Regulators and patients driving demand for Phase IV studies, says Quintiles
In the clinical sector, observational research is the collection of data in an organised fashion - under a protocol, but where no intervention is prescribed by that protocol - aimed at observing real world treatment decision and outcomes.
While such research can be done in Phase I/II clinical studies - to look at the natural history of a disease and the current medical treatments available, for example - it is in the post-marketing phase of a drug that sponsor demand has been growing, according to Zia Haque, Senior Director of Data Management at Quintiles.
“This part of the clinical research cycle has definitively expanded in the past 10-15 years,” he told Outsourcing-Pharma. “Where in early research, the question is ‘Does this drug work?’ in post approval research, the question becomes ‘Does this drug work in the real world?’”
The value of tracking drugs post-approval in order to gauge their suitability in real world settings is becoming more important to sponsors, with regulators and patients taking a more active role post-approval, he continued.
“An approved medication’s extrapolation to the broader population is only possible by studying the drug as it is prescribed outside of strictly controlled clinical trials. This has led to a stage where regulatory authorities insist on more Post Approval Safety Studies (PASS) as a condition for approving a NDA,” he said.
“Patient advocacy and the easy availability of information about medications in our changing world have also contributed to the desire by patients for more evidenced-based decision making from the physician communities.”
This is driving observational methods for data collection on approved treatments, he added, and “CROs that deal with the end-to-end, or full spectrum of clinical investigations, are well positioned to identify the niche differences on observational studies and guide sponsors appropriately to ensure overall success.”
Quintiles and observational research
Quintiles, the largest CRO based on revenues, has made several moves into the observational research space, with last year’s addition of Encore Analytics complementing the 2011 acquisition of Phase IV observational services firm Outcome Sciences.
“Our Real-World & Late Phase division is solely focused on the science and operations of observational research – among other key late phase activities such as benefit-risk management,” Haque said.
“We lead with science and integrate the support of our Epidemiology team throughout not only study design and reporting, but through all aspects of the project, such as site selection, patient retention, data review and analysis.
