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Forward Looking Clinical Trials The Great Wall International Conference on Cardiology October 16 2014 Thach Nguyen, M.D FACC FSCAI St Mary Medical Center Hobart IN USA Outline Problems with traditional RCTs New forward looking CTs Randomized Clinical Trial    RCT is the best available technique for eliminating confounding factors in the assessment of a treatment effect With continued improvement in medical care, most treatment effects of interest in cardiovascular disease have only modest effects (RR reductions ~15-20%) Only RCTs can provide sufficient precision and confidence to reliably detect small benefits SMART OBSERVATION Limitations of RCTs    RCT’s are best suited to evaluation of “mature” therapies •Clinical trials are a poor way to evaluate rapidly changing technologies, particularly medical devices Trials are particularly vulnerable when enrollment is slow or the follow-up duration is long Comments on Methodology In a registry, all of the interventions stopped when the patients left the hospital, SMART OBSERVATION Limitations of RCTs  If the number of event too low, the patient population may be of too low risk Figure Cumulative coefficients obtained from the additive hazards model Giolo SR, Krieger JE, Mansur AJ, Pereira AC (2012) Survival Analysis of Patients with Heart Failure: Implications of Time-Varying Regression Effects in Modeling Mortality PLoS ONE 7(6): e37392 doi:10.1371/journal.pone.0037392 http://www.plosone.org/article/info:doi/10.1371/journal.pone.0037392 Criminals and Fugitives Identified by Robotcop Glasses Hidden Adversaries Located by Scanners A whole hospitalization course, cost, date of discharge could be generated when the patient checks in Asymptomatic patients could be scanned for future relapses and so the problems can be treated early or prevented CONCLUSIONS ESC Draft of New Guidelines The new draft guidance, on the basis of the EXCELLENT and PRODIGY studies, recommend a reduced duration of DAT after DES: six months, instead of to 12 The draft guidelines also specify, however, that "more than six months" is preferable in patients at high ischemic risk and low bleeding risk Figure Cumulative coefficients obtained from the additive hazards model Giolo SR, Krieger JE, Mansur AJ, Pereira AC (2012) Survival Analysis of Patients with Heart Failure: Implications of Time-Varying Regression Effects in Modeling Mortality PLoS ONE 7(6): e37392 doi:10.1371/journal.pone.0037392 http://www.plosone.org/article/info:doi/10.1371/journal.pone.0037392 Criminals and Fugitives Identified by Robotcop Glasses Hidden Adversaries Located by Scanners A whole hospitalization course, cost, date of discharge could be generated when the patient checks in Asymptomatic patients could be scanned for future relapses and so the problems can be treated early or prevented