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. 2022 Oct 4;44(1):110–120. doi: 10.1093/epirev/mxac009

Table 2.

Summary of Early-Terminated Publications

First Author, Year (Reference No.) CSP Study No. Publication Title Clinicaltrials.Gov National Clinical Trial No. Condition or Disease Intervention Primary Outcome Actual No. Expected No. Primary Reason for Early Termination Secondary Reason For Early Termination Sponsor
Lin, 2020 (6) 553 Chemotherapy after prostatectomy for high-risk prostate carcinoma: a phase III randomized study NCT00132301 Prostate cancer Docetaxel plus prednisone vs. standard of care Progression-free survival 298 636 Enrollment CSP; Sanofi
Kamalesh, 2013 (7) 557 Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes NCT00326196 Coronary artery disease PCI vs. CABG Death or nonfatal MI 198 790 Enrollment CSP
Brilakis, 2018 (8) 571 Drug-eluting stents versus bare-metal stents in saphenous vein grafts: a double-blind, randomized trial NCT01121224 Saphenous vein graft atherosclerosis BMS vs. DES Death, MI, or revascularization 597 762 Enrollment Funding CSP
Rosenheck, 2011 (9) 555 Long-acting risperidone and oral antipsychotics in unstable schizophrenia NCT00132314 Schizophrenia/schizoaffective disorder IM risperidone vs. oral antipsychotic Time to hospitalization 369 450 Enrollment Clinical practice CSP
Lo, 2010 (10) 558 Robot-assisted therapy for long-term upper-limb impairment after stroke NCT00372411 Stroke Robot-assisted therapy vs. intensive therapy vs. standard of care Fugl-Meyer Assessment for Motor Recovery scale 127 158 Enrollment Futility CSP; Burke Medical Research Institute
Bauman, 2013 (11) 535 The effect of oxandrolone on the healing of chronic pressure ulcers in persons with spinal cord injury a randomized trial NCT00101361 Pressure ulcer Oxandrolone vs. placebo Time to full healing 212 400 Futility CSP
McFall, 2010 (12) 519 Integrating tobacco cessation into mental health care for posttraumatic stress disorder: a randomized controlled trial NCT00118534 Mental health, PTSD, tobacco use disorder Integrated care for smoking cessation vs. standard of care Prolonged abstinence 943 1,400 Benefit CSP
O’Dell, 2013 (13) 551 Therapies for active rheumatoid arthritis after methotrexate failure NCT00405275 Rheumatoid arthritis Etanercept vs. placebo Change in disease activity score for 28 joints 353 450 Funding CSP
Fried, 2013 (14) 565 Combined angiotensin inhibition for the treatment of diabetic nephropathy NCT00555217 Kidney disease, type 2 diabetes Losartan monotherapy vs. losartan plus lisinopril Rate of glomerular filtration rate decline, development of end-stage renal disease, and death 1,448 1,850 Safety CSP
Fan, 2012 (15) 560 A comprehensive care management program to prevent chronic obstructive pulmonary disease hospitalizations: a randomized, controlled trial NCT02036294 COPD COPD self-management education vs. standard of care Time to first hospitalization for COPD 426 960 Safety CSP
Holodniy, 2011 (16) 512 Results of antiretroviral treatment interruption and intensification in advanced multi-drug resistant HIV infection from the OPTIMA Trial NCT00050089 HIV infection No ARDFP vs. ARDFP; standard ART vs. mega-ART (5 or more anti-HIV drugs) New or recurrent AIDS or death 368 390 Clinical practice CSP; MRC; CIHR

Abbreviations: AIDS, acquired immunodeficiency syndrome; ARDFP, antiretroviral drug–free period; ART, antiretroviral therapy; BMS, bare-metal stent; CABG, coronary artery bypass grafting; CIHR, Canadian Institutes of Health Research; COPD, chronic obstructive pulmonary disease; CSP, Cooperative Studies Program Study; DES, drug-eluting stent; HIV, human immunodeficiency virus; IM, intramuscular; MI, myocardial infarction; MRC, Medical Research Council; PCI, percutaneous coronary infusion; PTSD, post-traumatic stress disorder; VA, Veterans Affairs.