National guidelines on clinical trials with the use of pharmaceuticals products – 2005

Abstract

Introduction: In view of the rapidly growing body of health knowledge and technology globally, rising aspiration of Nepali people to have the access to high quality medical care at an affordable price and, given the need to use the available limited resources in the most cost-effective way, we, as a nation, can not afford not to base our health related actions / decisions on the appropriate evidences substantiated by a valid database. While it might be advantageous for us to learn and benefit from the experiences gained elsewhere in the world, one should always keep in mind that due to the inherent biological variability and different environmental conditions, not all of the internally valid data and conclusions derived from the studies conducted in other populations may be generalizable and therefore may not be applicable to our own population. It is high time therefore that we not only continue generating relevant, important and scientifically valid data that are based on our population but also make every attempt to validate the inferences drawn from studies undertaken elsewhere before applying them on our own population. Needless to say, only by harnessing our own national potential, will we be able to deal with this challenge in a sustainable way. It is only natural therefore that we expect our national professional and academic community to rise to the occasion and take the lead in pursuit of scholarly inquiries (and thereby generate valid scientific database) in the spirit of identifying, characterizing as well as finding answers to our existing and emerging national problems of biomedical, clinical and public health nature. It is in this context that we should appreciate the value of clinical trials and should do everything possible to encourage and promote the scientifically sound and ethically justifiable clinical trials conducted among the Nepali populations