Research provides the foundation for advances in medicine and for the development of innovative therapies. Bayer, as a research-based pharmaceutical company, focuses on the discovery and development of new treatment options for diseases with a high unmet medical need.
Clinical studies represent an important part of the drug development process. They are an indispensable tool to determine the safety and efficacy of new drug candidates before they can be used to treat illness. The benefits and potential risks of new medicines must always be scientifically proven and well-documented.
The role of ethics in clinical studies
The ethics of research on people and clinical trials is an area of public concern and interest. Pharmaceutical companies that conduct such research have been subject to criticism for a lack of transparency. A further line of criticism suggests that studies with approved and launched products are mainly undertaken for marketing purposes, or are conducted abroad in an effort to cut costs or avoid strict regulations.
Ethical conduct in clinical trials is based on the Helsinki Declaration, an ethical standard in place since 1964 which governs research on people. Since then, supplementary standards, regulations and ethical codes have been further developed and introduced worldwide to ensure that safety and well-being of patients remain paramount in clinical studies.
All companies performing clinical development have to follow the international standards and need to obtain approval from a number of governing international authorities.
Ethics in clinical research at Bayer
At Bayer, research on people is conducted according to the highest medical, scientific, and ethical principles. Utmost attention is paid to the patient’s well-being, dignity, safety and rights. All studies at Bayer adhere to strict international guidelines and quality standards as well as current national laws and regulations. Bayer sets high standards on designing clinical studies allowing a high degree of transparency.
In line with these goals, the “Trial Finder” database of Bayer contains publicly available information on clinical trials sponsored by Bayer, and is provided for patients, healthcare professionals and the broad public to increase the transparency of Bayer's clinical research.
In May 2014 Bayer joined the portal clinicalstudydatarequest.com granting access to anonymized patient-level data of Bayer sponsored clinical studies to researchers and in this way helping to advance medical science and improve patient care.
Bayer is fully committed to disclosing information about our planned and ongoing clinical trials. Bayer will also make results of trials in patients public and provide free access to this information on the internet.
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.
Bayer follows the strictest scientific and ethical principles, always in accordance with applicable law, when carrying out research on humans – especially when it comes to patient recruitment.
Access to Investigational Medicines
An investigational medicine is one that has not yet been approved for use. Access for patients in need can be granted based on certain criteria.