New FDA Guidelines Could Benefit CRO Industry and Research Triangle Park
New FDA Guidelines Could Benefit CRO Industry and the Triangle
Aug. 16--New federal guidelines that encourage the pharmaceutical industry to consider a non-traditional approach to monitoring clinical trials of experimental drugs could be a long-term plus for the Triangle's contract research organizations.
The guidelines, finalized this month by the Food and Drug Administration, establish the framework for a more tailored approach known as risk-based monitoring.
"I think this is a very strong signal for the industry to move forward with this," said Mark Shapiro, executive director of clinical development at Clinipace Worldwide, a Morrisville clinical research organization with 463 employees.
Drug companies that decide to give risk-based monitoring a try are more likely to outsource the work to contract research organizations, or CROs, because switching requires an up-front investment, said analyst Tim Evans of Wells Fargo Securities.
Drug companies "would prefer to have their partners make these investments rather than make those investments themselves," Evans said.
The Triangle is the epicenter of the expanding CRO industry, which helps pharmaceutical and biotechnology companies test experimental drugs. The region is home to three of the world's eight largest CROs, including category leader Quintiles, PRA International and INC Research.
John Kreger, an analyst at William Blair & Co., estimates fewer than 10 percent of clinical trials rely on risk-based monitoring today. He also is convinced that adoption is poised to accelerate.
CROs such as Quintiles have been investing in the technology and processes needed for risk-based monitoring for years. The FDA officially got on board two years ago with draft guidelines, which formed the basis for the final guidance issued this month.
"This isn't a revolution," said Dan White, vice president of global operations at Quintiles, which employs more than 2,000 in the Triangle. "This is an evolution."
Monitoring clinical trials is one of the most important, and most expensive, components of the drug-testing process. It includes, among other things, verifying the accuracy of data, keeping an eye out for the safety of patients who volunteer to participate in the trials and making sure that the test protocol is followed.
Some analysts, including Evans, believe that risk-based monitoring will be more profitable for CROs because it relies more on technology and less on personnel.
But that doesn't mean job cutbacks are on the horizon. "The industry is growing so quickly and this change is going to happen so slowly," Evans said.
On the upswing
The CRO industry is on the upswing due to increased research-and-development spending by drug companies and a trend toward outsourcing clinical trial managements.
The traditional way of monitoring a major clinical trial is to send a monitor to each test site -- a doctor's office, hospital or other medical facility -- every four-to-eight weeks.
It's a one-size-fits-all approach that originally was dictated by the use of paper documents. It has endured even as the health care industry -- and the managers of clinical trials -- switched to electronic data.
"Ten years ago, probably every monitoring plan at every CRO was almost interchangeable," said Clinipace's Shapiro. "They all looked the same ... What the FDA is calling for is a much more customized approach."
Risk-based monitoring is a more strategic process that, as the name implies, involves allocating resources to where the risk is greatest.
In this context, the risks are two-fold -- the potential risks to patient safety and the risks to the integrity of the clinical trial, such as a high frequency of data error or data anomalies that raise questions.
White, with Quintiles, says that the name risk-based monitoring is misleading.
"We are actually de-risking our monitoring," he said. "It is really about understanding risk ... and using your assets -- your technology and your people -- to mitigate those risks with laser focus."
One component of risk-based monitoring is greater reliance on remote monitoring.
"Instead of the monitor looking at the data independently at each site, we might be looking at data across the sites," said Lynn King, assistant vice president of operations at Rho, a Chapel Hill CRO with about 350 employees. "So we can see where there are outliers in data results that will allow us to focus on site issues."
The emergence of significant issues can trigger on-site monitoring.
All of this involves performing sophisticated analyses of the data.
According to the FDA, there is a growing consensus that risk-based monitoring does a better job of protecting patient safety and ensuring the quality of a clinical trial.
"Several publications suggest that certain data anomalies (e.g., fraud, including fabrication of data, and other non-random data distributions) may be more readily detected by centralized monitoring techniques rather than by on-site monitoring," the FDA noted in its guidelines.
Given that monitoring is frequently the largest single expense item in a clinical trial, accounting giant PricewaterhouseCoopers estimates that risk-based monitoring can reduce costs by 15 percent to 20 percent due to reduced travel costs and fewer monitors per study.
Although any single clinical trial might cost a pharmaceutical company less, Evans believes the money a drug company saves is likely to be plowed into other trials.
"I just think it gives (pharmaceutical companies) more capacity to do more things, which is a positive for the CRO industry as a whole," he said.
But the shift to risk-based monitoring is expected to be gradual.
"Even with this final guidance document ... there will still be an adjustment period," said Rho's King. "The industry is looking for how the FDA will now interpret and apply this guidance document. The bottom line is they want to see how this will affect submissions for drug approval."
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Posted: August 2013