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2023 SPAIG Award Honors UNC, Merck, NCI Collaboration

1 December 2023 No Comment
Xiaojing Wang, University of Connecticut, and Michelle Shardell, University of Maryland School of Medicine

Key Contributors
Lisa M. LaVange, The University of North Carolina (nominations)
Joseph G. Ibrahim, The University of North Carolina
Joseph Heyse, Merck
Bill Wang, Merck
Ming-Hui Chen, University of Connecticut
Arvind Shah, Merck
Sungduk Kim, National Cancer Institute
Jianxin Lin, Merck
Donglin Zeng, University of Michigan
Guoqing Diao, The George Washington University
Ethan Alt, The University of North Carolina
Amarjot Kaur, Merck

The Statistical Partnerships Among Academe, Industry, and Government (SPAIG) Award annually recognizes outstanding partnerships among academe, industry, and government organizations while also recognizing key individual contributors and important advances to promote new cross-sector collaborations.

This year, the SPAIG Award honors the collaboration between The University of North Carolina at Chapel Hill Gillings School of Global Public Health, Merck, and National Cancer Institute for their research in clinical trials and outcomes research.

For 14 years, the Gillings School of Global Public Health, Merck, and National Cancer Institute have improved the efficiency of drug development and helped safe and effective medications reach patients sooner. The collaboration has led to the development of innovative and impactful statistical methods and software applicable to pharmaceutical research and yielded an array of positive outcomes, including numerous student dissertations, peer-reviewed publications, seminars, and short courses.

Here, Lisa LaVange and Joseph Ibrahim answer a few questions to give insight into their collaboration.

Can you describe how the collaboration started?

The 2023 SPAIG Award–winning collaboration began in 2007, when Sir Dennis Gillings made an unprecedented donation to the school of public health at The University of North Carolina at Chapel Hill with the vision of using part of those funds to motivate ground-breaking research in clinical trials. The CICT was founded with the mission of establishing collaborative partnerships with industry and government to advance applied methodological research in clinical trials and related areas that would be impactful to drug development, the practice of medicine, and public health. Joseph Ibrahim was named CICT director and has led the center since its inception.

From left: Amarjot Kaur of Merck, Joseph Ibrahim of The University of North Carolina, Guoqing Diao of The George Washington University, Arvind Shah of Merck, and Jianxin Lin of Merck  Eric Sampson/ASA

From left: Amarjot Kaur of Merck, Joseph Ibrahim of The University of North Carolina, Guoqing Diao of The George Washington University, Arvind Shah of Merck, and Jianxin Lin of Merck
Photo by Eric Sampson/ASA

    From the beginning, Ibrahim pursued partnerships with various pharmaceutical companies and government agencies to realize Gillings’ vision. One of the earliest collaborations was with Merck, Sharp, and Dohme, which was established in 2009 and is still going strong. The National Cancer Institute soon joined the collaboration, providing an additional source of funding and bringing the government research perspective to the group. With the support of Merck and other companies, the CICT has grown considerably over the years, adding faculty, supporting graduate students, and resulting in more than 40 publications to date.

    The many statisticians at UNC, Merck, and the NCI have combined their strength and expertise to guide several research projects and software development activities for the past 14 years, and we envision many more years of successful collaboration to come.

    What are the major benefits coming from the collaboration that would not have otherwise happened?

    One of the major benefits of this collaboration has been exposure to important applied statistical research problems arising from real-world issues faced by industry and government agencies that we might not have been exposed to in a university environment. Just a few of the problems addressed to date include innovative design issues in clinical trials, development of statistical methods for treatment crossover during a trial, complex missing data problems, adaptive designs with complex schemes, biomarker studies, incorporation of historical data into the design and analysis of clinical trials, and meta-analysis and network meta-analysis.

    The collaboration has not only led to new methodological ideas—both theoretical and applied—and many novel statistical publications, but has also enabled us to make an impact on the field from both industry and regulatory perspectives. An excellent example of this impact is what is now becoming a standard use of the power prior in both industry and among regulators for the incorporation of historical data into the design and analysis of clinical trials.

    What have been the most rewarding and most challenging aspects of the collaboration?

    The most rewarding aspects have been meeting new applied researchers outside of academia and being exposed to and solving the important applied statistical research problems they bring to the collaboration that make an impact in practice. Impact is the key motivating element for statistical researchers, and these collaborations have greatly facilitated and influenced impact in the field and in statistical practice.

    Some of the most challenging aspects have been the ability to find suitable partnerships when the end goal is to carry out applied statistical methodological work for advancing the field and statistical practice. Not every partnership has this as their primary mission for various reasons, including staff, resources, time, and size. Another challenging aspect has been the ability to secure government funding and identify government researchers with an interest in becoming part of the collaborative team. Their direct input on important research problems we face in clinical trials and related areas has been valuable to the collaboration.

    What advice would you give to individuals and organizations looking to be more collaborative?

    Be more vocal and reach out to one another to form collaborative teams in which each member brings a unique skill set to the table. Such teams can be powerful and impactful from a statistical research perspective. Also, encourage leaders in the field to advocate for and support such collaborations with their co-workers and provide appropriate resources to make such collaborations thrive, be sustainable, and be fruitful.

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