TY - JOUR
T1 - Improving efficiency and reducing costs
T2 - Design of an adaptive, seamless, and enriched pragmatic efficacy trial of an online asthma management program
AU - Lu, Mei
AU - Ownby, Dennis R.
AU - Zoratti, Edward
AU - Roblin, Douglas
AU - Johnson, Dayna
AU - Johnson, Christine Cole
AU - Joseph, Christine L.M.
N1 - Funding Information:
This work was supported by the National Institutes of Health (NIH) NCI Grant R01HL114981.
PY - 2014/5
Y1 - 2014/5
N2 - Clinical trials are critical for medical decision-making, however, under the current paradigm, clinical trials are fraught with problems including low enrollment and high cost. Promising alternatives to increase trial efficiency and reduce costs include the use of (1) electronic initiatives that permit electronic remote data capture (EDC) for direct data collection at a site (2), electronic medical records (EMR) for patient identification and data collection, and (3) adaptive, enrichment designs with pragmatic approaches. We describe the design of a seamless, multi-site randomized Phase II/III trial to evaluate an asthma management intervention in urban adolescents with asthma. Patients are randomized, asked to access four online sessions of the intervention or control asthma management program, and are then followed for one year. The primary efficacy endpoint is self-reported asthma control as measured by the Asthma Control Test (ACT). Comparative effectiveness parametric approaches are utilized to conduct the trial in a real world setting with reduced costs. Escalated electronic initiatives are implemented for patient identification, assent, enrollment and tracking. Patient enrollment takes place during primary care visits. A centralized database with EDC is used for CRF data collection with integration of EMR data. This Phase II/III trial plans to have a total sample size of 500 patients with an interim look at the completion of Phase II (n = 250), The interim analyses include an assessment of the intervention effect, marker(s) identification and the feasibility study of EMR data as the trial CRF data collection. Patient enrollment has begun and is ongoing.
AB - Clinical trials are critical for medical decision-making, however, under the current paradigm, clinical trials are fraught with problems including low enrollment and high cost. Promising alternatives to increase trial efficiency and reduce costs include the use of (1) electronic initiatives that permit electronic remote data capture (EDC) for direct data collection at a site (2), electronic medical records (EMR) for patient identification and data collection, and (3) adaptive, enrichment designs with pragmatic approaches. We describe the design of a seamless, multi-site randomized Phase II/III trial to evaluate an asthma management intervention in urban adolescents with asthma. Patients are randomized, asked to access four online sessions of the intervention or control asthma management program, and are then followed for one year. The primary efficacy endpoint is self-reported asthma control as measured by the Asthma Control Test (ACT). Comparative effectiveness parametric approaches are utilized to conduct the trial in a real world setting with reduced costs. Escalated electronic initiatives are implemented for patient identification, assent, enrollment and tracking. Patient enrollment takes place during primary care visits. A centralized database with EDC is used for CRF data collection with integration of EMR data. This Phase II/III trial plans to have a total sample size of 500 patients with an interim look at the completion of Phase II (n = 250), The interim analyses include an assessment of the intervention effect, marker(s) identification and the feasibility study of EMR data as the trial CRF data collection. Patient enrollment has begun and is ongoing.
KW - Adolescents
KW - Asthma management intervention
KW - Clinical trials
KW - Comparative effectiveness research
KW - Enrichment design
KW - Seamless adaptive design
UR - http://www.scopus.com/inward/record.url?scp=84897827544&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84897827544&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2014.02.008
DO - 10.1016/j.cct.2014.02.008
M3 - Article
C2 - 24607295
AN - SCOPUS:84897827544
SN - 1551-7144
VL - 38
SP - 19
EP - 27
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
IS - 1
ER -