Trial Arms for Dose escalation studies

Pinnacle 21 Support SDTM
1

I’ve seen some companies create way to many trial arm records to handle this. It seems the concept of Panel for dose escalation inflated the number of arms. I would view wach panel as an ARM, but in the TA domain, the records seeme d multiplied by panel x period.

I would also like to know what the standard practice is. Should you find a good answer outside our forum, please share the answer with us.

2

Yes, we are also following to assign separate arm for each dose level.

Surely i will post if find a better way.

Thanks

3

I like to think an ARM is a distinct path a patient can take throughout the trial. And that dose escalation is similar to crossover.

The SDTM IG 3.2 does make this statement on page 306 of 398. So without formal guidance, the sponsor is on their own.

The current Trial Design Model has limitations in representing protocols, which include the following:

  • plans for indefinite numbers of repeating Elements (e.g., indefinite numbers of chemotherapy cycles)
  • indefinite numbers of Visits (e.g., periodic follow-up Visits for survival)
  • indefinite numbers of Epochs
  • indefinite numbers of Arms

The last two situations arise in dose-escalation studies where increasing doses are given until stopping criteria are met.

  • Some dose-escalation studies enroll a new cohort of subjects for each new dose, and so, at the planning stage, have an indefinite number of Arms.
  • Other dose-escalation studies give new doses to a continuing group of subjects, and so are planned with an indefinite number of Epochs
4

Hi

For the dose escalation studies i.e for the same drug different dose levels for different coherts, how the arms should be assigned.

Should we consider as only one arm, or else each dose level should be treated as separate arm.

And how would be the elements.