Clinical Trials Articles

In the world of clinical trials, we create detailed development plans, craft thorough study designs, and manage our trials with precision and care. However, the back side of that equation, medical writing of the final study report or clinical study report (CSR), is often a low priority.

Given the years of experience and thousands of clinical studies that have been performed using Electronic Data Capture (EDC), one could be forgiven for thinking that EDC processes are as firmly established as other data management activities. Surely EDC has become as routine as other clinical processes like coding or protocol development, hasn't it?

The use of CROs, an expanding multibillion dollar business, is expected to continue its growth in the coming years.1 And since overall R&D costs and productivity represent one of the most pressing issues industry leaders face today,2 outsourcing will almost certainly continue to play a major role in drug development.

As a population, we have greater access to information than ever before. Couple this with challenging economic times and the result is an environment in which things are no longer accepted at face value. This trend is impacting all industries, including drug development.

The State of Comparative Effectiveness

In clinical development, the gold standard for establishing a therapy's safety and effectiveness is, of course, the controlled clinical trial. Yet we all know that the body of data accumulated during trials is not sufficient to adequately predict a product's future performance in the real world.

It is essential that rare diseases be made a priority at the European level, in order to deal properly with the needs of several million citizens suffering from misdiagnosis, and thus receiving no treatment to cure their diseases." That is the bold introduction to the document currently being debated in the European Union.

A critical component of the Obama administration's health reform campaign is to expand adoption of electronic health information systems. The recently enacted economic stimulus legislation provides $19 billion to support use of electronic health records (EHRs) by doctors and hospitals and to develop standards and systems supporting electronic health information exchange.

CTMS Integrates Data for Efficiencies

Product includes claims data for site identification

A new law that imposes very stringent requirements on the educational background and continuous medical education levels of staff at CROs, as well as the need for quality accreditation, is causing confusion and raising concerns in Italy.

As a light on the gray horizon, so shines the upcoming Biotechnology Industry Organization (BIO) International Convention, otherwise known as BIO 2009.