Table 1 Evidence on the economic impact of Clinical Trials
Ref. ID | Country | Therapeutic Area | # of trials | Phase | # of patients | Year(s) | Cost items included (medicines, diagnostics, side effects, trial management, others) | Methods (clinical trial data / clinical trial protocol / mixed) | Main findings (total cost avoided / mean cost avoided per patient recruited) |
|---|---|---|---|---|---|---|---|---|---|
[24] | Australia | Haematology | 36 | I, II, III | 245 | 2006-2017 | Medicines | Clinical trial data | €4,278,116 total cost avoided |
[25] | Austria | Multiple | 1,029 | I, II, III, IV | 23,331 | 2012-2017 | Medicines, diagnostics, side effects, others | Clinical trial protocol | €100.5mi saved annually |
[26] | Canada | Cancer | 21 | III | 4,674 | 1999-2011 | Medicines, diagnostics | Clinical trial protocol | The total Drug Cost Avoidance (DCA) was estimated at €20,308,422 of which targeted therapy constituted 43 % (five trials). The combined Pathology Cost Avoidance (PCA) and DCA was €23,356,118 for a cost avoidance per patient of €5,447.83 |
[27] | Canada | Cancer | 37 | I/II, II, III | 250 | 2001-2006 | Medicines | Clinical trial protocol | Drug specific cost avoidance per patient: €7.99 - €169,885.51 |
Potential drug specific cost avoidance per patient: €9.62 - €195,000.48 | |||||||||
Actual drug cost avoidances according to tumour group were calculated showing a median range of €936.74 - €16,157.14 per patient between tumour groups. The median range for potential drug cost avoidance was substantially higher from €6,712.93 - €31,727.89 per patient | |||||||||
[28]0 | Canada | Breast cancer | 8 | III | 97 | 2006-2009 | Medicines, diagnostics, trial management, others | Clinical trial data | Mean additional total costs between CT and SoC patients of €4,601 (95 % confidence interval: €94 - €9,109 p=0.046) |
[29] | France | Oncology - Haematology | 27 | III | 177 | 2011-2016 | Medicines | Mixed | Total cost savings were €5.2mi |
Mean cost saving per patient was €19,182.7 ± €29,865.7 | |||||||||
[23] | Germany | Oncology | 88 | Un-specified | Un-specified | 2002-2005 | Medicines | Mixed | €5.1mi potential drug cost savings |
€1.5mi actual drug cost savings | |||||||||
[30] | Italy | Lung cancer | 12 | Un-specified | 44 | 2010 | Medicines, diagnostics | Clinical trial contract | €243,154 drug cost savings |
[31] | Italy | Oncology | 34 | I, II, III | 126 | 2017 | Medicines | Clinical trial protocol | Average hospital saving of €5,487 per patient treated in pharma sponsored studies and €206 for investigator-led studies |
€517,658 in a month for drugs that otherwise would have been loaded on the Italian National Health Service | |||||||||
[32] | Italy | Oncology - Haematology | 29 | II, III | 189 | 2011-2016 | Medicines | Mixed | Total avoided costs of €330,000 |
Potential total avoided costs at national level would range from 320 to 360 million €/year | |||||||||
[33] | Spain | Lung cancer | 12 | I, II, III | 69 | 2016 | Medicines | Clinical trial data | The overall avoided cost was €474,428.65. The average cost per clinical trial was €39,535.72 and per patient was €6,875.77 |
[34] | Spain | Prostate cancer | 5 | III | 136 | 1996-2013 | Medicines | Clinical trial data | €696,002 total cost avoidance |
€139,200 average cost avoidance per clinical trial | |||||||||
€5,118 average cost avoidance per patient | |||||||||
[35] | Spain | Breast cancer | 37 | I, II, III | 89 | 2014-2016 | Medicines | Clinical trial protocol | 80 % of cost savings were derived from phase III trials |
€957,246 total cost avoidance | |||||||||
€10,756 average cost avoidance per patient | |||||||||
[36] | Spain | Oncology | 38 | Un-specified | 261 | 2017-2018 | Medicines | Clinical trial (unspecified) | Avoided cost: €3,482,662 / year; €13,343/patient |
[37] | Taiwan | Multiple | 194 | I, II, III, IV | 2,883 | 2008 | Medicines | Clinical trial data | Average cost avoidance of €39,456/trial-year or €26,531/participant-year |
[38] | Turkey | Multiple | 174 | I, II, III, IV | 1,437 | 2006-2010 | Medicines | Clinical trial data | €212,478,657 government saving |
[39] | UK | Oncology | 53 | II, III | 357 | 2009-2010 | Medicines, diagnostics, trial management, others | Clinical trial protocol | €436,763 (2009) and €344,833 (2010) overall treatment cost savings |
[40]* | USA | Multiple | 6,199 | 0, I, II, III, IV | 1,100,000 | 2013 | Medicines, diagnostics, trial management, others | Clinical trial data | Estimates of Overall Economic Impact of Industry-Sponsored Clinical Trial Activities at U.S. Trial Sites 2013 |
Direct – Research activities at clinical trial sites around the country €7.4 bn | |||||||||
Indirect and Induced – Vendors and suppliers to trial sites; Consumer purchases by researchers and workers engaged in or supporting the clinical trial process €11.4 bn | |||||||||
Total €18.8 bn | |||||||||
[41]§ | USA | Lung cancer | 4 | III | 31 | 2017 | Medicines, diagnostics, trial management, side effects, others | Clinical trial data | The mean cost to treat an event of grade 3 nausea was €12,135 |
The mean costs to treat an event of grade 3–4 thrombocytopenia combined excluding and including hospitalization costs were €544,885 (SD = €1,283.15) and €3,678 (SD = €8,418.80) respectively | |||||||||
[22] | USA | Oncology and AIDS | 255 | Un-specified | 756 | 1996-97 | Medicines | Clinical trial data | €2.7 mi cost avoidance in drug costs |
[21] | USA | Multiple | 107 | Un-specified | Un-specified | 2000-2002 | Medicines | Mixed | Mean drug cost avoidance €2,417,117 per year |