Inspeção em boas práticas clínicas: uma proposta de guia para a ANVISA

Abstract

Due to atrocities in the past related to drug problems, such as thalidomide and sulfanilamide syrup episodes, or the lack of ethics in conducting experiments with humans, such as during the Second World War, there was a need to define minimum criteria to ensure medicines with quality, safety and efficacy, in addition to ensuring the ethical protection of participants in clinical trials. Among several measures adopted around the world, one of the most important was the establishment of Good Clinical Practices (GCP) guidelines, which is based on standardizing the conduct of clinical trials to ensure that the data and results reported have credibility and accuracy and that the rights, integrity and confidentiality of clinical trials participants are protected. GCP inspections conducted by regulatory agencies are aimed at verifying compliance with GCP at facilities conducting clinical trials, such as clinical trial sites, sponsors, and Clinical Research Organizations (CRO). In Brazil, there is currently no guide or regulation that describes in detail the items that are evaluated during a GCP inspection conducted by Anvisa, although there are general guidelines described in the GCP guides as “Documento das Américas” and E6 of International Council for Harmonization (ICH) and a Normative Instruction nº 20 of 2017 has been published with the general activities carried out during an inspection by Anvisa. In this way, the proposal of this project was to elaborate a guide of inspection in GCP in clinical trial sites and one of inspection in GCP in sponsors / CROs, describing how the inspections are conducted by Anvisa and what items are verified during its conduction. It is expected that these documents are able to assist those involved with clinical research in the compliance of GCP and of regulatory requirements. The guides were prepared from a bibliographical review of all the inspection guides available in the signatory countries of the “Documento das Américas” and ICH. In addition, the text of the guides has been improved after consulting reports with results of inspections carried out by international regulatory agencies and after internal contributions from Anvisa and external contributions of the associations involved in clinical research. It is expected that with the publication of these inspection guides, clinical trials in Brazil will be conducted in a standardized way, ensuring an improvement in the quality of their conduction, in addition to bringing greater transparency in relation to regulatory requirements, reducing subjectivity in the interpretation of the guidelines for conducting clinical trials.