Chang Yu's Ideas

To add to Dan's question list, here are some specific areas statisticians can help with the CTSA application. I think CTSA presents great opportunities for the department and the question for us is how we can integrate our departmental goals into the CTSA objectives. More questions:

1) biostatistical support and collaboration in the CTSA:

Should we push to move away from the current "statisticians as the reviewers/consultants" model at the GCRC to a more active, such as percent effort on each protocol, collaborative model in the CTSA?

How might the expanded biostatistical support in the CTSA potentially impact our collaborative plans with other departments, since investigators could come to the CTSA for statistical help?

Do we want to propose a standing DSMB in the CTSA? (one of the CTSA emphases: patient safety and ethical conduct of research)

At one point, a Data Coordinating Center in the CTSA was mentioned; do we want to include that in the biostatistics component of the CTSA? (one of the CTSA goals: interaction with government agencies and the industry)

2) biostatistics education in the CTSA

One of the CTSA goals: "education leading to advanced degrees in clinical research" Could we integrate our MS and PhD programs into this? This leads to a bigger question, how are we going to shape our MS program? Follow the one like in University of Minnesota, or to modify that to fit into the CTSA goals?

Do we want to work with Dr. Nancy Brown to expand our involvement at the MSCI program, e.g. to add courses such as experiment design, clinical trial, clinical data management, statistical package with a focus on R to their curriculum?

3) professional development for CTSA statisticians

This is another justification for the 5 FTE's.

With this added resource in biostatistics, it would make it possible for statisticians to developed novel statistical methods for non-conventional data analyses. That would enhance professional development for statisticians in the Center, as well as helping investigators.

Following this, we want to mention research efforts on statistical methods for biomarker studies, adaptive design for clinical trials, surrogate endpoints, non-conventional (FDA would not like) design for clinical trials…… any other ideas besides conventional biostatistical research?

Do we want to propose 20% protected time for CTSA statisticians so that the department does not have to cover that? Goggle even provides that to its employees!

Add the above up, without the Data Coordinating Center, 5 FTE's are barely enough.
Topic revision: r2 - 26 Apr 2013, JohnBock

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