Design of Phase III Clinical Trials

نویسنده

  • Stephen L. George
چکیده

برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید

ثبت نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

منابع مشابه

Characteristics of Clinical Trials in Iran: A Sample of 5000 Trials Registered in IRCT

Background and Objectives: A considerable number of clinical trials are conducted in Iran each year. Not much is known about the characteristics of them, this study aimed to investigate key characteristics of Iranian clinical trials.   Methods: All clinical trial protocols registered in IRCT until November 2013 were selected. Text mining techniques were used to extract information from data t...

متن کامل

Integrated phase II/III clinical trials in oncology: a case study.

BACKGROUND Integrated phase II/III trial designs implement the phase II and phase III aspects of oncology studies into a single trial. Despite a body of literature discussing the merits of integrated phase II/III clinical trial designs within the past two decades, implementation of this design has been limited in oncology studies. PURPOSE We provide a brief discussion of the potential advanta...

متن کامل

Suboptimal Dosing Parameters as Possible Factors in the Negative Phase III Clinical Trials of Progesterone for Traumatic Brain Injury

To date, outcomes for all Phase III clinical trials for traumatic brain injury (TBI) have been negative. The recent disappointing results of the Progesterone for the Treatment of Traumatic Brain Injury (ProTECT) and Study of a Neuroprotective Agent, Progesterone, in Severe Traumatic Brain Injury (SyNAPSe) Phase III trials for progesterone in TBI have triggered considerable speculation about the...

متن کامل

Novel designs and end points for phase II clinical trials.

The large number of negative phase III trials in oncology over the last several years has renewed interest in refining phase II oncology clinical trials to maximize the chances of success in phase III testing. More efficient phase II study designs will improve our ability to identify promising agents for testing while accurately identifying nonefficacious agents. Recognizing that new paradigms ...

متن کامل

Effectiveness studies: advantages and disadvantages

In recent years, so-called "effectiveness studies," also called "real-world studies" or "pragmatic trials," have gained increasing importance in the context of evidence-based medicine. These studies follow less restrictive methodological standards than phase III studies in terms of patient selection, comedication, and other design issues, and their results should therefore be better generalizab...

متن کامل

Phase III trials of targeted anticancer therapies: redesigning the concept.

Randomized phase III trials provide the gold-standard evidence for the approval of new drugs: an experimental treatment is compared with the current standard of care to identify clinically relevant differences in a predefined endpoint. However, there are several problems relating to the current role of phase III trials in drug development including the limited clinical benefit observed for some...

متن کامل

ذخیره 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 نام

اگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید

عنوان ژورنال:

دوره   شماره 

صفحات  -

تاریخ انتشار 2010