TY - JOUR
T1 - Boosting enrolment in clinical trials
T2 - Validation of a regional network model
AU - Kernan, W.
AU - Viscoli, C.
AU - Brass, L.
AU - Amatangelo, M.
AU - Birch, A.
AU - Clark, W.
AU - Conwit, R.
AU - Furie, K.
AU - Gorman, M.
AU - Pesapane, B.
AU - Kleindorfer, D.
AU - Lovejoy, A.
AU - Osborne, J.
AU - Silliman, S.
AU - Zweifler, R.
AU - Horwitz, R.
N1 - Funding Information:
This work was supported by the National Institutes of Neurological Disorders and Stroke (NINDS) (U01 NS044876). Placebo and pioglitazone tablets were supplied by Takeda Pharmaceuticals North America, Inc. Acknowledgements
Funding Information:
We are not aware of a published taxonomy of trial networks but have proposed one in . Of the five listed models, the most well known is probably the ‘Managed Disease Community’ model as exemplified by the Cancer Clinical Trials Cooperative Groups funded by the U.S. National Cancer Institute (NCI) [ ]. The NCI funds ten regional groups each with a clinical coordinating centre (sometimes called an operations centre), a data centre, and personnel at participating cancer centres who are poised to enrol participants into trials. Trial concepts are usually developed by investigators within the group but approved and funded by the NCI. Unlike the outreach model, each cancer centre has its own in-house research team, including coordinators. The coordinating and data centres receive constant funding, but centre teams are funded primarily when they enrol a patient in a trial. Similar networks with federally funded infrastructures have been developed by other National Institutes of Health (NIH), including National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Neurological Disorders and Stroke (NINDS). The Neurological Emergencies Treatment Trial sponsored by the NINDS implements trials that emerge from investigators outside the NINDS and pass peer review [ ]. Unlike the NCI, NIAID, or NINDS Groups, the outreach model has no on-going financial support; as described in this article and used elsewhere, the outreach model is simply a tool to be used as a stand-alone network or within other trial networks.
PY - 2011/10
Y1 - 2011/10
N2 - Background Clinical trials of stroke therapy have been hampered by slow rates of enrolment.Purpose Our purpose is to validate a previously developed model for accelerating enrolment in clinical trials by replicating it at new locations. The model employs coordinators who travel from a host institution to enrol participants from a network of participating hospitals. Active surveillance assures identification of all eligible patients.Methods Among 70 U.S. investigators participating in National Institutes of Health-funded trial of stroke prevention, five investigators were invited to develop local identification and outreach networks (LIONs). Each LION comprised a LION coordinating centre servicing multiple hospitals. Hospitals provided names of patients with stroke or transient ischaemic attack to researchers at the LION coordinating centre who initiated contact; patients were offered home visits for consent and randomization. Outcomes were feasibility, enrolment, data quality, and cost.Results Five LIONs varied in size from two to eight hospitals. All 24 hospitals we approached agreed to participate. The average monthly rate of enrolment at the research sites increased from 1.4 participants to 3.5 after expanding from a single institution model to the LION format (mean change = 2.1, range 0.9-3.7). Monthly performance improved over time. Data quality was similar for LIONs and non-LION sites, except for drug adherence which was lower at LIONs. The average cost to randomize and follow one participant during the study interval was 2.4 times the cost under the per-patient, cost-reimbursement strategy at non-LION sites. The cost ratio declined from 3.4 in year one to 1.8 in year two.Limitations The LION strategy requires unprecedented collaboration and trust among institutions. Applicability beyond stroke requires confirmation.Conclusion LIONs are a practical, reproducible method to increase enrolment in trial research. Twelve months were required for the average site to reach its potential. The per-participant cost at LIONs was higher than conventional sites but declined over time.
AB - Background Clinical trials of stroke therapy have been hampered by slow rates of enrolment.Purpose Our purpose is to validate a previously developed model for accelerating enrolment in clinical trials by replicating it at new locations. The model employs coordinators who travel from a host institution to enrol participants from a network of participating hospitals. Active surveillance assures identification of all eligible patients.Methods Among 70 U.S. investigators participating in National Institutes of Health-funded trial of stroke prevention, five investigators were invited to develop local identification and outreach networks (LIONs). Each LION comprised a LION coordinating centre servicing multiple hospitals. Hospitals provided names of patients with stroke or transient ischaemic attack to researchers at the LION coordinating centre who initiated contact; patients were offered home visits for consent and randomization. Outcomes were feasibility, enrolment, data quality, and cost.Results Five LIONs varied in size from two to eight hospitals. All 24 hospitals we approached agreed to participate. The average monthly rate of enrolment at the research sites increased from 1.4 participants to 3.5 after expanding from a single institution model to the LION format (mean change = 2.1, range 0.9-3.7). Monthly performance improved over time. Data quality was similar for LIONs and non-LION sites, except for drug adherence which was lower at LIONs. The average cost to randomize and follow one participant during the study interval was 2.4 times the cost under the per-patient, cost-reimbursement strategy at non-LION sites. The cost ratio declined from 3.4 in year one to 1.8 in year two.Limitations The LION strategy requires unprecedented collaboration and trust among institutions. Applicability beyond stroke requires confirmation.Conclusion LIONs are a practical, reproducible method to increase enrolment in trial research. Twelve months were required for the average site to reach its potential. The per-participant cost at LIONs was higher than conventional sites but declined over time.
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U2 - 10.1177/1740774511414925
DO - 10.1177/1740774511414925
M3 - Article
C2 - 21824978
AN - SCOPUS:80054809784
SN - 1740-7745
VL - 8
SP - 645
EP - 653
JO - Clinical Trials
JF - Clinical Trials
IS - 5
ER -