1. Economic Impact of Clinical Trials Management Process Improvement
L. Briones Carrillo 1
1 BIO.ROI® consulting, Madrid
lbriones@bioroi.com
return
on
investment
increased
clinical
trials
Enhancing
Efficient
management
Clinical trials
country competitive advantages
Material and Methods
It was calculated the investment to perform one international clinical trial In a realistic and conservative scenario and this unit cost applied to a 3 year win business
case. The hypothesis is the number of new international clinical trials involving the country that could be attracted enhancing competitive advantages as it would be
streamlining the trail activation phase.
assumptions
Per unit clinical trial specifications
3 years project duration
10 sites per project
6 subjects per site
6 Routine Monitoring Visits x site x year
5.000 € average Site grant x subject
2.000 € average drug cost x subject x year
assumptions
Per unit clinical trial specifications
3 years project duration
10 sites per project
6 subjects per site
6 Routine Monitoring Visits x site x year
5.000 € average Site grant x subject
2.000 € average drug cost x subject x year
supplies & third parties services
•Insurance
•Ethics Committee fees
•Regulatory Agency fee
•Courier for documentation
•Courier for biological sample
•Translations
supplies & third parties services
•Insurance
•Ethics Committee fees
•Regulatory Agency fee
•Courier for documentation
•Courier for biological sample
•Translations
employment
(*) FTE x project x year 3.3 FTE
Sponsor /CRO country resources 1,8 FTE
CRA, PM, LM, FV,Start-up
Sites resources 1,2 FTE
Investigator team,Study Coordinator, Nurse,
Pharmacist, Contract units, Ehics Committee
Third parties providers 0,3 FTE
Couriers, travel Agency, etc
Note: 1 FTE, Full Time Equivalent, is equal to 1 person working full time in a given role.
employment
(*) FTE x project x year 3.3 FTE
Sponsor /CRO country resources 1,8 FTE
CRA, PM, LM, FV,Start-up
Sites resources 1,2 FTE
Investigator team,Study Coordinator, Nurse,
Pharmacist, Contract units, Ehics Committee
Third parties providers 0,3 FTE
Couriers, travel Agency, etc
Note: 1 FTE, Full Time Equivalent, is equal to 1 person working full time in a given role.
Results
The Spanish regulatory agency, AEMPS, authorised 675 clinical trials in 2008, 444 were multi-country international
projects. The figures derived from the present work would represent an extra annual increase of 8%.
•Travels and accommodations
•Reprography
•Site and master files
•CRF printing
•Extra diagnostic tests
•Drug distribution
90 million €
economic activities
50 million €
prescription savings
452
new jobs
8.000 patients
early access to treatment
foreign investment
Total project unit investment 1,02 million €
Operations cost 35%
Site grants 30%
Medicine cost 35%
foreign investment
Total project unit investment 1,02 million €
Operations cost 35%
Site grants 30%
Medicine cost 35%
Conclusion
Economic and employment growth ratios allow the visualisation of process improvement actions and may support decision makers to undertake
key improvements with a high impact on economic return.
Eliminate the current delay due to contract management process would significantly streamline the activation phase of clinical trials. This would
be a relevant competitive advantage to increase country involvement in vanguard scientific international projects that not only allow patient early access to innovative
treatments but also bring foreign investment to biomedicine and biotech sector and health centers.
References
European Comission. Competitive and Innovation Framewok pProgramme (CIP). Enterprise and Industry. 2009:
http://ec.europa.eu/enterprise/
Ensayos clínicos con medicamentos autorizados en España durante 2007 y 2008. M. A. Serrano Castro et al. Medicina
Clínica. 2010;134(7):316–322
Memoria de actividades 2005 – 2006. Agencia Española de Medicamentos y Productos sanitarios.
MINT&RMINT&RMINT&RMINT&R----CECCECCECCEC is a initiative to improve the management of clinical trial contracts at national scope.
www.mintar.es
Objective.
To quantify the economic profit derived from achieving key competitive advantages in clinical trials management.
ROI
140 M €
452 jobs
8.000 patients
Potential
clinical trials
> 137 ~3 y.
it is worth trying!
streamline
activation
phase
DICTAME CEIC
CO TRATO + CDC
AEMPS
CO TRATO + CDC
AEMPS
DICTAME CEIC
137
extra clinical trials
3 years
140 million €
(tax not included)
foreign investment
business case
conservative scenario:
extra increase 137 international
clinical trials in 3 years
business case
conservative scenario:
extra increase 137 international
clinical trials in 3 years
business case 1st
year
2nd
year
3rd
year
Pharm a pull 45% 16 21 24
CROs pull 45% 16 21 24
Academia 10% 5 5 5
total 137 37 47 53