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Re: oneragman post# 90177

Saturday, 08/27/2016 11:47:24 AM

Saturday, August 27, 2016 11:47:24 AM

Post# of 429206
P - Your post may be just your usual "turd in the punchbowl" comments. However, I do feel I have to respond. Your post stating <5% probability of success at ANY time point are as unjustified as those claiming 100% likely stop at first interim. This is a multiyear study costing more $100 million, and a company does not invest that much money on a <5% chance of positive findings. Company management stand to make a lot of money on their stock if PPS increases so obviously the have a vested interest in designing R-IT to succeed if possible. The company employs scientist consultants with expertise in this area when designing the study. The scientists involved in developing the study design are competent (PI is at Harvard and they do not give out faculty positions easily). There are just as many, or more, studies by numerous researchers highlighting multiple beneficial effects of EPA than there are studies suggesting there is no effect such as those you repeatedly cite. The R-IT sample size of more than 8000 patients was chosen based on conservative effect sizes derived from those actually observed in the most similar previous studies, the desired level of power to detect an effect if there was one (90%), and their willingness to have an erroneous positive finding (e.g., p<.05 = 5%). They have also enriched the study for sicker people most likely to benefit both from direct TG-related and antiinflammatory-related effects of EPA, with an increase in "disease severity" as time went on. This increases the odds of significant effects. None of us can predict what the actual findings will be, but the likelihood of success is certainly >50% at the 2nd IA and final analysis, if not before, and may be substantially higher odds than this.
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