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

 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 electronic medical record (EMR) data as positive innovations. CROs point to improved feasibility surveys and better targeting questions as ways to improve study feasibility estimations. ISR also collected insights to improve the accuracy of study feasibility estimates 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; and the data sources utilized for feasibility analyses and a ranking of which data sources contribute to the accuracy of the estimate.

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Survey drills down on the preferred methods of sponsors, CROs, and sites in conducting feasibility analysis.

Best Practices in Study Feasibility

	In ISR's 2015 Adaptive Trials: Market Dynamics and Service Provider Benchmarking report, a key takeaway reached is that the primary driver of adoption of adaptive designs is the ability to reach critical decision points earlier. This does not necessarily mean that trial timelines are shorter or costs are lower, but instead that the probable outcomes of these trials are determined earlier so resources can be more effectively allocated to more promising or profitable drugs or devices. ISR found this as a chief motivator for the continued growth of adaptive trial designs. While only 49% of respondents report that they are currently conducting a trial with an adaptive design, 82% anticipate they will be over the next 12 months.


	Faster Go/No-Go Decisions the Top Driver

	When ISR asked respondents what their main reasons were for conducting trials with adaptive designs, 63% said to make earlier go/no-go decisions.

	The primary hesitation associated with using adaptive trial designs relates to the regulatory environment surrounding adaptive trials. Upwards of 60% of ISR's survey respondents perceived adaptive trials as at least "somewhat risky."

Faster go/no-go decisions is the primary driver of adaptive-design adoption by sponsors.

ISR

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Best Practices in Study Feasibility

Adaptive Trial Designs Gaining Momentum