Regulatory Focus™ > News Articles > IOM: Regulatory Holds Promise of Improving Healthcare Outcomes

IOM: Regulatory Holds Promise of Improving Healthcare Outcomes

Posted 10 September 2012 | By Alexander Gaffney, RAC 

A new, landmark report just published by the US Institute of Medicines (IOM) says the US healthcare system spends more than $750 billion each year on wasteful and inefficient systems of healthcare, and calls for changes, including to the US Food and Drug Administration's regulatory system.

The report, "Best Care at Lower Cost: The Path to Continuously Learning Health Care in America," examines the burgeoning cost of healthcare, which IOM officials say, "Threaten the nation's economic stability and global competitiveness." The way forward, they say, will take a concerted effort on the part of all stakeholders in the system, including regulatory professionals.

New Approaches to Clinical Trials

Regulatory approaches will need to be changed to improve care and lower costs, said IOM.

"Harnessing this potential for care improvement will require systematic approaches that address the regulatory, commercial, communications, and technological challenges involved," IOM wrote. One of their targets: privacy rules for clinical trials and research that researchers said were skewed too heavily toward protecting patient privacy to the detriment of cost-effective research and product development.

"Results of surveys of health researchers suggest that the current formulation and interpretation of privacy rules have increased the cost and time to conduct research, impeded collaboration, and hampered the recruiting of subjects," IOM argued. "Privacy is a highly important societal and personal value, but the current rules, with their inconsistent interpretation, offer a relatively limited security advantage to patients while impeding the pace and scope of new insights from health research and care improvement."

Harnessing opportunities to leverage clinical trials will also be important to maximize value within the healthcare system, the report explained. Several regulatory initiatives, such as FDA's Clinical Trials Transformation Initiative, promise the introduction of more pragmatic, cost-effective, adaptive and efficient trials.

The marriage of regulatory goals to computing power will also bring new gains in the ability of regulators and industry to glean insights from complicated data, IOM predicted. One example provided was the potential development of digital physiological pathway and disease models, which IOM said could simulate clinical trials and develop clinical guidelines on a per-patient basis.

"As computational power increases, the potential applications of these simulation and modeling tools will continue to advance," IOM predicted.

Information: Too Fast, Too Slow or Too Dumb

The report also takes issue with what it sees as the "overly rapid adoption of some new techniques, devices, and drugs," some of which can lead to harmful effects and be less effective than previous products or procedures. These events often go unseen or undetected by clinical staff or regulators because the lack of electronic patient management systems means regulators are never made aware of a product's dangers.

"For example, one study found that real-time analysis of clinical data from electronic health records could have identified the increased risk of heart attack associated with one diabetes drug within 18 months of its introduction, as opposed to the 7-8 years between the medication's introduction and the point at which concerns were raised publicly," IOM wrote.

IOM cited several studies which claimed that errors involving medications-incorrect dosing, improper administration, medication mix-ups and more-were reduced by more than 80% when subject to a computerized tracking system.

The use of computerized systems can also engender registries with the power to revolutionize how care is administered to patients, IOM explained. In one instance, a disease registry set up to track heart attack patients in Sweden contributed to a 50% reduction in 1-year mortality and a 65% reduction in one-month mortality. "Growing computational capabilities to generate, communicate, and apply new knowledge create the potential to build a clinical data infrastructure to support continuous learning and improvement in health care," they explained.

On the other side of the equation, IOM said some products were approved in the correct amount of time, but adoption of the new and superior product was delayed because of a slow "diffusion of new evidence." In the case of the development of thrombolytics drugs, used to treat heart attacks, more than a decade passed between when they were shown to be a superior and when most experts recommended their use in patients. IOM said new advances in knowledge, research capabilities and dissemination will hopefully help reduce the time between evidence of effectiveness and adoption.

Regulators and the Formation of a 'Learning System'

IOM also called attention to the need to, "Improve the quality and efficiency of care," and took note of the role regulatory has to play in an innovative healthcare system.

"Regulators, including the Food and Drug Administration, play an important role as well in several aspects of the health care system, from the introduction of medical products to surveillance of existing products," the report says. Of particular importance to the system as a whole is the regulatory profession's ability to bring innovative products to market "without delay," the report continued.

The marriage of regulatory and big data also holds the promise of being able to improve care for patients, explained IOM. The report notes that the adoption of digital records, "Presents an unprecedented opportunity," for learning purposes, particularly as they relate to improving clinical trials surveillance, comparative effectiveness research and quality reporting.

These "new linkages" between innovators and regulators will allow for enhanced tools to determine if products are safe and effective, the report says, and will also allow the system to, "Continuously learn and improve."

"On the regulatory level, evidence on a product's effectiveness needs to be updated after the product's introduction," IOM continued, calling attention to FDA's Sentinel and Mini-Sentinel Initiatives, which conduct large-scale product monitoring.

Such efforts should be replicated and expanded, said IOM, with the data obtained from the systems brought into a "learning system" that promotes continuous improvement of the healthcare system.

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