The research and development (R&D) process is at the heart of Lilly’s mission to provide innovative medicines that enable people to live longer, healthier, and more active lives. During 2008, we spent $3.8 billion on R&D – an increase of 10 percent compared to 2007 – representing 18.8 percent of sales.
Discovering new drugs through pharmaceutical R&D is a complex and lengthy process. To demonstrate the safety and efficacy of a drug, by law it must be tested in the laboratory, in living cells and organisms, in laboratory animals, and finally, in humans. We recognize that we have an ethical and scientific obligation to ensure the appropriate and humane treatment of animals used in research and have systems in place to fulfill this obligation.
Conducting clinical research ethically is consistent with our mission and values. By nature, there are risks inherent to pharmaceutical research on human subjects. Lilly has established policies, standards, and protections throughout the R&D process to ensure that patient needs are foremost at all times.
Protecting patient safety during the R&D process begins with our Principles of Medical Research, an overarching statement about how and why Lilly conducts research, the company’s relationship with researchers, and how it shares research and development results.
Lilly applies a single global standard to the conduct of clinical trials. Specifically, we adhere to the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with good clinical practices and applicable laws and regulations of the country or countries where the study is being conducted. We also follow standards published by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, the International Ethical Guidelines for Biomedical Research Involving Human Subjects, and the Pharmaceutical Research and Manufacturers of America Principles for Conduct of Clinical Trials.
Taken together, these principles and standards set forth rules that companies should follow to protect the safety of research participants and the integrity of the research enterprise.
Applicable wherever research is conducted, these principles and standards are reflected in our informed consent documents, which require a signature by every patient or volunteer who wishes to participate in Lilly-sponsored research. Lilly informed consent documents clearly state the risks associated with voluntarily participating in clinical trial research. Our bioethics program has also developed complementary positions on clinical trial matters and procedures to help researchers access thoughtful, informed advice on ethical questions.
