Letting Investigators Lead

Perspectives on adoption of technology at U.S. Academic Medical Centers and how sponsors will be impacted.
Feb 01, 2009

Amar Chahal, MD
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.

At the micro level, investigators have seen:

  • An increased interest in their thought leadership despite declining trial numbers at AMCs; this is in great measure due to interest in genomics and translational science impacting clinical research, and it increases sensitivity to operational deficiencies within the investigator's institutions
  • Increases in investigator-initiated trials
  • Need for multicentric electronic data collection
  • Increasing control by institutional managers from a regulatory (ethical and privacy/legal) and financial perspective
  • Increasing implementation of top-down measures that are perceived as additional overhead
  • Cost pressures in study grants aimed at decreasing the cost of information infrastructure and management
  • Frustration with management and systems.

A quick review of these factors speaks to the lack of alignment between investigators and their institutional managers. This malalignment contributes significantly to the current state at even those institutions where infrastructure systems efforts are already underway. It follows that trial sponsors are not yet receiving the benefits of these technology implementations.

The current state

Almost all the change this author has seen is reactive to one or more of the component issues listed, with only a few institutions taking a proactive approach. Those that took the proactive road include some institutions that were early winners of the CTSA awards, as well as some institutions with a global perspective.

Within the large reactive group of institutions, changes are being wrought almost exclusively as a response to macro factors at the institutional and environmental level. Very few infrastructure deployments have been driven by the needs of individual investigators.

Of the macro factors, the most significant drivers have been billing and compliance. While these are necessities, investigators and researchers are driven by their need for the collection and management of data, and not quite as much by management issues. Indeed, sponsors share the same priorities with the investigator.

This discrepancy in priorities has led to a clear division of interest in systems infrastructure, and a resulting clear division of duties within institutions. Harmonious implementation and maximal impact have been best obtained when investigators have been allowed to control systems implementation from their perspective, while management functions have been seamlessly implemented through a back-office approach. In instances where the investigator leads, teams have been able to rapidly roll out EDC at a national and international level, while billing, compliance, and control functions have been overseen by specialist teams.

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