ISR Reports Breaks Down: 2013 Late Phase Market Overview and Outlook

March 7, 2013
Jeremy Klein

Applied Clinical Trials

This blog entry is based off ISR’s “2013 Late Phase Market Overview and Outlook” report, which was developed based on data from 129 industry professionals with responsibility for Late Phase study conduct and outsourcing. The report includes market data and analysis on Phase IV, Phase IIIb, HEOR, registries, and comparative effectiveness studies.

Late Phase Study Conduct and Outsourced Opportunity
Consistent with much of ISR’s research, study sponsors report a high degree of outsourcing of Late Phase studies (ranging from between 48-61% depending on study type); typically more than in earlier phases of development. Respondents anticipate they will be outsourcing at least one-half of their late phase study budgets over the next 12 months.

Study specific volume and outsourcing - Respondents are clear in their expectations that Phase IV studies will be on the rise, both in terms of total studies conducted and those outsourced.

Late Phase Study Conduct and Outsourced Opportunity

“Regardless of whether studies are conducted in-house or outsourced, for each of the following types of late phase studies, please indicate the growth or decline in the total number of studies your company will conduct in 2014.”  (Base = 129 respondents)
 
“Now, for the studies that your company outsources, for each of the following types of late phase studies, please indicate the growth or decline in the number of outsourced studies your company will conduct in 2014.”  (Base = 129 respondents)


All data points for the above chart are available in ISR’s full report. The following study types are excluded from the above chart: Clinical experience trials, Compliance / adherence, Disease registries, Expanded access programs (EAP), Head-to-head comparative effectiveness (CER), Health Economics Outcomes Research (HEOR), Medical / Product utilization, Patient reported outcomes (PRO), Pharmacoepidemiologic studies, Phase IIIb, pregnancy registries, Product registries, and Risk Management Programs (RMP).Late Phase Service Delivery
One of the major topics covered in ISR’s report is service quality of clinical service providers; more specifically the characteristics of a service provider that drive “satisfaction” and “loyalty.”

As was the case the first time ISR visited Late Phase market dynamics in 2010, respondents in the 2013 report indicate that satisfaction, and to a degree loyalty, revolves around timelines’ management and (relatedly) site/patient recruitment effectiveness.

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