14.Randomization11.Master observation trial - sporedata/researchdesigneR GitHub Wiki

1. Use cases: in which situations should I use this method?

The Master Observational trial is a precision medicine type of protocol that combines a molecular approach to a given intervention with real-world data.

2. Input: what kind of data does the method require?

3. Algorithm: how does the method work?

Model mechanics

Describing in words

Master observation trials specify the basic infrastructure behind a series of trials. The concept is similar to an assembly line, where the infrastructure and people remain the same while new interventions are added over time.

Describing in images

Describing with code

Breaking down equations

Reporting guidelines

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials [1].

Data science packages

Suggested companion methods

Learning materials

Books *
Articles
- The Master Observational Trial: A New Class of Master Protocol to Advance Precision Medicine [2].
- Common references for randomized designs.
SporeData-specific

4. Output: how do I interpret this method's results?

Mock conclusions or most frequent format for conclusions reached at the end of a typical analysis.

Tables, plots, and their interpretation

5. SporeData-specific

Templates

Data science functions

References

[1] Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. Jama. 2017 Dec 19;318(23):2337-43.

[2] Dickson D, Johnson J, Bergan R, Owens R, Subbiah V, Kurzrock R. The Master Observational Trial: A New Class of Master Protocol to Advance Precision Medicine. Cell. 2020 Jan 9;180(1):9-14.