Clinical Trials Articles

There has been widespread satisfaction at the decision in February to continue the DAD study (Data Collection on Adverse Events of Anti-HIV Drugs).

A main theme of health reform is to make health care cost and quality information more transparent to better inform treatment decisions by providers and patients. Policy analysts consider a lack of transparency in health care financing a serious problem for the nation's health care system.

In the days when paper ruled, the filing cabinet was its castle. Then, with the transition from paper to computers came the advent of electronic content management (ECM). And voila: Data suddenly had a new home.

Like any industry, the world of life sciences is in a constant battle for more efficient processes. Of course, with clinical trials there is the additional hassle of having to share extensive amounts of data among the multiple players involved in a trial.

Communication Methods in Clinical Trials

Even before the failing economy, I believe we were all doing more in regard to managing our professional and personal lives. You manage your airline reservations, your banking, and shopping via the Internet. While it is maybe more convenient, the onus is on you. What's my password(s)? Did I check-in online, and where is my money today? Professionally, everyone is also doing more.

Arguably, drug development sponsors consider improvements in site selection and management one of their top priorities. Tackling this problem has been very difficult. Investigative site performance is both highly variable and unpredictable.

Over the past several years there has been increasing recognition at Academic Medical Centers (AMCs) in the United States of the important role of software and systems technology in the management and execution of clinical trials. We have worked with more than 15 centers that have made significant investments in new system initiatives within the past three years.

Alot can change in 15 years. Consider how Edwin C. Cadman, MD, described the scene at Academic Medical Centers (AMCs) in a 1994 article: "[There's a] prevailing attitude that patient-related research is easy and can be accomplished at night or on the weekends after spending 60 hours caring for patients and teaching."1

Within the last 10 years, eight University Medical Centers (UMCs) were created in the Netherlands. In a UMC, the faculty of medicine, with its responsibility for the initial training of physicians and for scientific research, is merged with the academic hospital, with its responsibility for tertiary care and clinical research and innovation.

It's true. What many have pitted as perennial foes in the battle for industry-sponsored drug trials—with the Academic Medical Centers (AMCs) as underdog—is changing. What history may show in regard to the use of AMCs in industry-sponsored drug trials remains to be seen. But in just the past few years, there has been a recent upswing among CROs and AMCs that are collaborating.