Bayer conducts clinical trials in accordance with the international guidelines, the current national and local laws and regulations and the highest medical, scientific and ethical principles.
The internal processes for the planning and conduct of clinical trials are implemented by Bayer worldwide – regardless whether studies are conducted in Europe, the USA, or in other countries.
To ensure that all guidelines are strictly followed and implemented, Bayer has in place an extensive quality system and quality standards.
A clinical study is conducted according to a research plan known as the study protocol. The protocol is designed to answer specific research questions as well as to safeguard the health of participants. It contains information on the reason for conducting the study, who may participate in the study (the eligibility criteria), the number of participants needed, the schedule of tests, procedures, or drugs and their dosages, the length of the study, and what information will be gathered about the participants of the clinical trials.
Finally, a standardized procedure followed worldwide by pharmaceutical companies such as Bayer is the signature of the informed consent document by the trial participants. This process makes sure that potential clinical trial participants understand the risks of, potential benefits of, and alternatives to the study. This document must be signed before entering a study to show that the patient (or their legal representative) was given information on risks, potential benefits, and alternatives, understands it and agrees to participate as well as to the use of his personal data related to the study. Signing the document and providing consent cannot be considered to be a contract. Participants may withdraw from a study at any time, even if the study is not over, and at no detriment to their future standard medical care.
The key role of Ethics Committee
Before initiating a clinical study, besides formally submitting to regulatory agencies in all countries involved, Bayer is bound to seek written approval from Ethics Committees, also referred to as Institutional Review Boards.
The Ethics Committee considers ethical, legal and scientific aspects together with the benefit/risk profile of the proposed trial when deciding on approval. The Ethics Committee consists of members from a broad range of disciplines and acts as an independent review body, completely separate from the pharmaceutical company that is sponsoring the trial. As part of its review process, the Ethics Committee also evaluates if the proposed facility or institution, together with the clinical researcher, are suitably qualified to conduct the planned research study.
The workings and procedures of the Ethics Committees are subject to inspection at any time by the responsible Health Authorities.
Selection of clinical study centers
When selecting countries and clinical study centers, Bayers primary considerations include medical and regulatory aspects as well as the respective countrys medical infrastructure. This ensures that the investigating physicians bring the best medical and scientific expertise to the study. This approach also takes into account that efficacy and tolerability of medicines sometimes vary in different ethnic groups owing to differences in the way the drug is metabolized.
Further, some Health Authorities may require that clinical trials include sites within their own country if a pharmaceutical company is seeking market approval of a new drug application.
Quality System and Quality Standards at Bayer
- All necessary clinical development processes, which must be adhered to globally, are described in detail in Bayer‘s extensive Quality System. Patient safety, transparency of the clinical trial process and clinical data integrity are the cornerstones of our Quality System.
- Through our internal process known as monitoring, Bayer as the sponsor of the clinical trial works with clinical research sites to ensure adherence to the agreed trial protocol, that the protection of subjects is safeguarded and that the data generated is complete and accurate.
- All aspects of the clinical development activities of Bayer are audited by Bayer‘s Quality Assurance group which works independently from the Clinical Development function.
The results of these audits provide management with assurance of the reliability and integrity of clinical data, and that it has been generated in adherence to Bayer‘s strict standards and applicable laws.
Main International Standards of Ethical Practice
The Declaration of Helsinki: in place since 1964 and now in its 7th version. This declaration is considered the worldwide standard for ethics in clinical research on people.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use – ICH-GCP: in place since 1996. It defines internationally recognized, ethical and scientific standards when planning, conducting, documenting and reporting on clinical studies with humans.