The Unintended Consequences of Clinical Trials Regulations

نویسندگان

  • Alex D. McMahon
  • David I. Conway
  • Tom M. MacDonald
  • Gordon T. McInnes
چکیده

Alex McMahon and colleagues critique the International Conference on Harmonisation (ICH) guidance on good clinical practice (GCP), arguing that it is having a disastrous effect on noncommerical randomized clinical trials in Europe.

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

The Deer Hunter: the Unintended Effects of Hunting Regulations

To control the deer population, state game commissions regulate the types of deer that can be legally harvested. These regulations, however, might have an unintended effect on hunting-related accidents by changing the care hunters take when firing their rifles—a moral hazard effect—or changing the composition of hunters. Using detailed data on hunting accidents and regulations in Pennsylvania c...

متن کامل

Reports of unintended consequences of financial incentives to improve management of hypertension

BACKGROUND Given the increase in financial-incentive programs nationwide, many physicians and physician groups are concerned about potential unintended consequences of providing financial incentives to improve quality of care. However, few studies examine whether actual unintended consequences result from providing financial incentives to physicians. We sought to document the extent to which th...

متن کامل

Clinical trials in molecular imaging: the importance of following the protocol.

Nuclear medicine technologists and investigators who perform imaging procedures in clinical trials often have not received training on clinical research regulations, such as Title 21, part 312, of the Code of Federal Regulations or Good Clinical Practices. These regulations directly affect implementation of the therapeutic or imaging protocol. Lack of understanding of the regulatory expectation...

متن کامل

Randomised Controlled Clinical Trials – The influence of this methodology on the development of theory in Psychotherapy: Some Ruminations

The pragmatic utility, for the day-to-day practise of Psychotherapy, of having an evidence base demonstrating that as a discursive genre, it is as efficacious as medication in facilitating emotional, cognitive and behaviour change, is crucial. This comparative outcome data has been gathered using Randomised Controlled Clinical Trials (RCTs), a methodology that has established itself as ‘The Gol...

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 6  شماره 

صفحات  -

تاریخ انتشار 2009