How nQuery helps streamline oncology clinical trials

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Case Study

Highlights

 Oncology group that develops, conducts and coordinates studies


 Was using SAS for all statistical analysis including sample size estimation


 With such varied work in terms of trials and partners, SAS coding was too time consuming


 Different sample size software products were tested before nQuery was selected as it met every requirement


 Immediate benefit using nQuery - No coding, validated software, recognized by all partners and regulatory agencies

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Challenge

The Latin American Cooperative Oncology Group (LACOG - formerly GLICO) is the first multinational cooperative group in Latin America exclusively dedicated to clinical and translational research in cancer.

Founded in 2008 by a group of Latin American medical oncologists interested in the development of clinical research, the primary goals of the group includes:

  • To develop, conduct and coordinate clinical studies (e.g. epidemiologic and POC studies) and clinical trials in the region

  • Cooperate with other international academic institutions and networks, groups and the pharmaceutical/biotechnology industry facilitating the conduct of clinical research.

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LACOGs technology stack primarily consisted of SAS and OpenClinica. SAS is obviously great as a statistical analysis program and while there is a SAS proc for sample size and power it is limited in features and capabilities within certain parameters.

  • This meant biostatisticians at LACOG would have to write SAS programs for different types of studies.

  • Then the procedures would then need to be fully validated for regulatory approval.

This was not only resource heavy, but the correct result could be reached in an alternative way.

Solution

LACOG implemented nQuery as their sample size software of choice for sample size calculations in their clinical research. This meant that they now had access to 100s of validated sample size and power analysis procedures for a variety of trial designs in an easy to use spreadsheet based format.

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Benefits

LACOG noticed the benefits immediately in their oncology clinical trials. nQuery simultaneously simplified LACOG's sample size process while also providing peace of mind that their calculations were conducted in a validated tool for regulatory approval.

  • No Manual Coding
    Using nQuery as their dedicated sample size and power analysis software meant that there was no need to use SAS for sample size calculation, and instead could use it for statistical analysis

  • Reduce Human Error - Use Validated Software
    Having access to nQuery's 100s of validated sample size procedures meant that LACOG can use predefined tables in a spreadsheet interface. This helps with both speed and accuracy

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