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Clinical Trials and Academia: Goodness of Fit

1 March 2011 2,150 views No Comment
This column is written for statisticians with master’s degrees and highlights areas of employment that will benefit statisticians at the master’s level. Comments and suggestions should be sent to Keith Crank, the ASA’s research and graduate education manager, at keith@amstat.org.

Contributing Editor
FanGloria Broadwater is a senior statistician in Duke Cancer Institute’s Cancer Statistical Center. She earned her bachelor’s degree in mathematics from Frostburg State University in Maryland and master’s in statistics from Virginia Tech.

The role of a statistician in Duke Cancer Institute’s Cancer Statistical Center is to analyze and interpret clinical trial data with the goal of publishing results in professional medical journals. Reaching this goal involves several steps in which statisticians are actively engaged.

The process typically begins when medical investigators consult with me to discuss the goals of a clinical trial. I may meet with the investigators alone or receive guidance from a PhD statistician. In addition to educating the investigators about good research practices, I assist the investigators in writing the protocol by translating their objectives of the clinical trial into formal statistical hypotheses. Then, I develop a statistical design for the trial with statistical justification to test the hypotheses, including power calculations and sample size estimates. A statistical analysis plan, including interim monitoring guidelines, if necessary, also is incorporated.

I aid the investigators and data managers in determining which clinical data elements are required to address the hypotheses of the trial. This process may involve creating and reviewing data entry forms. After the trial opens and begins to accrue patients, I extract the data stored in study databases and provide an interim monitoring report per protocol guidelines. During this phase of the trial, I provide quality assurance and resolve any data discrepancies.

The next phase of the process occurs when the trial meets its accrual goal. Providing a comprehensive statistical report to the investigators, which includes statistical methodology as well as results and graphical displays of the data, is one of the tasks I relish. I extract data from databases, use statistical code in either SAS or S-Plus, and document statistical programs. Finally, I assemble the results and write a comprehensive statistical report with interpretation of statistical analysis. This report includes the statistical methods and results sections, to be included in the draft manuscript. The results presented in the statistical report are explained to the investigators and act as the foundation for the conclusions in the manuscript.

After the investigators prepare the full draft manuscript, I review it to ensure the conclusions accurately reflect the statistical results and critique the entire draft for internal consistency and quality.

My affection for mathematics began in the third grade. Some time during my middle-school years, I decided I would major in math when I attended college. As an undergraduate, I took several statistics courses and decided I wanted to pursue a master’s degree in statistics. I was doing what I loved: learning and statistics.
I enjoy working as a statistician in a cancer center for several reasons, including unveiling innovative medical advances to people in the community who are battling cancer and allowing them and their doctors to make informed decisions concerning treatment, working with brilliant PhD-level statisticians who are willing to provide guidance and take time to teach me new statistical procedures, and participating in a wide variety of tasks each day. In addition, I’m fond of the sense of respect and appreciation the Duke investigators express for my work.

The skills needed to succeed as a statistician in this academic environment include having a solid understanding of statistical methods and the ability to solve problems. One also must be accurate, organized, efficient, responsible, and self-motivated. Having the flexibility to work both independently and as part of a team also is valued.

Shortly after graduating with my master’s degree, I interviewed for my current job and thought it would be a good match for my interests and career goals. Now, 16 years later, I’m positive it’s an outstanding fit for me.
The highlights of my career include having the opportunity to use my strengths and interests to specialize in specific types of cancer, to use an array of statistical methodologies, to provide cutting-edge cancer treatment information to the community through medical journal publications, and to work with distinguished colleagues in both the medical and statistical fields, which broadens my knowledge every day.

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