Best Practices in Study Feasibility

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 Best Practices in Study Feasibility 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.” (Sponsor n=60, CROs n=18)

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

The

Best Practices in Study Feasibility

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/

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