Table 2. Pharmaceutical companies’ steps to promote model-based designsa.
| Company | Model-based designs | Key activities |
|---|---|---|
| AstraZeneca | All early oncology dose-escalation trials since 2014 | Education programme |
| Routine trial simulation software | ||
| Standard method for prior toxicity–response curves | ||
| All possible dose–response scenarios prepared for dose-escalation meetings | ||
| Roche Pharmaceutical Research and Early Development | Standard approach for oncology dose-escalation studies | Developed R software package, crmPack, for simulating, visualising, and running CRM studies |
| Joint scientific forums between statistical and medical colleagues | ||
| Examples of deployed designs | ||
| Boehringer Ingelheim | Standard approach for dose-finding (two-parameter Bayesian logistic regression model (Neuenschwander et al, 2008) with overdose control) | Expert statistics group provides support |
| Training for statisticians and non-statisticians | ||
| Template text for clinical trial protocols | ||
| Template R and SAS (SAS Institute Inc., Cary, NC, USA) programmes for protocols, steering committee meetings, and clinical trial reports |
Abbreviation: CRM=continual reassessment method.
a
Information provided by authors of this paper.