Table 3.
Variables with an impact on future R&D cost estimates. To what extent are these variables considered by the authors?
| Article | Role of public investment | Post-authorization R&D costs | Variations in regulation or approval times | Variations in the complexity of clinical trials or drug discovery |
|---|---|---|---|---|
| Wouters et al. [19] (2020) | 1 | 1 | 1 | 1 |
| Jayasundara et al. [40] (2019) | 1 | 1 | 1 | 1 |
| Årdal et al. [47] (2018) | 3 | 1 | 4 | 1 |
| Prasad and Mailankody [37] (2017) | 1 | 1 | 6 | 1 |
| DiMasi et al. [17] (2016) | 5 | 5 | 5 | 5 |
| Chit et al. [45] (2014) | 4 | 4 | 1 | 1 |
| Falconi et al. [50] (2014) | 1 | 1 | 1 | 1 |
| Sertkaya et al. [49] (2014) | 4 | 6 | 4 | 4 |
| Mestre-Ferrandiz et al. [48] (2012) | 4 | 4 | 4 | 4 |
| Adams and Brantner [51] (2010) | 1 | 1 | 1 | 1 |
| Paul et al. [52] (2010) | 1 | 4 | 3 | 1 |
| DiMasi and Grabowski [53] (2007) | 1 | 1 | 1 | 1 |
| Adams and Brantner [54] (2006) | 1 | 1 | 4 | 1 |
| DiMasi et al. [55] (2004) | 1 | 1 | 1 | 1 |
| DiMasi et al. [18] (2003) | 4 | 5 | 5 | 4 |
| Global Alliance for TB Drug Development [56] (2001) | 4 | 5 | 1 | 1 |
| Young and Surrusco [24] (2001) | 4 | 1 | 4 | 1 |
| DiMasi et al. [57] (1995) | 4 | 1 | 1 | 1 |
| DiMasi et al. [58] (1995) | 1 | 1 | 4 | 1 |
| DiMasi et al. [16] (1991) | 1 | 1 | 5 | 4 |
| Wiggins [59] (1987) | 1 | 1 | 6 | 6a |
| Hansen [60] (1979) | 1 | 2 | 5 | 1 |
Source: Authors’ elaboration
R&D research and development
6 indicates the main estimation of the R&D costs were adjusted by the variable; 5 indicates additional estimations (sensitivity analysis) were reported where R&D costs were adjusted by the variable; 4 indicates the authors state that the variable was relevant in the estimation of the R&D costs, but they were not able to adjust the R&D estimations (e.g., lack of information); 3 indicates the authors mentioned the variable, but without any link to the estimation of the R&D costs; 2 indicates the authors stated that the variable should not be considered in the estimation of the R&D costs; 1 indicates there was no mention of the variable in any part of the document. A detailed explanation of these categories is provided in electronic supplementary information 5
aNo increase in complexity was discussed; however, the authors included a parameter to capture the regulatory stringency in the previous years.