Most industries globalise to reduce costs: Cost is not, however, the primary driver for the globalisation of clinical research: Low site fees currently are offset by high communication and logistics costs. The primary attraction is generally subject availability. As a side benefit, data quality is better in many developing countries than in developed countries. The multiplicity of legal and regulatory regimes offsets these advantages, and can be serious problems in multinational trials. Clinical trial agreements are a small area of the legal and regulatory impact that will grow in importance as globalisation of the industry continues. In the United States, it takes clinical trial sponsors an average of 35 days to negotiate clinical trial agreements (CTAs) with community-based sites and site management organisations, and 96 days with academic centers.1 Investigative sites have ranked ÔLegal ReviewÕ and ÔContracts & BudgetsÕ higher than ÔSubject Recruitment Õ as a source of delay for clinical trials.2 New drugs can generate revenue of over USD1 million per day, so the cost of these delays adds up quickly. In addition, most new drugs enjoy patent exclusivity for only a few years at best, so time is of the essence.
In the United States, some of the delays occur when the sponsor is in one state and the site is in another. The difficulties are
magnified when the sponsor or site is outside the United States. It is magnified further when sites are in multiple countries.
It is magnified further when sites and sponsors on multiple trials are in multiple countries. It is magnified still further when
sites and sponsors are in multiple states and provinces within multiple countries. With the steady globalisation of clinical
research, these difficulties will become ever more burdensome.
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Published in Research Global