Research & Development
Lilly creates and delivers innovative medicines that enable people to live longer, healthier, and more active lives. Lilly carefully conducts medical research to generate important information regarding those medicines and promotes them for the indications for which they have been approved. Lilly sponsors and supports medical research for the purpose of answering scientific questions that are important and relevant to its customers.
- Lilly thoughtfully aligns its medical research and marketing activities to provide "answers that matter" to its customers.
- Lilly does not use its medical research as a means to circumvent laws regarding the promotion of its products and complies with the highest ethical principles regarding the proper relationship between medical research and marketing and sales.
- Lilly does not conduct medical research with an intent that the mere conduct of the study itself induce the sale of a Lilly product.
- Lilly may conduct off-label medical research for the purpose of answering important and relevant scientific questions, but does not conduct such research to induce the sale of a Lilly product for off-label use.
- 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.
In order for biopharmaceutical innovators like Lilly to effectively discover and bring new drugs to market, we must be able to operate in a predictable and transparent regulatory environment. Issues of interest to Lilly include:
- Enabling patient-focused drug development by together considering the benefits and risks of medicines and weighing them against the benefits and risks of not treating or not preventing the condition.
- Supporting the capacity of regulatory bodies to adequately address drug approval submissions that propose to use biomarkers to better establish and identify patients who are predisposed to experience benefits or adverse events from using a new medicine.
- Enabling the use of patient reported outcomes (PROs) in clinical trials through early consultation between regulators and innovators to make sure endpoints are well defined and reliable.
- Fostering efficient and effective drug development through timely and interactive conversations between industry and regulators.