW - Clinical trials
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U2 - 10.1016/j.ijmedinf.2014.09.001
DO - 10.1016/j.ijmedinf.2014.09.001
M3 - Article
C2 - 25256066
AN - SCOPUS:84914129358
SN - 1386-5056
VL - 84
SP - 15
EP - 23
JO - International Journal of Medical Informatics
JF - International Journal of Medical Informatics
IS - 1
ER -