04.Data collection08.Platform trials - sporedata/researchdesigneR GitHub Wiki

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

Platform trials use the same infrastructure (patient population, sites, case report form [CRF] templates, institutional review boards [IRBs], or ethical committees) across different trials. Using this platform eases the costs of establishing a new study, also increases the speed of completion. The main challenge behind a platform trial is to continuously feed the platform with new studies.

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

  1. Presence of a group of trial sites with access to a specific population, willing to conduct sequential trials, and consistently delivers in terms of recruitment and data quality.

3. Algorithm: how does the method work?

Model mechanics

Reporting guidelines for Methods

  • Same as the ones present in individual trials.

Data science packages

  • Same as the ones present in individual trials.

Suggested companion methods

  • Bayesian Adaptive Trials are especially appropriate for platform trials as they can connect different trials through priors, allow for multiple interim analyses without p-value penalties, and also decrease the sample size of individual studies.

Learning materials

  1. Books

  2. Articles combining theory and scripts

Resources

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.

  • Conclusions are identical to individual trials, although questions tend to be somewhat connected one to the other

Tables, plots and their interpretation

  • Same as the ones present in individual trials.

References

[1] Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Annals of internal medicine. 2013 Feb 5;158(3):200-7.

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