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At a recent conference on post-approval strategies at Harvard, former FDA commissioner and current administrator of Medicare and Medicaid Mark McClellan loosely outlined his vision of an IT network se

By Editor on Oct 12, 2005

At a recent conference on post-approval strategies at Harvard, former FDA commissioner and current administrator of Medicare and Medicaid Mark McClellan loosely outlined his vision of an IT network seamlessly connecting physicians, patients, hospitals, insurers, pharmacies and drug companies to raise the quality of medical care, improve drug safety and lower costs.

Calling the current FDA system for monitoring drug safety inadequate, McClellan said the FDA and the industry should not be reliant on spontaneous adverse events reports from overworked providers.

We are not learning as much as we should about the effectiveness of treatments, he said. But he added, It should not be costly one-off studies that help us get there.

According to a Bio-IT World report, McClellan's vision is of a unified digital infosphere that will link and employ all stakeholders from hospitals and pharma to physicians, pharmacies and insurers to pore over which surgeries/drugs/treatments work and which do not in order to proactively minimize cost and improve health and safety.

And while the infrastructure to support such a community-wide effort is still in the making, McClellan says critical elements are already being instituted by IT-savvy institutions such as the US Veteran's Administration and the Cleveland Clinic.

Judy Hanover, a senior research analyst with Life Science Insights, says the opportunity to improve drug safety by applying technological solutions has made pharmacovigilance risk management one of the fastest growing application areas in the drug development technology arena.

Hanover says while it is easy to blame the FDA's reporting requirements, which she agrees may be inadequate, there is a case to be made for simply working harder to get more information from the data available. And that, she says, is where pharmacovigilance technology comes in.

Pharmacovigilance systems consist of a drug safety case information database with a set of tools and techniques for mining to detect safety signals buried inside the massive data sets, she says.
Drug companies and the FDA must leverage these technologies to make better decisions about drug safety, Hanover says. But both groups have a long way to go before the can effectively put these tools to use to provide actionable, accurate and easily understood information to the market, she predicts.

Intrasphere, a pharma IT provider, says the industry needs to show both regulators and consumers that it is doing everything possible to assure drug safety, while finding more effective approaches to managing drug safety data. And this requires data agility they advise, based on an integrated approach to adverse event data systems and pharmacovigilance coupled with the appropriate business processes.

One of the biggest obstacles, according to David Handelsman, a clinical research and development strategist for SAS, is insufficient systems for sharing clinical trial data throughout pharma organizations.

Because clinical trials for the same drug are often conducted in multiple locations, Handelsman says, enormous amounts of data regarding drug safety are being collected throughout the organization, quite often in disparate systems. And that scattering, he says, means pharma executives lack a clear view of all safety-related criteria, making it difficult to have adequate information, early enough in the process to make accurate decisions regarding the potential safety of a particular drug.

Pharmas need an integrated system for managing, analyzing, reporting and reviewing data from multiple, disparate sources across trials, development phases and therapeutic areas, he says. But he admits, even then, identifying drug safety issues prior to approval can be like looking for a needle in a haystack.

Post-marketing safety data whether collected through the clinical trials process or via government databases often provides the only robust data pool for finding subtle safety issues, Handelsman says.

Scott Gottlieb, a fellow at the American Enterprise Institute and former senior policy advisor to the FDA commissioner, says there is little chance that clinical trials will ever provide a complete review of how a new treatment will perform when it is used in much broader populations of patients in real-world clinical settings. But calls to lengthen trials or require them to include more patients is not the answer and will only add to the cost of drug development and the eventual price of new drugs.

Longer trials will not add a modicum of safety, because the data that these trials generate will never reach a magnitude sufficient to unearth the kinds of side effects that were evident in the case of Vioxx or the SSRIs, he writes in Health Affairs.

The good news, he says, is that new tools can help the FDA address some of the shortcomings that have led to current criticism, without all of the trade-offs in time and cost that come with blunt remedies, such as larger and longer clinical trials.

In particular, information technology, properly deployed, will enable the FDA to pursue fundamentally better ways to monitor the safety and effectiveness of new medical products after they are made available in the marketplace, Gottlieb writes.

The data gaps that plague current FDA review processes, he says, stem directly from passive adverse event information-gathering. More actively gathering high-quality data about how drugs are used in the marketplace and what side effects are occurring could go a long way toward improving drug safety, he argues.

Fixes so far to the system, such as the MedWatch Safety Information System and the Adverse Event Reporting System, while improvements for making data easier to mine for signs of potential safety problems, are only small steps toward fully exploiting IT for the task of drug safety.

Gottlieb says the FDA needs systems that allow it to collect more information about a drug's use in the real-world, in real-time and to use that information more effectively. The first step, he advises, is developing more active reporting systems that will be able to link more directly into electronic medical records and other information tools used in healthcare settings., allowing the FDA to tap electronic health information networks to achieve more active monitoring of health information for selected signals of adverse drug events.

The second step for improving the monitoring of drug safety is to develop better retrospective determination tools, or analytical capabilities for evaluating potential safety signals from data and for establishing causal links between drugs and suspected side effects.

By making more routine use of very large medical data sets, to retrospectively evaluate how many thousands, or in some cases millions, of patients fared when they took a new drug, the FDA would be in a better position to evaluate whether a drug is causing a rare side effect, Gottlieb says.

Drug makers, he says, are in a particularly good position to help expand efforts by creating proactive online registries at the time of drug approval to collect safety data from enough patients until true risk-benefit analysis's can take place. And, Gottlieb says the technology already exists.

With all of the recent advances in the science behind the discovery of new drugs, we should be investing commensurate resources in bringing twenty-first-century science to the task of ensuring [drug] safety, Gottlieb stresses.

To learn more about new technologies and advances in addressing drug safety, register to attend eyeforpharma's Drug Safety for Marketed Drugs two-day conference and expo being held 22-23 November Amsterdam. For more information or to register, visit www.eyeforpharma.com/rxsafety or call the eyeforpharma team at +44 20 7375 7500.