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.
Lilly Faculty provide insights and recommendations on a variety of commercial topics. Lilly relies upon health care professionals’ expertise to develop education and commercialization materials, to train other health care professionals on these materials, to assist in complex data analysis, and to evaluate changes in treatment and patient care.
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.
Materials created by Lilly to promote and build awareness of Lilly products among health care professionals and patients.
Payments made to Lilly Faculty for services provided to Lilly. Excludes reimbursed expenses.
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.
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.
The study of factors affecting the health of a population or disease in a population and the consideration of those factors in creating medicines to help control disease.
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.
Health Care Professional Education Programs
These speaker programs, led by Lilly Faculty, are designed to enhance health care professionals’ knowledge and patient care expertise. Speakers address such topics as advances in disease research, diagnosis, and epidemiology. Speakers also address treatment options, a medicine’s effectiveness, side effects, and safety history. All U.S.-based programs that include product information must be consistent with U.S. Food and Drug Administration approved labeling. Furthermore, product-related educational materials for use in the United States are submitted to the FDA at or prior to time of first use.
International Education Programs
International Education Programs are speaker programs by U.S.-based Lilly Faculty that take place outside of the United States and are governed by local laws and regulations.
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 are external U.S.-based health care professionals contracted and compensated by Lilly to provide services such as commercial advising, health care professional education, and patient education programs.
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.
OPEN PAYMENTS is the official website for the National Physician Payment Transparency Program (Section 6002 of the Affordable Care Act, “Sunshine Act”). Its purpose is creating public transparency of industry-physician financial relationships.
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.
Patient Education Programs
Lilly contracts with credentialed educators to help inform patients and their caregivers on the proper use of certain Lilly medications – such as those used with injection devices – that have been prescribed to the patients. Educators may also provide disease and medication administration education to prescribing health care professionals and their office staff. All patient education is provided only upon referral by the prescribing health care professional.
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.
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.
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.