Basket study

Source: [4].

«Basket trials (or studies) test the effect of one drug on a single mutation in a variety of tumor types [baskets], at the same time. These studies also have the potential to greatly increase the number of patients who are eligible to receive certain drugs relative to other trials designs [1], «allowing researchers to analyze each cancer type individually, as well as assess the impact of the drug or drug combinations as a whole. Using this approach, it is possible to combine what would have been multiple phase 2 trials into a single study [4]». «In the evaluation of targeted therapies, basket trials have emerged as an approach to test the hypothesis that targeted therapies may be effective independent of tumor histology, as long as the molecular target is present [2].» «Most basket trials typically aim to answer multiple questions simultaneously [3].»

Bibliographic references:
[1] Clinical Trial Design and Methodology. ASCO. https://www.asco.org/research-progress/clinical-trials/clinical-trial-resources/clinical-trial-design-and-methodology. Accessed August 18, 2018.

[2] Redig AJ, Jänne PA. Basket trials and the evolution of clinical trial design in an era of genomic medicine. J Clin Oncol. 2015 Mar 20;33(9):975-7. Available at: https://doi.org/10.1200/JCO.2014.59.8433.

[3] Cunanan KM, Gonen M, Shen R, et al. Basket Trials in Oncology: A Trade-Off Between Complexity and Efficiency. J Clin Oncol. 2017 Jan 20;35(3):271-273. Available at: https://doi.org/10.1200/JCO.2016.69.9751.

[4] Illuminating ideas: Innovative clinical trial design. Roche.com. https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/innovative-clinical-trial-design.htm. Accessed August 18, 2018.