Limits and challenges of the ICH GCP requirements

Abstract

Since the publication of the Good Clinical Practice (GCP) (1991) there has been a progressive movement away from the initial interest in the protection of the rights of the subject, towards the formal guarantee of the completeness of the data, wrongly confused with “credibility”.

This causes conflicts and delays for ethical approval and appears to be due to the difference between the criteria used in drawing up the protocols in the pharmaceutical companies or the criteria with which some health authorities omit recommendations for performing clinical studies, and the criteria according to which the Ethics Committees should evaluate the protocol in order to guarantee real protection of the rights of the subject: conformity with the civil and penal law; compatibility with therapeutic practice and with medical ethics; appropriateness for the locally prevalent cultural, ethical, moral and religious conditions; respect for the principles of equal opportunities and justice for access to the study.

The GCP and other recommendations are considered only in this context. Neither the sponsor’s internal criteria (Standard Operative Procedures o SOPs), nor any different criteria that can be applied elsewhere are considered. It is therefore suggested to sponsors and to the authorities to incorporate this considerations in the protocols and recommendations; to remember that clinical research is above all a therapeutic action; that a protocol does not necessarily have to be identical everywhere, as long as its integrity is respected.

The less important elements have to allow for adaptation according to the specific local characteristics. This suggests limiting the present practice of centralizing the procedures of drawing up and providing ethical approval of the protocols, leaving greater autonomy to the local operative reality.