Mounting costs and increased pressures over safety and efficacy have led to the cost of clinical trials, and the time taken to complete them, to skyrocket. But as is being witnessed in the H1N1 swine flu outbreak – that still threatens to develop into a full-scale global pandemic – the expensive, cumbersome process must change if modern-day medicine is to combat the globalised health scares of the 21st century.
In June, industry leaders will meet at two VIB conferences to discuss how the clinical trials process can move forward. The first, CNS Clinical Trials, will discuss how complex central nervous systems trials can be advanced and, in particular, the challenges in recruiting patients suffering from mental disorders. The second, Clinical Trials Supply USA West Coast, will be held across the Atlantic but will share the common theme of trying to push forward large-scale, global trials.
Often, the further down the life of a clinical trial, the more expensive and pronounced the problems can become. Once a safe bet in the global stock markets, big pharma stocks have shown they are not resistant to global economic pressures – and late-stage trials are taking a battering.
Some drug development firms have taken drastic measures to reduce their liability. France's Sanofi, for example, recently took a knife to its pipeline – slashing 14 drugs in development, including four in final stages.
For Sanofi, even the previous investment that had gone into the early phases could not justify the additional expense needed to bring these trials to market.
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For its executive director for phase IIIb/IV product development, Scott Cooley, the system needs to change. "The industry is not satisfied with the current state of the research model and it is transforming in a number of ways," he says.
The statistics of risk
For Cooley, the priority is ensuring the maximum exposure to molecule is combined with effective risk-based statistical sampling and continued patient monitoring, even when the drugs are in the marketplace. "We want to look at transforming the research so that we have greater safety profiles," he says. "We don't necessarily want to use a model that encourages the old-fashioned approach that says, 'launch the product and if you watch carefully you will catch the defective parts'."
One way Quintiles is pushing this reform is through the set-up of its central monitoring team. This specialised group liaises with investigative sites during trials, including once the product is in the post-marketing phase.
"They train and work with the investigators to make sure they understand the protocol, their obligations to research and to make sure we take whatever measures we can to ensure subjects are treated appropriately and we meet the data goals of the study," says Cooley.
A few embarrassing cases where drugs have gone to market and have since had to be removed have shaken up the industry. As sample groups get ever larger and more geographically spread, the science of statistics is becoming an increasingly useful tool. "Mostly in the past we have thrown mass at studies – we look at every single data point and ironically the methods we use so creatively when we step away and begin analysis have not been used in the gathering of the data itself," Cooley explains.
But rather than embracing the advantages that sophisticated statistical sampling can bring, drug companies are often reluctant to embrace these techniques and worry that their reputation may be put on the line by practices that some people may wrongly view as cutting corners.
Ironically, it appears to be the watchdog organisations that are proving most forward thinking. "I think the people who are embracing it the most are the regulators themselves," says Cooley. "They clearly see that some transformation of the research enterprise must happen." For Cooley, a shift in how the industry views the regulators must take place to advance clinical trial research.
"It is in the public's interest that we have novel therapies and a lot of people see regulators as obstacles that must be overcome," he adds. "If you shift your thinking a little and view them as the holders of public trust, then their role is to bring safe therapies forward."
Three becomes two
Quintile's chairman Dr Dennis Gillings said the ideal for drug development firms would be for three clinical trials to be conducted in the time – and with the resources – that is currently needed for just two.
To go some way toward bridging that gap, Cooley is working on getting more risk-based monitoring into studies. To do this, however, preliminary work needs to be completed on standardising variables.
Electronic data capture is likely to be an invaluable tool in achieving the "three becomes two" aim, as is the introduction of clinical imaging and biomarkers. Again, it is the regulators that seem more advanced than some industry members in embracing these tools.
With regulators driving advancements in technology and clinical trial methodology, transforming clinical trials is now down to the adaptability and receptivity of the drug companies themselves. With a trend towards outsourcing already gaining pace, the scene could be set for a dramatic shift in the design of tomorrow's drug trials.