Letting Investigators Lead

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.

This article will examine the drivers and strategy behind current initiatives for clinical trial systems at AMCs, their near-term impact, and the possible future evolution based on scientific, financial, and operational changes. In doing so, we consider what this means to both sponsors and the industry as a whole.

Issues at hand

For the past 40 years there has been a significant decline in the global share of clinical trials conducted at U.S. AMCs. The last decade has seen significant changes in the milieu for clinical trials at these centers. They include environmental changes (macro) and investigator level changes (micro). At the macro level, AMCs have seen:

* Increasing risk and cost for compliance in terms of conduct and billing
* An erosion of competitiveness from an operational perspective
* An increasing cost disadvantage, as many industry trials have moved offshore
* Increasing competition for government funding
* A desire to collaborate that's driven by overarching change in funding, like the NIH's Clinical and Translational Science Award (CTSA)
* A need to control multiple system proliferation and to standardize information
* Increasing complexity of trials and recruitment in clinical research with a genomic basis.