Regional variability and efficient drug development based on ICH E17 guideline; Multi-regional clinical trials

International Concil for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Ich Harmonised Guideline General Principles for Planning and Design of Multi-regional Clinical Trials E17

Regional Clinical Guideline for the Management of Stable Angina

Background and purpose: Prevalence of risk factors for health is growing rapidly in developing countries due to urbanization. In fact much of the global burden of some conditions such as ischemic heart disease is currently in low- and middle-income countries. Therefore, an integrated and effective clinical guide is highly needed for management of patients with stable angina. Materials and meth...

Regional pathologies and globalization of clinical trials: has the time for regional trials arrived?

Trials: Has the Time for Regional Trials Arrived? To the Editor: We read with great interest the series of articles written by Drs Califf and DeMets1,2 regarding the lessons learned from cardiovascular clinical trials performed during last 2 decades. Indisputable evidence obtained from several large clinical trials conducted mostly in white populations with chronic heart failure (CHF) clearly d...

Statistical principles for clinical trials (ICH E9): an introductory note on an international guideline.

The opportunity to write a truly international guideline on statistics is a rare one indeed. In 1995, the Steering Committee of the International Conference on Harmonisation1 (ICH) took a decision which was of major importance to all medical statisticians involved in the development of new medicinal products. This decision was to add a guideline on statistical methodology (E9) to the collection...

Registration of clinical trials--a regional perspective.

The birth of the scientific clinical trial is often cited as an experiment by James Lind. On 20 May 1743, Lind compared the effect of a few supposed nutritional remedies against scurvy. The research subjects, 12 sailors suffering from scurvy on board the ship HMS Salisbury, were divided into 6 groups. In one group, each patient was given 2 oranges and 1 lemon every day, to eat upon an empty sto...