ISR Reports

Successfully navigating the medical, clinical, logistical and regulatory challenges associated with establishing the feasibility of a clinical trial is not easy. Insights from sponsor organizations, CROs and sites have been compiled in ISR’s 

 report. A particular area of interest for readers of the report are the techniques and innovations proffered by sponsors and CROs for conducting feasibility analyses. Both groups identified that the integration of statistical modeling and knowledge of past performance into feasibility analyses is positively impacting the process. Sponsors also see value in making direct, personal contact with investigators to build better relationships and a greater use of EMR data as positive innovations. CROs point to improved feasibility surveys and better targeting questions as ways to improve study feasibility estimations.	 	

“In terms of a feasibility analysis, what are some of the best techniques or innovations you have experienced? Please be as specific as possible. Thank you.” 

	In addition to findings on the top techniques and innovations used when conducting a feasibility analysis, ISR has collected additional insights to improve the accuracy of study feasibility estimates in its Best Practices in Study Feasibility report, including:	

		The percentage of trials that require a feasibility analysis, and whether the analysis is conducted in-house or outsourced

		Awareness of feasibility analysis service providers and frequency of use

		The data sources utilized for feasibility analyses and a ranking of which data sources contribute to the accuracy of the estimate

		Which characteristics comprise a predictive feasibility estimate, impressions on the industry’s approach to feasibility analysis and the use of SOPs (standard operating procedures)

		The accuracy of the estimations received from CROs, sites and specialized feasibility analysis firms as well as the potential value to be gained by engaging a specialized feasibility analysis firm under specific circumstances

		Performance and satisfaction levels in working with 23 different specialized feasibility analysis firms and 49 CROs offering feasibility analysis services

 report is a useful tool for all parties involved in study feasibility estimations, whether at the sponsor organization, CRO, specialized feasibility firm or site. The report will aid readers in knowing the most effective techniques and innovations used to establish accurate feasibility estimates, when to consider engaging a specialized feasibility analysis firm and how to implement the best practices used by industry peers. For more information about the report, please visit ISR’s report page at 

https://www.isrreports.com/reports/best-pratices-in-study-feasibility/

Articles

This Best Practice in Study Feasibility report covers techniques and innovations proffered by sponsors and CROs for conducting feasibility analyses.

Best Practices in Study Feasibility

	The stakes are high when it comes to clinical trials. Each day a trial goes beyond its intended deadline delays treatment for patients who would benefit from the medication and puts the sponsor organization at risk for lost revenue. Industry Standard Research’s 

 report, based off of primary research with sponsors, CROs, and sites, includes an in-depth analysis of the industry’s strategies for completing a trial on-time and within budget.
	
	One of the key findings in the report relates back to the use of specialized patient recruitment firms. According to both sponsors and CROs, engaging a specialized patient recruitment firm is a better value than adding more sites to the study. This is, in part, due to specialized recruitment firms having their own database of patients-one of the most important resources when recruiting for a clinical trial. As detailed in the chart below, the bulk of patients currently come from 

Existing patients at sites / in-house patient databases

. While this is predicted to remain true for the next two years, respondents anticipate a smaller proportion of patients will come from in-house site databases by 2018.  
	
	

“Currently, what percentage of your patients are recruited directly via the following sources?  Your responses should add to 100%.”

ISR has collected additional insights to improve the efficacy of recruitment efforts in its Best Practices in Patient Recruitment report, including:

		Which study characteristics drive patient recruitment success, the value of various recruitment tactics and the best sources for recruiting patients

		Which entity (sponsor, CRO or site) has the greatest impact on recruitment success

		Approaches to recruiting for a global trial, country selection factors and challenges encountered in recruiting for global studies

		Performance and satisfaction levels in working with 18 different specialized patient recruitment firms and 50 CROs offering patient recruitment services

 is a valuable tool for anyone charged with patient recruitment. It will assist readers in knowing when and how to engage a specialized patient recruitment firm to get the best value and how to implement the best practices identified by industry peers to improve the likelihood of your trial finishing on-time and within budget. For more information about the report, please visit ISR’s report page at 

http://www.isrreports.com/reports/best-practices-patient-recruitment/

This Best Practice in Patient Recruitment report displays what percentages of patients are recruited from and where.

Best Practices in Patient Recruitment

The following data points and discussion have been extracted from the “

2013 CRO Quality Benchmarking – Phase II/III Service Providers

” report released by Industry Standard Research (ISR) on April 23, 2013.        

Phase II/III Outsourcing to Maintain Growth in 2013

The outsourcing of clinical development continues to rise. Sponsors estimate that in 2012 they increased outsourcing of Phase II/III services by an average of 7%. This trend should continue in 2013, as outsourced study volume is expected to increase by 8% over the next 12 months.

In 2012, the CRO industry’s focus was on preferred provider agreements, M&A activity, and tools to help reduce cost... Was anyone asking the sponsors what they wanted?

ISR asked 157 respondents with responsibility for clinical outsourcing of Phase II/III studies and received some thought-provoking feedback: 

Given the option, 75% of sponsors would prefer 10% faster recruitment timelines to 20% reduction in trial costs.

A similar sentiment was reflected when comparing findings between ISR’s 2012 and 2013 reports in which ISR asked respondents to identify the most important criteria used when evaluating and selecting clinical service providers: 

 ranked as the 4th most important attribute. When ISR asked the same question and offered the same responses in 2013, “Low Cost” dropped two spots and ranked as the 6th most important attribute.

ISR’s take – As seen in the chart and discussion above, “Low Cost” remains a factor when selection of clinical service providers. However, it appears that sponsors are willing to overlook the higher price tag to partner with a provider with proven service quality records, study experience, and innovative services.

While we understand more goes into the selection of a clinical service provider than “past experiences,” ISR feel that “Preference” – based mainly on those past experiences – plays a significant role in that evaluation and selection process.

Of service providers you’ve used] which would you prefer to work with for Phase II/III services if the decision were completely up to you?”

 received the highest ranking out of all CROs measured – with half (50%) of its current and past customers indicating they prefer to use them again for their Phase II/III studies.

The 5th annual “CRO Quality Benchmarking - Phase II/III Service Providers” report provides pharmaceutical sponsors and clinical service providers with an independent and comprehensive analysis of CRO service quality and clinical outsourcing of Phase II/III clinical trial services. In addition to the outsourcing market dynamics and CRO selection/evaluation criteria discussed above, this year’s the report includes over 470 service evaluations of 29 CROs across 26 critical characteristics associated with service quality.

More information is available on ISR’s website: 

http://www.isrreports.com/industry-reports/2013-cro-quality-benchmarking-phase-ii_iii-service-providers

ISR discusses Phase II/III Outsourcing Growth, CRO Selection, and Sponsors' Preferences from Latest Report

What are the most important factors in selecting a Phase I service provider? 

That depends how we look at the data from ISR's latest report, "2012 CRO Quality Benchmarking—Phase I Service Providers." Of the 61 executives responsible for Phase I study conduct and outsourcing, more selected "prior positive experience with a service provider" than any other attribute as the single most important driver of selection. However, when asked to indicate their top five drivers of selection, more respondents chose "access to patient populations" among their top five than any other attribute.  

 Attributes that fuel service provider selection.			

This is notable considering the other 20 attributes respondents had to choose from are historically critical skills such as therapeutic expertise, project management, timelines management, and even the experience of the Phase I unit's lead investigator.  

For now, historical relationships will continue to get a Phase I provider invited to bid. 

 Going forward, the ability to demonstrate patient—not just healthy volunteer—recruitment capabilities will make the difference between a win and a loss. 

ISR Reports

Articles

Best Practices in Study Feasibility

Best Practices in Patient Recruitment

ISR discusses Phase II/III Outsourcing Growth, CRO Selection, and Sponsors' Preferences from Latest Report

Selection of Phase I Service Providers