Glossary

Academic Research Organization (ARO): An academic organization engaged to coordinate the management and performance of a clinical study and which may assume responsibility for certain regulatory obligations of the pharmaceutical company under applicable federal regulations. An ARO may often serve in the role of principal investigator and lead author for the study results.
Business Meals: Any food or beverage provided to a physician, including meals provided at a physician’s office, hospital, conference, or other business event.
Business Travel and Other Value: Business travel includes reasonable travel expenses, such as airline tickets, other transportation, and hotel accommodations, provided for or reimbursed to a physician when they are performing services on behalf of Lilly. Other value includes non-cash items or services, such as educational items, given to a physician, that are primarily intended for the benefit of the physician.
Clinical Study Phases: Phase I – Investigates the safety of a molecule, how it behaves in the human body and possible side effects in a small number of healthy people who typically do not have the disease.
Phase II – Investigates a molecule’s efficacy and short-term side effect profile in a small number of patients who have the disease.
Phase III – Seeks definitive proof of a molecule’s efficacy and safety profile in a large global patient population. These multi-centered studies usually involve hundreds to thousands of patients.
Phase IV – Post-marketing studies may be requested by the FDA to provide additional data, or be initiated by Lilly to expand labeling to other indications or patient populations.
Corporate Integrity Agreement (CIA): In 2009, Lilly entered into a corporate integrity agreement with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). This agreement requires Lilly to maintain its compliance program and to undertake a set of defined corporate integrity obligations for five years.
Educational Programs: These are expert-led speaker programs designed to educate patients and other health care professionals. Speakers address such topics as treatment options, patient care, a medicine’s effectiveness, side effects, safety history, and disease state education.
Fair Market Value: Fair market value within this site applies to the amount of compensation paid to a health care professional for services provided to Lilly that is within a reasonable range of what the health care professional would earn from others for similar services.
Health Care Professional: Any individual who provides health-related services to patients or is involved in the research, support, or delivery of health-related services, including physicians, nurses, researchers, scientists, nurse practitioners, physician assistants, and others.
Investigator-Initiated Trials: Research, independently proposed and conducted by institutions, physicians, and researchers, that seeks to advance medical and scientific knowledge. While not proposed by Lilly, Lilly is often approached to provide funding for these types of studies.
Lilly Faculty Registry: In 2009, Lilly voluntarily launched the Lilly Faculty Registry, an online listing of payments made to external U.S. health care professionals contracted to perform educational programs and provide us with advice based on their experience and expertise. The Lilly Faculty Registry has been replaced with the Lilly Physician Payment Registry as our payment disclosures changed in 2011 to include payments and non-cash value to all U.S. physicians.
Other Services: Physicians provide insights and recommendations on a variety of non-research related topics. For example, Lilly relies on physicians' expertise to develop educational and marketing materials that resonate with patients, to assist in complex data analysis, and to evaluate changes in treatment and care that are relevant to the patient.
PhRMA Code: This “Code on Interactions with Health Care Professionals” from Pharmaceutical Researchers and Manufacturers of America (PhRMA) and its member companies reflects a commitment to working with health care professionals for the benefit of patients. The PhRMA Code starts with the fundamental principle that a health care professional’s care of patients is being based – and should be perceived as being based – solely on each patient’s medical needs and the health care professional’s medical knowledge. The PhRMA Code reaffirms that interactions between company representatives and health care professionals should be focused on providing information on products, scientific and educational information, and supporting medical education.
Physician: Any Medical Doctor (M.D.) or Doctor of Osteopathic Medicine (D.O.) who has an active state medical license that allows him/her to prescribe medicine
Principal Investigator: The principal investigator is the primary physician responsible for the study of potential Lilly medicines or investigator-initiated trials. For Lilly sponsored studies, these individuals enter into a contract with Lilly to administer investigational medicines, oversee patient care, and collect data as a critical part of the research and development process. *Importantly, clinical study payments do not reflect the actual compensation, if any, received by the physician listed as the principal investigator.
Research Related Payments*: Payments made for basic research, Phase I-IV clinical studies, trials initiated by an investigator (IITs), other research and development consulting, and other services performed by U.S.-based physicians in support of research and development. Payments for clinical studies include costs associated with patient care including: diagnostics, exams, and laboratory expenses, as well as the time spent by health care professionals treating the patient and managing the study. *Importantly, clinical study payments do not reflect the actual compensation, if any, received by the physician listed as the principal investigator.