What is a clinical trial protocol?
نویسندگان
چکیده
Trial protocols are documents that describe the objectives, design, methodology, statistical considerations and aspects related to the organization of clinical trials. Trial protocols provide the background and rationale for conducting a study, highlighting specific research questions that are addressed, and taking into consideration ethical issues. Trial protocols must meet a standard that adheres to the principles of Good Clinical Practice, and are used to obtain ethics approval by local Ethics Committees or Institutional Review Boards.
منابع مشابه
P-149: GnRH Antagonist versus Agonist in Normoresponders Undergoing ICSI: A Randomized Clinical Trial in Iran
Background: General concern is that the pregnancy rate is higher with GnRH-agonist as a protocol of pituitary suppression. GnRH-antagonist protocol provides a shorter period of administration and an easy flexible protocol. In this study, the outcomes of GnRH agonist and antagonist in ICSI cycles are compared in normo responder patients. Materials and Methods: In this randomized clinical trial, ...
متن کاملFlexible Multi-dose GnRH Antagonist versus Long GnRH Agonist Protocol in Poor Responders: A Randomized Controlled Trial
Background To compare a flexible, multi-dose GnRH antagonist protocol with a long GnRH .agonist protocol in poor respo MaterialsAndMethods A randomized clinical trial of 70 poor responder patients (35 patients in GnRH antagonist protocol and 35 patients in long GnRH agonist protocol) was performed at Royan Institute, Tehran, Iran. Both groups were given a fixed dose of human menopausal gonadotr...
متن کاملاخلاق در کارآزمایی
Background: Clinical trial is the standard method to assess efficacy of a medical intervention. Because of its experimental nature, meaning that subjects are exposed to an intervention with uncertain outcome and according to historical evidences of criminal researches, clinical trial is of something of a lightning rod for ethical concerns. Ethical issues surrounding clinical trials are very per...
متن کاملP-191: A Comparison of The Effects of Transdermal Estradiol and Estradiol Valerate on Endometrial Receptivity in Frozen-Thawed Embryo Transfer Cycles: A Randomized Clinical Trial
Background: The aim of this prospective randomized clinical trial was to determine the optimal endometrial preparation protocol by comparing the clinical outcome of two methods of endometrial preparation in FET cycles, that is, oral estradiol and 17 β-estradiol transdermal patch. Materials and Methods: A total number of 90 patients were scheduled for FET. In the study group (n=45), 17-B estradi...
متن کاملThe effect of bromocriptine-rebound method on ongoing pregnancy and live birth after intracytoplasmic sperm injection cycles: a randomized clinical trial
Purpose: To assess whether bromocriptine-rebound method (BRM) can improve pregnancy outcomes compared to long protocol after intracytoplasmic sperm injection cycles (ICSIs). Materials and Methods: A total of 114 women underwent ICSI. Pregnancy outcomes and hormonal data were compared between two groups, i.e. long protocol and BRM. Ovulatory women with normal serum prolactin levels wer...
متن کاملSPIRIT 2013 statement: defining standard protocol items for clinical trials.
The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a cli...
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:
- Epidemiologia e psichiatria sociale
دوره 19 2 شماره
صفحات -
تاریخ انتشار 2010