Generate dosing decisions (E, S, D or DU) of the 3+3 design for user-specified number of participants.
get_decision_3plus3(npts = 12)get_decision_3plus3() returns:
(1) a dataframe containing the decisions (E, S, D or DU) for each combination of y and n ($tab),
(2) a list ($setup) containing user input parameters, such as npts.
the number of participants within which dosing decisions are generated.
The 3+3 design uses the following decision rules.
(1). Start trial by treating three participants at the initial dose.
(2). Denote the dose level being used to treat participants as the current dose level. Treat three participants at the current dose level.
2a. If the maximum number of participants has been accrued, stop the trial. The MTD is inconclusive.
(3). Check the number of participants at the current dose level.
3a. If there are three participants, go to (4).
3b. If there are six participants, go to (5).
(4). Check the number of toxicities (among three participants) at the current dose level.
4a. If there are zero toxicities, escalate and go to (7).
4b. If there is one toxicity, stay at the current dose and go to (2).
4c. If there are two or three toxicities, declare that the MTD has been exceeded and go to (6).
(5). Check the number of toxicities (among six participants) at the current dose level.
5a. If there are zero toxicities, stop the trial and declare that the MTD is the current dose.
5b. If there is one toxicity, and the MTD has been exceeded, stop the trial and declare that the MTD is the current dose; otherwise, go to (7).
5c. If there are two or more than two toxicities, declare that the MTD has been exceeded and go to (6).
(6). The MTD has been exceeded.
6a. If the current dose is the lowest dose, stop the trial and declare that the MTD is lower than the lowest dose level.
6b. If then next-lower dose level has six participants, stop the trial and declare that the MTD is the next lower dose level; otherwise, the next lower dose level has three participants; set the current dose level to be the next-lower dose level and go to (2).
(7). Escalate if possible.
7a. If the current dose level is the highest dose level, stop the trial and declare that the MTD is the highest dose level.
7b. Otherwise, escalate to the next higher dose level and go to (2).
Storer B. (1989). Design and analysis of phase i clinical trials, Biometrics, 925–937.
Yang, S., Wang, S.J. and Ji, Y., (2015). An integrated dose-finding tool for phase I trials in oncology. Contemporary clinical trials, 45, pp.426-434.
get_decision_3plus3(npts = 12)
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