Regulatory Focus™ > News Articles > NIH Clinical Research to Undergo 'Paradigm Shift' Under New Research Plan

NIH Clinical Research to Undergo 'Paradigm Shift' Under New Research Plan

Posted 27 September 2012 | By

The National Institutes of Health (NIH) announced on 25 September the launch of a new clinical trials network it hopes will broaden the scope of research to include more real-world research settings while making it easier for patients to enroll in studies.

The network, known as the Health Care Systems Research Collaboratory (HCSRC), will engage with existing healthcare systems such as health maintenance organizations to conduct, "Large-scale and more cost-effective clinical research within the settings where patients are already receiving their care."

Calling the program a "paradigm shift in clinical research," NIH Director Francis Collins explained that the program should be able to achieve two otherwise elusive goals: getting additional patients to participate in research while allowing products to be used in more predictable and reliable settings.

NIH will fund the network with an $11.3 million grant during its first year, with additional funding to come in subsequent years. It is, to be sure, a small amount of money relative to both the NIH's own $30 billion budget and the cost of a single phase III clinical trial, the cost of which can easily run into the hundreds of millions of dollars.

Rather than funding an entire trial, the funds will instead go toward supporting eight "high impact" clinical studies NIH says it hopes will, "Provide a framework of implementation methods and best practices that will enable the participation of many health care systems in clinical research."

The initial pilot programs are set to include pharmaceutical and medical device products as well as more general healthcare topics, such as how to reduce infection-related readmissions to hospitals. The trials are all being conducted at existing facilities, which include several university hospitals and two Kaiser Foundation hospitals.

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