Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 27

The regulatory environment within which human biomedical clinical trials are conducted is a matrix composed of: (i) the policies, laws, and regulations which describe the requirements and guidance; (ii) the governmental jurisdictions (Federal, State, Country, Region e.g. EU) which are responsible for implementing the requirements through regulatory authorities; (iii) nongovernmental organizations, e.g. Academic Medical Centers (AMCs), which both sponsor clinical trials and set their own internal standards for how clinical trials will be conducted; and (iv) the professional organizations (e.g. WHO, WMA) which support, define, and interpret the requirements, standards, and guidelines for their professional members.

It is not always clear whether this matrix works together under a planned scenario but the end result is that if a commercial sponsor, medical establishment, or individual practitioner wishes to conduct experimental biomedical studies in humans, that activity receives considerable oversight and review. There are complexities which the regulatory environment matrix introduces to the conduct of clinical trials; therefore it is important to understand the makeup of the regulatory environment. For example conducting trials in conformance with ICH E6(R2) does not guarantee that a trial meets all of the applicable regulatory standards called for by the country or region where the study is performed but it is probable that the use of the those guidelines would ensure that 90% or more of applicable requirements will be met.

Let us begin the examination of the regulatory environment by reviewing each of the four part matrix as depicted in Figure 2.1.