Table 3 Criteria for potential new research arms
· | Sound rationale, including a robust biological hypothesis and compelling evidence of activity that strongly identifies a need to assess a research approach in the setting studied. |
· | Positive evidence of mechanisms or synergy of action (or both) in the disease area |
· | Investigator enthusiasm for the new research arm. |
· | Pharmaceutical research agents would need to be licensed or be close to being licensed at the time of activation. Without a licensed use for the drug (usually in later disease), data in the target setting are likely to be of limited value. |
· | Relevant industry partners willing to collaborate and contribute to the trial, if the research arm is a pharmaceutical agent. |
· | Successful independent peer review as for a new study. |
· | Recruitment to new arm must not jeopardise completion of the ongoing research arms, e.g. by diluting recruitment excessively. This means that the accrual rate must be better than predicted in the original trial or that other research arms have already stopped accrual early. STAMPEDE is presently recruiting at around 700 patients/year when 500 patients/year were targeted. This permitted capacity to consider new research agents even while all original arms remained open. |
· | The new comparison must still be relevant when it matures. |