The randomized registry trial--the next disruptive technology in clinical research?
نویسندگان
چکیده
1. Zarin DA. Participant-level data and the new frontier in trial transparency. N Engl J Med 2013;369:468-9. 2. European Medicines Agency. Publication and access to clinical-trial data: draft policy 0070. June 24, 2013 (http://www.ema.europa .eu/docs/en_GB/document_library/Other/ 2013/06/WC500144730.pdf). 3. Pharmaceutical Research and Manufacturers of America, European Federation of Pharmaceutical Industries and Associations. Principles for responsible clinical trial data sharing (http://phrma.org/sites/default/files/ pdf/PhRMAPrinciplesForResponsibleClinical TrialDataSharing.pdf). 4. Rabinowitz J, Werbeloff N, Stauffer V, Mandel F, Kapur S. More efficient drug discovery trials in schizophrenia: insights from 29 placebo-controlled randomised controlled trials (RCTs) from the NEWMEDS repository. Presented at the 24th Congress of the European College of Neuropsychopharmacology, Paris, September 3–7, 2011 (http://conference services.elsevier.nl/11ecnp/index.cfm?fuse action=CIS2002&hoofdnav=Search&content =zk.results_all&topicselected=*&searchtext =rabinowitz&what=FREE%20TEXT&selection =ALL&abstrnbr=S.11.03). 5. Catalyzing the transformation of healthcare innovation: a working paper from the MIT Center for Biomedical Innovation. Cambridge: Massachusetts Institute of Technology, January 2010 (http://cbi.mit.edu/ wp-content/uploads/2011/04/MIT-NewDigs -White-Paper-20100118.pdf).
منابع مشابه
Effects of dairy Products on Fasting Blood Glucose, Insulin Resistance, Blood Pressure, and Lipid Profile in Patients with Type 2 Diabetes: A Randomized, Controlled Clinical Trial
Introduction: This randomized controlled clinical trial aimed to investigate the effects of dairy product consumption on fasting blood glucose, insulin resistance, blood pressure, and lipid profile in patients with type 2 diabetes. Materials and Methods: Ninety-one diabetic patients were randomly assigned to one of the following three groups: group A, <1 serving of dairy products per day; group...
متن کاملEffect of Leventhal’s Self-Regulatory Model on Illness Perception in Women with Gestational Diabetes: A Randomized Controlled Clinical Trial
Background and purpose: Illness perception can affect self-care, mental anxiety, and other health outcomes in individuals. Current study aimed to investigate the effect of Leventhal’s Self-Regulatory Model on illness perception in women with Gestational Diabetes Mellitus (GDM). Materials and methods: A randomized controlled clinical trial was performed in women with GDM admitted to prenatal d...
متن کاملComparison of percutaneous versus open surgical techniques for placement of peritoneal dialysis catheter in children: A randomized clinical trial
Background: This research compares the outcomes of percutaneous technique and open surgical peritoneal dialysis catheter placement in children. Methods: In this randomized controlled trial, between 2010 and 2011,a total of 35 pediatric uremic patients were enrolled and randomized into two study groups. Follow up data included duration of operation (minute), duration of hospitalization (days...
متن کاملCarcinoid heart disease.
comes and angiotensin converting enzyme inhibitor effects in patients with predominantly left ventricular dysfunction and heart failure. Eur J Heart Fail 2014;16:325–333. 24. Eklind-Cervenka M, Benson L, Dahlstrom U, Edner M, Rosenqvist M, Lund LH. Association of candesartan vs. losartan with all-cause mortality in patients with heart failure. JAMA 2011;305:175–182. 25. Lauer MS, D’Agostino RB ...
متن کاملEfficacy of a Gel from the Seed of Trigonella foenum-graceum L. in Preventing Trichoptilosis: A Randomized Placebo-Controlled Clinical Trial
Background and purpose: Trichoptilosis with fragility and hair loss is a common disorder, but, still there is no specific and effective treatment for this condition. The aim of this study was to evaluate the efficacy of gel from the seed of Trigonella foenum-graceum L. in prevention of trichoptilosis in people with trichoptilosis. Materials and methods: A double-blind placebo controlled clini...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- The New England journal of medicine
دوره 369 17 شماره
صفحات -
تاریخ انتشار 2013