Practical issues in conducting multinational, multicenter trials managed by Contract Research Organisations

1994 ◽  
Vol 9 (3) ◽  
pp. 151-153
Author(s):  
M Placchi
Keyword(s):  
Drug Therapy ◽  
Therapeutic Agent ◽  
Clinical Development ◽  
Phase Iii ◽  
Contract Research ◽  
Multicenter Trials ◽  
Practice Organization ◽  
Research Organisations ◽  
Joint Evaluation ◽  
Contract Research Organisations

Large multinational, multicenter trials are increasingly being performed during Phase III of the clinical development of a psychotropic drug to demonstrate the efficacy of the new therapeutic agent in the shortest possible time. The testing of the new drug therapy under a common protocol, foreseeing the combination of clinical data collected across countries for a joint evaluation, is becoming more frequent in drug development. Usually, Sponsors use the services of Contract Research Organisations (CROs) to undertake and manage such large multinational, multicenter trials.The Sponsor who is setting up large definitive CRO-managed studies with psychotropics may anticipate to encounter issues along the following lines: Psychiatric Practice, Organization and Logistics, Data Integration and Manpower.

scholarly journals Collaboration between academics and industry in clinical trials: cross sectional study of publications and survey of lead academic authors

BMJ ◽  
2018 ◽  
pp. k3654 ◽  
Author(s):  
Kristine Rasmussen ◽  
Lisa Bero ◽  
Rita Redberg ◽  
Peter C Gøtzsche ◽  
Andreas Lundh
Keyword(s):  
Internal Medicine ◽  
Data Analysis ◽  
High Impact ◽  
Phase Iii ◽  
Industry Funding ◽  
Cross Sectional ◽  
Contract Research ◽  
Research Organisations ◽  
Academic Authors ◽  
Contract Research Organisations

Abstract Objectives To determine the role of academic authors, funders, and contract research organisations in industry funded trials of vaccines, drugs, and devices and to determine lead academic authors’ experiences with industry funder collaborations. Design Cross sectional analysis of trial publications and survey of lead academic authors. Eligibility criteria for selecting studies The most recent 200 phase III and IV trials of vaccines, drugs, and devices with full industry funding, at least one academic author, published in one of the top seven high impact general medical journals ( New England Journal of Medicine , Lancet , JAMA , BMJ , Annals of Internal Medicine , JAMA Internal Medicine , and PLoS Medicine ). Results Employees of industry funders co-authored 173 (87%) of publications; 183 (92%) trials reported involvement of funders in design, and 167 (84%) reported involvement of academic authors. Data analysis involved the funder in 146 (73%) trials and the academic authors in 79 (40%). Trial reporting involved the funder in 173 (87%) trials and academic authors in 197 (99%). Contract research organisations were involved in the reporting of 123 (62%) trials. Eighty (40%) of 200 lead academic authors responded to the survey. Twenty nine (33%) of the 80 responders reported that academics had final say on the design. Ten responders described involvement of an unnamed funder and/or contract research organisation employee in the data analysis and/or reporting. Most academic authors found the collaboration with industry funder beneficial, but 3 (4%) experienced delay in publication due to the industry funder and 9 (11%) reported disagreements with the industry funder, mostly concerning trial design and reporting. Conclusions Industry employees and academic authors are involved in the design, conduct, and reporting of most industry funded trials in high impact journals. However, data analysis is often conducted without academic involvement. Academics view the collaboration as beneficial, but some report loss of academic freedom.

scholarly journals Big-pharmaceuticalisation: Clinical trials and Contract Research Organisations in India

2015 ◽  
Vol 131 ◽  
pp. 239-246 ◽  
Author(s):  
Salla Sariola ◽  
Deapica Ravindran ◽  
Anand Kumar ◽  
Roger Jeffery
Keyword(s):  
Clinical Trials ◽  
Contract Research ◽  
Research Organisations ◽  
Contract Research Organisations

scholarly journals Putting contract research organisations on the radar

2012 ◽  
Vol 9 (2) ◽  
pp. 32-34
Author(s):  
Mariëtte van Huijstee ◽  
Nuria Homedes
Keyword(s):  
Clinical Trials ◽  
Third Parties ◽  
Pharmaceutical Companies ◽  
Middle Income ◽  
Contract Research ◽  
Middle Income Countries ◽  
Research Organisations ◽  
Contract Research Organisations ◽  
Low And Middle Income

There is a trend for pharmaceutical companies to contract third parties to conduct the clinical trials that are needed to test their drugs. This trend is referred to as outsourcing, and the companies that carry out the work are called contract research organisations. In addition, clinical trials are increasingly conducted in non-traditional trial regions, which are mainly low-and middle-income countries. This trend is called offshoring. The combination of outsourcing and offshoring poses serious risks for the ethical treatment of participants in clinical trials.

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